WO2024231160A1 - Pharmaceutical or cosmetic composition for promoting hair growth - Google Patents
Pharmaceutical or cosmetic composition for promoting hair growth Download PDFInfo
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- WO2024231160A1 WO2024231160A1 PCT/EP2024/061766 EP2024061766W WO2024231160A1 WO 2024231160 A1 WO2024231160 A1 WO 2024231160A1 EP 2024061766 W EP2024061766 W EP 2024061766W WO 2024231160 A1 WO2024231160 A1 WO 2024231160A1
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- WIPO (PCT)
- Prior art keywords
- mass
- composition
- hair
- digalactosyldiacylglycerol
- sphingosine
- Prior art date
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Definitions
- the invention relates to the field of cosmetics and pharmacy. It concerns the treatment for promoting hair growth.
- the hair fiber consists of a visible shaft, a hair bulb, located under the surface of the scalp, and a dermal papilla located at the base of the bulb.
- the shaft is made up of three concentric layers: the medulla, the cortex and the cuticle.
- the medulla is the central part, while the cortex is the intermediate layer and constitutes the body of the hair.
- the cortex is composed of long chains of keratin which give the hair its elasticity, flexibility and resistance.
- the hair fiber is protected by the cuticle, formed by keratin scales sealed to each other by an intercellular cement rich in lipids and in particular ceramides. These lipid substances ensure the barrier function of the hair by giving it a certain impermeability.
- the shaft is surrounded by two sheaths: the outer epithelial sheath, which has a composition similar to the epidermis, and the inner epithelial sheath, rich in glycoproteins, constituting the nourishing base of the developing hair.
- the hair bulb is composed of keratinocytes whose active division is responsible for the formation of the hair shaft, as well as the inner and outer epithelial sheaths.
- the dermal papilla is a highly vascularized area and is the site of the cell multiplication necessary for hair growth. It is composed of fibroblasts and provides nutrition, irrigation, oxygenation and the elimination of cellular waste from the hair. Hair grows according to a growth cycle composed of three successive phases: the anagen phase (growth phase), the catagen phase (regression phase) and the telogen phase (resting phase).
- the anagen phase is a growth phase, lasting on average 2 to 4 years in men and up to 6 years in women. This phase is characterized by rapid proliferation and differentiation of keratinocytes to form the hair and epithelial sheaths.
- the intense metabolic activity at the bulb level leads to the formation of keratin, a protein essential to the composition of hair.
- the catagen phase is a regression phase, lasting a short time of two to three weeks, constituting the transition phase between the growth phase and the resting phase.
- This phase is characterized by the involution of the hair follicle by a phenomenon of programmed death. Cell differentiation decreases until it stops. The volume of the bulb decreases, the latter rises towards the surface of the epidermis until it causes the physical link with the dermal papilla to break. This phase concerns approximately 1% of the hair.
- the telogen phase is a resting phase preceding hair loss, lasting an average of two to three months. This phase is characterized by an absence of cell proliferation.
- the dead hair remains attached to the hair follicle, and falls out when it is pushed back by a new hair, for which a new anagen phase begins.
- This phase concerns approximately 10 to 15% of the hair.
- this hair cycle can be altered.
- stress, fatigue, pollution, hormonal imbalance or drug treatment can cause abundant and non-localized hair loss, called telogen effluvium.
- telogen effluvium the proportion of hair in the telogen phase increases, which can be greater than 20%. This is called telogen effluvium.
- This disorder generally lasts between two and four months and is accompanied by a weakening of the hair structure.
- the proportion of hair in the anagen and telogen phases can be assessed by performing a phototrichogram, a standardized method measuring the fundamental parameters related to hair growth.
- the phototrichogram is performed on a fixed area of the scalp with a diameter of 1.8 cm (frontotemporal region or vertex).
- the hair is shaved before an initial macrophotograph to count the total hair; a second macrophotograph taken 48 hours later then makes it possible to differentiate the anagen hair that has grown from the telogen hair that has not grown.
- compositions derived from wheat gluten extracts are capable of promoting hair growth (or growth), particularly in people suffering from alopecia or telogen effluvium.
- the invention thus relates to a composition (C) characterized in that it is a wheat gluten extract, comprising for 100% by mass: - from 20% by mass to 80% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass of at least one phospholipid (a3), and in that the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), is equal to 100% by mass, for its oral use, in a therapeutic treatment method for promoting hair growth and more particularly for increasing the density and length of hair.
- a wheat gluten extract comprising for 100% by mass: - from 20% by
- sphingolipids means complex lipids resulting from the amidation of a fatty acid on sphingosine.
- Sphingosine is an amido-diol having an ethylenic double bond; called 2-amino-octadec-4-ene-1,3-diol and of formula (I): a sub-monoester group or and phosphoethanolamines, phosphatidylinositol, lysophosphatidylethanolamines, phosphatidic acids, phosphatidylcholine and lysophosphatidylcholines.
- the composition (C) as defined above comprises for 100% by mass from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine.
- the composition (C) as defined above comprises for 100% by mass from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2).
- the composition (C) as defined above comprises for 100% by mass from 1% by mass to 10% by mass, of at least one phospholipid (a3).
- the invention more particularly relates to a composition (C) comprising for 100% by mass: - from 20% by mass to 60% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 19% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 10% by mass of at least one phospholipid (a3) for its oral use, in a therapeutic treatment method for increasing the density and length of hair.
- the composition (C) as defined above is in oily form or in powder form.
- Said composition (C) as defined above is prepared by methods known to those skilled in the art and more particularly that described in the international patent application published under number WO 99/65459, on pages 8 to 11. It is more particularly prepared according to a process comprising the following successive steps: - At least one step a) of providing wheat gluten flour, - At least one step b) of adding the wheat gluten flour to ethanol (97% minimum) with mechanical stirring for a period of at least two hours and at a temperature of 60°C, - At least one step c) of spinning followed by a sub-step of decanting the mixture obtained in step b) so as to recover a homogeneous liquid phase, - At least one step d) of vacuum distillation of the liquid obtained during step c), at a temperature less than or equal to 35°C to remove the ethanol so as to obtain a concentrated composition, - At least one step e) of adding the product obtained at the end of step d) to ethanol, with mechanical stirring and at a temperature of 4°C, so as to
- the present invention also relates to an edible pharmaceutical composition (Cp) comprising for 100% by mass: - more than 0% by mass to 30% by mass of said composition (C) as defined above and - from 70% by mass to less than 100% by mass of at least one pharmaceutically acceptable edible technological additive, for its oral use, in a therapeutic treatment method for increasing the density and length of hair.
- an edible pharmaceutical composition comprising for 100% by mass: - more than 0% by mass to 30% by mass of said composition (C) as defined above and - from 70% by mass to less than 100% by mass of at least one pharmaceutically acceptable edible technological additive, for its oral use, in a therapeutic treatment method for increasing the density and length of hair.
- said edible pharmaceutical composition (Cp) comprises for 100% by mass: - from 10% by mass to 30% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass, and said
- “Technological additive” means any chemical substance or chemical composition whose technical function is to enable and/or facilitate the mixing of the various constituents of said edible composition, to facilitate and/or optimize the physical properties of said edible composition, as well as to facilitate and/or optimize its flow, stability, and incorporation into a subsequent pharmaceutical and/or nutritional formulation, and which are capable of complying with the conditions required by the regulations in force for the placing on the market of a pharmaceutical formulation and/or a nutritional formulation.
- a pharmaceutically acceptable technological additive means a technological additive whose use meets the requirements of the pharmaceutical regulations in force in a country concerned. According to a particular aspect of the invention, said pharmaceutically acceptable edible technological additive is selected from a diluting agent, a flow agent, a binding agent or a disintegrating agent.
- diluting agent there are for example lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomalt, calcium hydrogen phosphate, microcrystalline cellulose, starches such as corn, wheat or potato starches, dicalcium phosphate, sodium, calcium or magnesium carbonates, monoglycerides and/or diglycerides of fatty acids comprising from 8 to 24 carbon atoms.
- flow agents include magnesium stearate, talc, sodium stearyl fumarate, hydrogenated vegetable oils, colloidal anhydrous silica, sodium benzoate or silicon dioxide.
- binding agents include starches in the form of starch, pregelatinized starches, hydroxypropylmethyl cellulose (HPMC), methylcellulose, sucrose syrups or gum acacia.
- disintegrating agents include starches, sodium starch glycolate, alginic acid, sodium alginate, croscarmellose sodium, crospovidone or polyvinylpyrrolidone.
- said edible pharmaceutical composition (Cp) as defined above further comprises at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.
- active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.
- phytosterols such as those extracted from vegetable oils, and more particularly extracts of sea buckthorn oil, corn oil or soybean oil
- phytosterol complexes isolated from vegetable oils such as cholestatin composed of campesterol, stigmasterol and brassicasterol
- phytostanols phytostanols
- carotenoids which belong to the family of terpenoids extracted from algae, green plants, fungi, bacteria
- polyunsaturated fatty acids of the omega-3 group such as alpha-linoleic acid, eicosapentaenoic acid, docosahexaenoic acid
- polyunsaturated fatty acids of the omega-6 group such as linoleic acid, g-linoleic acid, eicosadienoic acid, dihomo-y-linoleic acid, arachidonic acid, docosadienoic acid, docosatetraenoic
- salts of water-soluble or water-dispersible trace elements possibly present in said edible pharmaceutical composition (Cp) as defined above there are for example ferrous carbonate, ferrous chloride tetrahydrate, ferric chloride hexahydrate, ferrous citrate hexahydrate, ferrous fumarate, ferrous lactate tetrahydrate, ferrous sulfate monohydrate, ferrous sulfate heptahydrate, ferrous chelate of amino acids hydrates, iron chelate of glycine; calcium iodate hexahydrate, anhydrous calcium iodate; sodium iodide, potassium iodide; cobalt acetate tetrahydrate, basic cobalt carbonate monohydrate, cobalt carbonate hexahydrate, cobalt sulfate heptahydrate, cobalt sulfate monohydrate, cobalt nitrate hexahydrate; cupric acetate monohydrate, basic copper carbonate monohydrate, cupric chloride dihydrate
- vitamin A more particularly in its form of retinol, retinyl acetate, retinyl palmitate or ⁇ -carotene
- vitamin D2 more particularly in its form of dergocalciferol, or 25-hydroxy calciferol
- vitamin D3 more particularly in its form of cholecalciferol
- vitamin K more particularly in its form of phylloquinone (phytomenadione) or menaquinone
- vitamin B1 more particularly in its form of thiamine hydrochloride, thiamine mononitrate, thiamine chloride monophosphate, or thiamine chloride pyrophosphate
- vitamin B2 more particularly in its form of riboflavin, sodium riboflavin 5'-phosphate
- vitamin B6 more particularly in its form of pyridoxine hydrochloride, pyridoxine 5'-phosphate, or pyridoxal 5'-
- prebiotics possibly present in said edible pharmaceutical composition (Cp) as defined above there are for example inulin, trans-galacto-oligosaccharides, fructans and manno-oligosaccharides.
- probiotics possibly present in said edible pharmaceutical composition (Cp) as defined above there are different strains of Saccharomyces cerevisiae, Bacillus cereus var. toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or strains of Enteroccocus faecium. These strains of microorganisms are generally associated with a solid support, for example calcium carbonate, dextrose or sorbitol.
- proteins and/or protein concentrates possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example milk proteins derived from milk, such as colostrum in the form of freeze-dried or atomized powder or whey in the form of powder, purified fractions or enriched with IgG, lactoferrin, lactoperoxidase.
- plant or animal enzymes possibly present in the edible pharmaceutical composition (Cp) as defined above, there are for example promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-betaglucanases, endo-1,4-betaxylanases, or other enzymes improving or promoting digestion.
- peptides possibly present in said edible pharmaceutical composition (Cp) as defined above there are for example avocado peptides, lupin, quinoa peptides, maca peptides, fermented or unfermented soybean peptides, rice peptides, peptides present in Acacia macrostachya seed extract, peptides present in passionflower seed extracts.
- amino acids possibly present in said edible pharmaceutical composition (Cp) as defined above there are for example alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxy-proline, pyrrolysine, selmeno-cysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, ornithine.
- alanine arginine
- asparagine aspartic acid
- cysteine glutamic acid
- glutamine glycine
- histidine isoleucine
- leucine leucine
- lysine methionine
- phenylalanine proline
- hydroxy-proline pyrrolysine
- selmeno-cysteine serine
- sugars possibly present in said edible pharmaceutical composition (Cp) as defined above there are for example water-soluble polysaccharides, sugars of lower molecular weight, such as oligosaccharides, mono- or disaccharides, such as for example glucose, lactose, dextrose.
- flavor enhancers possibly present in the edible pharmaceutical composition (Cp) as defined above, there are for example glutamates, such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, magnesium diglutamate; guanylates, such as for example guanylic acid (guanosine monophosphate), disodium guanylate, dipotassium guanylate, calcium guanylate, inosinates, such as for example inosinic acid, disodium inosinate, dipotassium inosinate, calcium inosinate, or intense sweeteners such as Stevia extracts, Rebiaudosides.
- Said edible pharmaceutical composition (Cp) may be in solid or liquid form.
- said edible pharmaceutical composition (Cp) is in the form of a solid, and more particularly the form of a tablet, a capsule, a soft capsule, a powder, a dragée, a confectionery gum or a granule.
- the edible pharmaceutical composition (Cp) as defined above when in the form of a tablet, it preferably comprises from 50 mg to 150 mg of said composition (C) as defined above, for a 500 mg tablet; when it is in the form of a soft capsule, it preferably comprises from 120 mg to 360 mg of said composition (C) for a 1200 mg soft capsule; when it is in the form of a gelatin capsule, it preferably comprises from 10 mg to 30 mg of composition (C) for a 100 mg gelatin capsule; when it is in the form of a powder, it preferably comprises from 200 mg to 600 mg of composition (C) for a powder of 2000 mg.
- the edible pharmaceutical composition (Cp) When the edible pharmaceutical composition (Cp) is in the form of a powder, it is obtained by introducing its various constituents into a mixer equipped with at least one mechanical stirring system, such as for example flat or propeller-type stirring blades, and the mixer is optionally a turning mixer, and the mixer is optionally equipped with a lump-forming system. This mixing operation is generally carried out at room temperature, in particular between 15°C and 30°C.
- the edible pharmaceutical composition (Cp) is in the form of a confectionery gum, it preferably comprises from 150 mg to 450 mg of composition (C) for a confectionery gum of 1.5 g.
- the edible pharmaceutical composition (Cp) when in the form of a liquid, it preferably comprises from 100 mg to 300 mg of composition (C) for a 1 cm3 ampoule.
- the invention also relates to the use in oral administration of an effective amount of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, of said digalactosy
- the invention also relates to a cosmetic treatment method intended to increase the density and length of the hair, characterized in that an effective amount of a composition (C) comprising for 100% by mass is administered orally: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to
- hair growth or “hair growth” means the increase in hair length and/or hair regrowth characterized by an increase in the total density of the hair, the density and the proportion of hair in the anagen phase.
- effective amount means a sufficient amount that allows the consumer of average attention to visually observe the reality of the aesthetic aspect invoked with regard to the growth of his or her own hair, in particular the increase in hair length and/or hair regrowth.
- the experimental study set out in the remainder of the present description shows that an amount of between 1 mg and 250 mg, more particularly between 10 mg and 150 mg, even more particularly between 15 mg and 100 mg, and even more particularly between 30 mg and 70 mg of said composition, ingested per day, can be considered an effective amount.
- the present invention also relates to a food supplement (Ca) comprising for 100% by mass: - More than 0% by mass to 30% by mass of said composition (C) as defined above and - from 70% by mass to less than 100% by mass of at least one nutritionally acceptable technological additive.
- the food supplement (Ca) as defined above comprises for 100% by mass: - more than 0% by mass and less than 10% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting of the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to
- a dietary supplement is an edible composition whose purpose is to supplement the normal diet and which constitutes a concentrated source of nutrients or other substances having a nutritional or physiological effect alone or in combination.
- a dietary supplement helps to avoid certain deficiencies or to meet specific needs in an individual's diet, particularly during physical exertion.
- This definition of "dietary supplement” is given in Article 2 of Decree No. 2006-352 of March 26, 2006 of the French Republic relating to food supplements and in Directive 2002/46/EC of the European Parliament and of the Council of June 10, 2002.
- a "nutritionally acceptable technological additive” means a technological additive as defined above, the use of which meets the requirements of the regulations relating to food supplements in force in a given country.
- said nutritionally acceptable technological additive is chosen from a diluting agent, a flow agent, a binding agent or a disintegrating agent.
- diluting agent there are for example lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomalt, calcium hydrogen phosphate, microcrystalline cellulose, starches such as corn, wheat or potato starches, dicalcium phosphate, sodium, calcium or magnesium carbonates, monoglycerides and/or diglycerides of fatty acids comprising from 8 to 24 carbon atoms.
- Examples of flow agents include magnesium stearate, talc, sodium stearyl fumarate, hydrogenated vegetable oils, colloidal anhydrous silica, sodium benzoate or silicon dioxide.
- binding agents there are for example starches in the form of starch, pregelatinized starches, hydroxypropylmethyl cellulose (HPMC), methylcellulose, sucrose syrups or gum acacia.
- disintegrating agents there are for example starches, sodium starch glycolate, alginic acid, sodium alginate, croscarmellose sodium, crospovidone, or polyvinylpyrrolidone.
- said food supplement (Ca) as defined above further comprises at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.
- active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.
- phytosterols such as those extracted from vegetable oils, and more particularly extracts of sea buckthorn oil, corn oil, or soybean oil; phytosterol complexes isolated from vegetable oils, such as cholestatin composed of campesterol, stigmasterol and brassicasterol; phytostanols; carotenoids, which belong to the family of terpenoids extracted from algae, green plants, fungi, bacteria; polyunsaturated fatty acids of the omega-3 group, such as alpha-linoleic acid, eicosapentaenoic acid, docosahexaenoic acid; polyunsaturated fatty acids of the omega-6 group, such as linoleic acid, g-linoleic acid, eicosadienoic acid, dihomo-y-linoleic acid, arachidonic acid, docosadienoic acid, docosatetraenoic
- phytosterols such as those extracted from vegetable oils, and more particularly extracts of sea buckt
- salts of water-soluble or water-dispersible trace elements possibly present in said food supplement (Ca) as defined above there are for example ferrous carbonate, ferrous chloride tetrahydrate, ferric chloride hexahydrate, ferrous citrate hexahydrate, ferrous fumarate, ferrous lactate tetrahydrate, ferrous sulfate monohydrate, ferrous sulfate heptahydrate, ferrous chelate of amino acids hydrates, iron chelate of glycine; calcium iodate hexahydrate, anhydrous calcium iodate; sodium iodide, potassium iodide; cobalt acetate tetrahydrate, basic cobalt carbonate monohydrate, cobalt carbonate hexahydrate, cobalt sulfate heptahydrate, cobalt sulfate monohydrate, cobalt nitrate hexahydrate; cupric acetate monohydrate, basic copper carbonate monohydrate, cupric chloride dihydrate,
- vitamin A more particularly in its form of retinol, retinyl acetate, retinyl palmitate or ⁇ -carotene
- vitamin D2 more particularly in its form of dergocalciferol, or 25-hydroxy calciferol
- vitamin D3 more particularly in its form of cholecalciferol
- vitamin K more particularly in its form of phylloquinone (phytomenadione) or Menaquinone
- vitamin B1 more particularly in its form of thiamine hydrochloride, thiamine mononitrate, thiamine chloride monophosphate, or thiamine chloride pyrophosphate
- vitamin B2 more particularly in its form of riboflavin, sodium riboflavin 5'-phosphate
- vitamin B6 more particularly in its form of pyridoxine hydrochloride, pyridoxine 5'-phosphate, or pyridoxal 5'-phosphat
- prebiotics possibly present in said food supplement (Ca) as defined above there are for example inulin, trans-galacto-oligosaccharides, fructans and manno-oligosaccharides.
- probiotics possibly present in said food supplement (Ca) as defined above there are different strains of Saccharomyces cerevisiae, Bacillus cereus var toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or strains of Enteroccocus faecium. These strains of microorganisms are generally associated with a solid support, for example calcium carbonate, dextrose or sorbitol.
- milk proteins from milk such as colostrum in the form of freeze-dried or atomized powder or whey in the form of powder, purified fractions or enriched with IgG, lactoferrin, lactoperoxidase.
- plant or animal enzymes possibly present in said food supplement (Ca) as defined above, there are for example promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-betaglucanases, endo-1,4-betaxylanases, or other enzymes improving or promoting digestion.
- peptides possibly present in said food supplement (Ca) as defined above there are for example avocado peptides, lupin peptides, quinoa peptides, maca peptides, fermented or non-fermented soy peptides, rice peptides, peptides present in Acacia macrostachya seed extract, peptides present in passionflower seed extracts.
- amino acids possibly present in said food supplement (Ca) as defined above there are for example alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxy-proline, pyrrolysine, selmeno-cysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, ornithine.
- sugars possibly present in said food supplement (Ca) as defined above there are for example water-soluble polysaccharides, sugars of weight lower molecular weight, such as oligosaccharides, mono- or disaccharides, such as glucose, lactose, dextrose.
- sweeteners possibly present in said food supplement (Ca) as defined above, there are for example glutamates, such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, magnesium diglutamate; guanylates, such as guanylic acid (guanosine monophosphate), disodium guanylate, dipotassium guanylate, calcium guanylate, inosinates, such as inosinic acid, disodium inosinate, dipotassium inosinate, calcium inosinate, or intense sweeteners such as Stevia extracts, Rebiaudosides.
- Said food supplement (Ca) can be in solid or liquid form.
- Said food supplement (Ca) may be in any form of food product known to those skilled in the art, such as a drink, and more particularly an aqueous drink, a solution, a fruit juice, a flavored drink, an energy drink, an alcoholic drink, a coffee-based drink, a chocolate-based drink, a tea-based drink, a dairy product, and more particularly milk, yogurt, a dairy dessert, drinkable yogurt, cheese, ice cream, a chocolate bar, a cereal product, and more particularly a cereal bar, a biscuit, breakfast cereals, flours, bakery products, a specialized nutrition product, more particularly an infant nutrition product, a nutrition product to prepare for physical exercise, a clinical nutrition product, a meal replacement, confectionery, more particularly chewing gum, sweets, caramels, sugared almonds, berlingots, marshmallows, lokoums, nougats, fruit pastes, liquorice.
- a drink and more particularly an aqueous drink, a solution, a fruit juice, a flavored drink
- the food supplement (Ca) according to the invention may also be in any galenic form known to those skilled in the art, such as for example in the form of a tablet, a capsule, a soft capsule, a syrup, a powder, such as for example an immediate-release powder, a delayed-release powder or a powder for reconstituted drinks, a liquid, a stick, a gel.
- said food supplement (Ca) as defined above is in the form of a solid, and more particularly the form of a tablet, a capsule, a soft capsule, a powder, a dragée, a confectionery gum or a granule.
- said food supplement (Ca) as defined above is in the form of a tablet, it preferably comprises less than 50 mg of said composition (C) such that defined above, for a 500 mg tablet; when it is in the form of a soft capsule, it preferably comprises less than 120 mg of said composition (C) for a 1200 mg soft capsule; when it is in the form of a gelatin capsule, it preferably comprises less than 10 mg of said composition (C) as defined above for a 100 mg gelatin capsule; when it is in the form of a powder, it preferably comprises less than 200 mg of said composition (C) as defined above for a 2000 mg powder.
- said food supplement (Ca) When said food supplement (Ca) is in the form of a powder, it is obtained by introducing its various constituents into a mixer equipped with at least one mechanical stirring system, such as for example flat or propeller-type stirring blades, and the mixer is optionally a percolator mixer, and the mixer is optionally equipped with a lump-chopper system. This mixing operation is generally carried out at room temperature, in particular between 15°C and 30°C.
- said food supplement (Ca) When said food supplement (Ca) is in the form of a confectionery gum, it preferably comprises less than 150 mg of said composition (C) as defined above for a 1.5 g confectionery gum.
- the food supplement (Ca) When the food supplement (Ca) is in the form of a liquid, it preferably comprises less than 100 mg of said composition (C) as defined above for a 1 cm 3 ampoule.
- the present invention also relates to the cosmetic use in oral administration of the food supplement (Ca) as defined above, to increase the density and length of hair.
- the present invention relates to a cosmetic treatment method intended to increase the density and length of hair, characterized in that an effective amount of the food supplement (Ca) as defined above is administered orally.
- said food supplement (Ca) as defined above is administered orally at a rate of at least 15 mg, in particular at least 30 mg, of said composition (C) per day for at least 4 weeks, in particular for at least 8 weeks, even more particularly for 12 weeks.
- the following examples illustrate the invention, without however limiting it.
- Comparative formulations A commercial wheat gluten extract is used in the form of a powdery composition (C) which comprises for 100% of its mass: 52.5% by mass of sphingolipids, 41.5% by mass of DigalactosylDiacylGlycerol and 6% by mass of phospholipids.
- composition (C) comprising composition (C)
- C'a not comprising composition (C)
- Table 1 Amount per capsule Components Dietary supplement (Ca) Dietary supplement (C'a) Composition (C) 15 mg - Maltodextrin 230 mg 245 mg Dicalcium phosphate 100 mg 100 mg Magnesium carbonate 50 mg 50 mg Silica 30 mg 30 mg Magnesium stearate 10 mg 10 mg Total net weight 435 mg 435 mg Total weight 549 mg 549 mg (including capsule weight) 5 Procedure The technical effect of composition (C) was demonstrated in a pilot, randomized, double-blind, parallel-group clinical study.
- A.1- Hair length Principle of the evaluation method Hair growth was evaluated by measuring the length of 5 hairs after 84 days of supplementation, following their shaving on D0. The improvement in hair growth was also highlighted by the study subjects, thanks to the use of a self-assessment form. Results The results obtained are presented in Table 2.
- A.2- Hair regrowth Principle of the evaluation method Hair regrowth was evaluated by performing a phototrichogram, allowing the density and proportion of hair in the anagen and telogen phases to be quantified. As a reminder, the phototrichogram is performed on a fixed area of the scalp with a diameter of 1.8 cm (frontotemporal region or vertex).
- the hair is shaved there, before coloring the area and taking a first macrophotograph allowing the total hair to be counted; A second macrophotograph taken 48 hours later then allows to differentiate the anagen hairs that have grown from the telogen hairs that have not grown.
- the total hair density is evaluated by the total number of hairs per cm2.
- the anagen hair density is evaluated by the number of hairs in the anagen phase (having grown during the 48 hours between the 2 macrophotographs) per cm2 and proportion (%) compared to the total hair density. Hair regrowth was also analyzed through a clinical evaluation carried out by a dermatologist as well as using a self-assessment form completed by the study subjects.
- composition (C) demonstrated activity in promoting hair growth, through its effect on increasing hair length, and its effect on anagen density and total density.
- Examples of illustrative formulations [Table 6] Clinical Study Capsule Formula Component Amount per Capsule Composition (C) 15 mg Maltodextrin 230 mg Dicalcium Phosphate 100 mg Magnesium Carbonate 50 mg Silica 30 mg Magnesium Stearate 10 mg [Table 7] Capsule Formula Component Amount per Capsule Composition (C) 30 mg Maltodextrin 220 mg Beet Juice 70 mg Magnesium Stearate 15 mg 5
Abstract
Composition (C) comprising, for 100% by mass: from 20% by mass to 80% by mass of at least one sphingolipid (a1), from 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and from 1% by mass to 30% by mass of at least one phospholipid (a3), for use in a therapeutic treatment method for promoting hair growth. Pharmaceutical composition (Cp) and food supplement (Ca) comprising said composition (C). Non-therapeutic use of said food supplement (Ca) and non-therapeutic method of implementation.
Description
COMPOSITION PHARMACEUTIQUE OU COSMETIQUE FAVORISANT LA CROISSANCE DES CHEVEUX L’invention relève du domaine de la cosmétique et de la pharmacie. Elle concerne le traitement pour favoriser la croissance des cheveux. La fibre capillaire se compose d'une tige visible, d'un bulbe pileux, situé sous la surface du cuir chevelu, et d'une papille dermique située à la base du bulbe. La tige est constituée de trois couches concentriques: la moelle, le cortex et la cuticule. La moelle est la partie centrale, tandis que le cortex est la couche intermédiaire et constitue le corps du cheveu. Le cortex est composé de longues chaînes de kératine qui donnent au cheveu leur élasticité, leur souplesse et leur résistance. La fibre capillaire est protégée par la cuticule, formée par des écailles de kératine scellées les unes aux autres par un ciment intercellulaire riche en lipides et notamment en céramides. Ces substances lipidiques assurent la fonction barrière du cheveu en lui conférant une certaine imperméabilité. A sa base, la tige est entourée de deux gaines: la gaine épithéliale externe, qui présente une composition voisine de l’épiderme, et la gaine épithéliale interne, riche en glycoprotéines, constituant l’assise nourricière du cheveu en développement. Le bulbe pileux est composé de kératinocytes dont la division active est responsable de la formation de la tige du cheveu, ainsi que des gaines épithéliales interne et externe. La papille dermique est une zone très vascularisée et constitue le siège de la multiplication cellulaire nécessaire à la croissance du cheveu. Elle est composée de fibroblastes et assure la nutrition, l'irrigation, l'oxygénation et l'élimination des déchets cellulaires des cheveux. Les cheveux poussent selon un cycle de croissance composé de trois phases successives: la phase anagène (phase de croissance), la phase catagène (phase de régression) et la phase télogène (phase de repos). La phase anagène est une phase de croissance, durant en moyenne 2 à 4 ans chez l’homme et jusqu’à 6 ans chez la femme. Cette phase est caractérisée par une rapide prolifération et différenciation des kératinocytes pour constituer le cheveu et les gaines épithéliales. L’activité métabolique intense au niveau du bulbe entraîne la formation de kératine, protéine essentielle à la composition des cheveux. Dans des conditions normales, environ 85% de la chevelure se trouve en phase anagène. La phase catagène est une phase de régression, d’une durée brève de deux à trois semaines, constituant la phase de transition entre la phase de croissance et la phase de repos. Cette phase est caractérisée par l’involution du follicule pileux par un phénomène de mort programmée.
La différentiation cellulaire diminue jusqu’à s’interrompre. Le volume du bulbe décroît, ce dernier monte vers la surface de l’épiderme jusqu’à entraîner la rupture du lien physique avec la papille dermique. Cette phase concerne environ 1% de la chevelure. La phase télogène est une phase de repos précédant la chute du cheveu, d’une durée moyenne de deux à trois mois. Cette phase est caractérisée par une absence de prolifération cellulaire. Le cheveu mort reste attaché au follicule pileux, et tombe quand il est refoulé par un nouveau cheveu, pour lequel une nouvelle phase anagène commence. Cette phase concerne environ 10 à 15% de la chevelure. Sous l’influence de différents facteurs, ce cycle capillaire peut être altéré. En particulier, le stress, la fatigue, la pollution, un déséquilibre hormonal ou un traitement médicamenteux peut entraîner une chute abondante et non localisée de cheveux, appelé effluvium télogène. Dans ce cas, la proportion de cheveux en phase télogène augmente, pouvant être supérieure à 20%. On parle ainsi d'effluvium télogène. Ce dérèglement dure généralement entre deux et quatre mois et s’accompagne d’une fragilisation de la structure du cheveu. La proportion de cheveux en phase anagène et télogène peut être évaluée par la réalisation d’un phototrichogramme, une méthode standardisée mesurant les paramètres fondamentaux liés à la pousse du cheveu. Le phototrichogramme est réalisé sur une zone fixe du cuir chevelu d’un diamètre de 1,8 cm (région fronto-temporale ou vertex). Les cheveux y sont rasés avant une première macrophotographie permettant le comptage des cheveux totaux; une deuxième macrophotographie faite 48 heures plus tard permet ensuite de différencier les cheveux anagènes ayant poussé des cheveux télogènes n'ayant pas poussé. Dans le cadre de leurs recherches visant à développer l’utilisation en thérapie et en cosmétique de composés naturels, les inventeurs ont mis en évidence que l’utilisation d’une composition provenant d’extraits de gluten de blé, administrés par voie orale, est capable de favoriser la croissance (ou la pousse) des cheveux, notamment chez les personnes atteintes d'alopécie ou d'effluvium télogène. Selon un premier aspect, l’invention a ainsi pour objet une composition (C) caractérisée en ce qu’il s’agit d’un extrait de gluten de blé, comprenant pour 100% massique : - de 20% massique à 80% massique d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique d’au moins un phospholipide (a3), et en ce que la somme des teneurs massiques dudit au moins un sphingolipide (a1)
résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), est égale à 100% massique, pour son utilisation par voie orale, dans une méthode de traitement thérapeutique pour favoriser la pousse des cheveux et plus particulièrement pour augmenter la densité et la longueur des cheveux. Par « sphingolipides » on entend au sens de la présente invention des lipides complexes, résultant de l’amidification d’un acide gras sur la sphingosine. La sphingosine est un amido- diol possédant une double liaison éthylénique ; dénommé 2-amino-octadec-4-ène-1,3-diol et de formule (I) :
un groupe sous mono-ester ou et des phosphoéthanolamines, des phosphatidylinositol, des lysophosphatidyléthanolamines, des acides phosphatidiques, des phosphatidylcholine et des lysophosphatidylcholines. Selon un premier aspect particulier, la composition (C) telle que définie ci-dessus comprend pour 100% massique de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine. Selon un deuxième aspect particulier, la composition (C) telle que définie ci-dessus comprend pour 100% massique de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2). Selon un troisième aspect particulier, la composition (C) telle que définie ci-dessus comprend pour 100% massique de 1% massique à 10% massique, d’au moins un phospholipide (a3). L’invention a plus particulièrement pour objet une composition (C) comprenant pour 100% massique : - de 20% massique à 60% massique d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 19% massique à 50% massique de digalactosyldiacylglycérol (a2), et - de 1% massique à 10% massique d’au moins un phospholipide (a3) pour son utilisation par voie orale, dans une méthode de traitement thérapeutique pour augmenter la densité et la longueur des cheveux.
Selon un autre aspect particulier de l’invention, la composition (C) telle que définie ci-dessus est sous forme huileuse ou sous forme pulvérulente. Ladite composition (C) telle que définie ci-dessus, est préparée par des méthodes connues de l’homme du métier et plus particulièrement celle décrite dans la demande internationale de brevet publiée sous le numéro WO 99/65459, aux pages 8 à 11. Elle est plus particulièrement préparée selon un procédé comprenant les étapes successives suivantes : - Au moins une étape a) de mise à disposition de farine de gluten de blé, - Au moins une étape b) d’addition de la farine de gluten de blé dans de l’éthanol (97% minimum) sous agitation mécanique pendant une durée d’au moins deux heures et à une température de 60°C, - Au moins une étape c) d’essorage suivie d’une sous-étape de décantation du mélange obtenu à l’étape b) de façon à récupérer une phase liquide homogène, - Au moins une étape d) de distillation sous vide du liquide obtenu lors de l’étape c), à une température inférieure ou égale à 35°C pour éliminer l’éthanol de façon à obtenir une composition concentrée, - Au moins une étape e) d’ajout du produit obtenu à l’issue de l’étape d) sur de l’éthanol, sous agitation mécanique et à une température de 4°C, de façon à faire précipiter le milieu et à récupérer la partie liquide, - Au moins une étape f) de distillation du liquide obtenu à l’issu de l’étape e) pour éliminer l’éthanol et obtenir une composition huileuse, - Au moins une étape g) d’ajout de la composition (C) sur de l’acétone de façon à obtenir un précipité, - Au moins une étape h) de filtration du milieu obtenu à l’issue de l’étape g) permettant de récupérer un solide pulvérulent, - de séchage du gâteau solide obtenu à l’issue de l’étape g) pour obtenir une composition sous forme de poudre. La présente invention a également pour objet une composition pharmaceutique comestible (Cp) comprenant pour 100% massique : - plus de 0% massique à 30% massique de ladite composition (C) telle que définie ci- dessus et - de 70% massique à moins de 100% massique d’au moins un additif technologique comestible pharmaceutiquement acceptable, pour son utilisation par voie orale, dans une méthode de traitement thérapeutique pour augmenter la densité et la longueur des cheveux.
De préférence, ladite composition pharmaceutique comestible (Cp) comprend pour 100% massique : - de 10% massique à 30% massique d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique, et ladite composition (C) étant un extrait de gluten de blé, et - de 70% massique à 90% massique d’au moins un additif technologique comestible pharmaceutiquement acceptable, pour son utilisation par voie orale, dans une méthode de traitement thérapeutique pour augmenter la densité et la longueur des cheveux, plus particulièrement chez les personnes atteintes d'alopécie ou d'effluvium télogène. Par «additif technologique», on désigne toute substance chimique ou toute composition chimique dont la fonction technique est de permettre et/ou de faciliter le mélange des différents constituants de ladite composition comestible, de faciliter et/ou d'optimiser les propriétés physiques de ladite composition comestible, comme de faciliter et/ou d'optimiser son écoulement, sa stabilité, et son incorporation dans une formulation pharmaceutique et/ou nutritionnelle ultérieure, et qui sont susceptibles de respecter les conditions requises par les réglementations en vigueur pour la mise sur le marché d'une formulation pharmaceutique et/ou d'une formulation nutritionnelle. Par additif technologique pharmaceutiquement acceptable, on désigne un additif technologique dont l’utilisation répond aux exigences de la réglementation pharmaceutique en vigueur dans un pays concerné.
Selon un aspect particulier de l’invention, ledit additif technologique comestible est pharmaceutiquement acceptable est choisi parmi un agent diluant, un agent d'écoulement, un agent liant ou un agent délitant. Comme agent diluant, il y a par exemple le lactose, le sucrose, le saccharose, le glucose, la maltodextrine, le mannitol, le sorbitol, le xylitol, l'isomalt, l'hydrogénophosphate de calcium, la cellulose microcristalline, les amidons comme les amidons de maïs, de blé ou de pommes de terre, le phosphate dicalcique, les carbonates de sodium, de calcium ou de magnésium, les monoglycérides et/ou les diglycérides d'acides gras comportant de 8 à 24 atomes de carbone. Comme agent d'écoulement, il y a par exemple le stéarate de magnésium, le talc, le stéarylfumarate de sodium, les huiles végétales hydrogénées, la silice colloïdale anhydre, le benzoate de sodium ou le dioxyde de silice. Comme agent liant, il y a par exemple les amidons sous forme d'empois, les amidons prégélatinisés, l'hydroxypropylméthyl cellulose (HPMC), la méthylcellulose, les sirops de saccharose ou la gomme d'acacia. Comme agent délitant, il y a par exemple les amidons, le glycolate d'amidon sodique, l'acide alginique, I'alginate de sodium, la croscarmellose sodique, la crospovidone, ou et la polyvinylpyrrolidone. Selon un aspect particulier de l’invention, ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, comprend en outre, au moins un principe actif choisi parmi les lipides bioactifs, les sels d'oligo-éléments hydrosolubles ou hydro-dispersibles, les vitamines hydrosolubles ou liposolubles, les prébiotiques, les probiotiques, les protéines et/ou les concentrats de protéines laitières, les enzymes végétales ou animales, les acides aminés, les peptides, les sucres, les exhausteurs de goût et les agents aromatisants. Comme lipides bioactifs éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple les phytostérols, comme ceux extraits des huiles végétales, et plus particulièrement les extraits de l'huile d'argousier, de l'huile de mais ou de l'huile de soja ; les complexes de phytostérols isolés des huiles végétales, comme la cholestatine composée de campestérol, de stigmastérol et de brassicastérol ; les phytostanols ; les caroténoïdes, qui appartiennent à la famille des terpenoïdes extraits des algues, des plantes vertes, des champignons, des bactéries; les acides gras polyinsaturés du groupe omega-3, comme l'acide alpha-linoléique, l'acide eicosapentaénoïque, l'acide docosahexanoïque; les acides gras polyinsaturés du groupe omega-6, comme l'acide linoléique, l'acide g-linoléique, l'acide eicosadiénoique, l'acide dihomo-y-linoléique, l'acide
arachidonique, l'acide docosadiénoïque, l'acide docosatétraénoïque, l'acide docosapentaénoïque. Comme sels d'oligo-éléments hydrosolubles ou hydro-dispersibles éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple le carbonate ferreux, le chlorure ferreux tétrahydraté, le chlorure ferrique hexahydraté, le citrate ferreux hexahydraté, le fumarate ferreux, le lactate ferreux tétrahydraté, le sulfate ferreux monohydrate, le sulfate ferreux heptahydraté, le chélate ferreux d'acides aminés hydrates, le chélate de fer de glycine; l'iodate de calcium hexahydraté, l'iodate de calcium anhydre; l'iodure de sodium, l'iodure de potassium; l'acétate de cobalt tétrahydraté, le carbonate basique de cobalt monohydrate, le carbonate de cobalt hexahydraté, le sulfate de cobalt heptahydraté, le sulfate de cobalt monohydrate, le nitrate de cobalt hexahydraté; l'acétate cuivrique monohydrate, le carbonate basique de cuivre monohydrate, le chlorure cuivrique dihydraté, le méthionate de cuivre, le sulfate cuivrique pentahydraté, le chélate cuivreux d'acides aminés hydrates, le chélate cuivreux de glycine hydrate, le chélate de cuivre de Phydroxy-analogue de méthionine; le carbonate manganeux, le chlorure manganeux tétrahydraté, le phosphate acide de manganèse trihydraté, le sulfate manganeux tétrahydraté, le sulfate manganeux monohydraté, le chélate de manganèse d'acides aminés hydrate, le chélate de manganèse de glycine hydrate, le chélate de manganèse de l'hydroxy-analogue de méthionine; le molybdate d'ammonium, le molybdate de sodium, le sélénite de sodium, le sélénate de sodium; la forme organique du sélénium produite par saccharomyces cerevisiae, la sélénométhionine (levure séléniée inactivée), et la séléno méthionine produite par Saccharomyces cerevisiae (levure séléniée inactivée). Comme vitamines hydrosolubles ou liposolubles éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple la vitamine A, plus particulièrement sous sa forme de rétinol, d'acétate de rétinyle, de palmitate de rétinyle ou de β-carotène ; la vitamine D2, plus particulièrement sous sa forme dergocalciférol, ou de 25-hydroxy calciférol ; la vitamine D3, plus particulièrement sous sa forme de cholecalciférol ; la vitamine K, plus particulièrement sous sa forme de phylloquinone (phytoménadione) ou de Ménaquinone ; la vitamine B1, plus particulièrement sous sa forme de chlorhydrate de thiamine, de mononitrate de thiamine, de chlorure de thiamine monophosphate, ou de chlorure de thiamine pyrophosphate, la vitamine B2, plus particulièrement sous sa forme de riboflavine, de riboflavine 5'-phosphate de sodium, la vitamine B6, plus particulièrement sous sa forme de chlorhydrate de pyridoxine, de pyridoxine 5'-phosphate, ou de pyridoxal 5'-phosphate, la vitamine B12, plus particulièrement
sous sa forme de cyanocobalamine, d'hydroxocobalamine, de 5'-déoxyadenosylcobalamine, ou de méthylcobalamine, la vitamine C, plus particulièrement sous sa forme d'acide L- ascorbique, de L-ascorbate de sodium, de L-ascorbate de calcium, de L-ascorbate de potassium, de sels de calcium de l'acide palmityl-6-L-ascorbique, l’ascorbylmonophosphate de sodium, l'acide pantothénique, plus particulièrement sous sa forme de D-pantothénate de calcium, de D- pantothénate de sodium, de Dexpanthénol, ou de Pantéthine, la vitamine PP, plus particulièrement sous sa forme d'acide nicotinique, de niacine, de nicotinamide, ou d'hexanicotinate d'inositol (hexaniacinate d'inositol), la vitamine B9, plus particulièrement sous sa forme d'acide folique, les folates, plus particulièrement sous leur forme d'acide ptéroylmonoglutamique, de L-méthylfolate de calcium, d'acide (6S)-5- méthyltetrahydrofolique sous forme de sel de glucosamine, la vitamine H2, B7 ou BW, plus particulièrement sous sa forme de biotine, la choline, plus particulièrement sous sa forme de chlorure de choline, de choline dihydrogène citrate, de bitartrate de choline, l'inositol, la carnitine, plus particulièrement sous sa forme de L-carnitine, L-carnitine-L-tartrate, la taurine. Comme pré-biotiques éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple l'inuline, les trans-galacto- oligosaccharides, les fructanes et les manno-oligosaccharides. Comme probiotiques éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a différentes souches de Saccharomyces cerevisiae, de Bacillus cereus var. toyoi, de Bacillus subtilis seul ou en combinaison avec le Bacillus licheniformis, ou encore des souches d'Enteroccocus faecium. Ces souches de microorganismes sont généralement associées à un support solide, par exemple le carbonate de calcium, le dextrose ou le sorbitol. Comme protéines et/ou concentrats de protéines éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple les protéines laitières issues du lait, telles que le colostrum sous forme de poudre lyophilisée ou atomisée ou le lactosérum sous forme de poudre, de fractions purifiées ou enrichies en IgG, en lactoferrine, en lactoperoxydase. Comme enzymes végétales ou animales éventuellement présentes dans la composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple la promutase, la superoxyde dismutase (SOD), la 3-phytase, la 6-phytase, les endo-l,4-bétaglucanases, les endo-1,4-bétaxylanases, ou encore d'autres enzymes améliorant ou favorisant la digestion. Comme peptides éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple les peptides de l'avocat, les peptides de
lupin, les peptides de quinoa, les peptides de maca, les peptides de soja fermenté ou non, les peptides de riz, les peptides présents dans l'extrait de graines d'Acacia macrostachya, les peptides présents dans les extraits de graines de passiflore. Comme acides aminés éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple l'alanine, l'arginine, l'asparagine, l'acide aspartique, la cystéine, l'acide glutamique, la glutamine, la glycine, l'histidine, l'isoleucine, la leucine, la lysine, la méthionine, la phénylalanine, la proline, l'hydroxy-proline, la pyrrolysine, la selmeno-cysteine, la sérine, la thréonine, le tryptophane, la tyrosine, la valine, la sarcosine, l'ornithine. Comme sucres éventuellement présents dans ladite composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple les polysaccharides solubles dans l'eau, les sucres de poids moléculaire inferieur, tels que les oligosaccharides, mono- ou disaccharides, comme par exemple le glucose, le lactose, le dextrose. Comme exhausteurs de goût éventuellement présents dans la composition pharmaceutique comestible (Cp) telle que définie ci-dessus, il y a par exemple les glutamates, comme l'acide glutamique, le glutamate monosodique, le glutamate monopotassique, le diglutamate de calcium, le glutamate d'ammonium, le diglutamate de magnésium; les guanylates, comme par exemple l'acide guanylique (guanosine monophosphate), le guanylate disodique, le Guanylate dipotassique, le Guanylate de calcium, les inosinates, comme par exemple l'acide inosinique, l'inosinate disodique, l'inosinate dipotassique, l'inosinate de calcium, ou encore des édulcorants intenses tels que les extraits de Stevia, les Rebiaudosides. Ladite composition pharmaceutique comestible (Cp) peut présenter sous forme solide ou liquide. Selon un aspect particulier de l’invention, ladite composition pharmaceutique comestible (Cp) se présente sous la forme d'un solide, et plus particulièrement la forme d'un comprimé, d'une gélule, d'une capsule molle, d'une poudre, d'une dragée, d’une gomme de confiserie ou d'un granule. Lorsque la composition pharmaceutique comestible (Cp) tel que définie précédemment se présente sous la forme d'un comprimé, elle comprend de préférence de 50 mg à 150 mg de ladite composition (C) telle que définie précédemment, pour un comprimé de 500 mg ; lorsqu’elle se présente sous la forme d'une capsule molle, elle comprend de préférence de 120 mg à 360 mg de ladite composition (C) pour une capsule molle de 1200 mg ; lorsqu’elle se présente sous la forme d'une gélule, elle comprend de préférence de 10 mg à 30 mg de composition (C) pour une gélule de 100 mg ; lorsqu’elle se présente sous la forme d'une
poudre, elle comprend de préférence de 200 mg à 600 mg de composition (C) pour une poudre de 2000 mg. Lorsque la composition pharmaceutique comestible (Cp) se présente sous la forme d'une poudre, elle est obtenue par introduction de ses différents constituants dans un mélangeur équipé d'au moins un système mécanique d'agitation, comme par exemple des pales d'agitation plates ou de type hélice, et le mélangeur est éventuellement un mélangeur par retournement, et le mélangeur est éventuellement équipé d'un système de type émotteur. Cette opération de mélange est généralement réalisée à température ambiante, notamment entre 15°C et 30°C. Lorsque la composition pharmaceutique comestible (Cp) se présente sous la forme d'une gomme de confiserie, elle comprend de préférence de 150 mg à 450 mg de composition (C) pour une gomme de confiserie de 1,5 g. Lorsque la composition pharmaceutique comestible (Cp) se présente sous la forme d'un liquide, elle comprend de préférence de 100 mg à 300 mg de composition (C) pour une ampoule de 1 cm3. L’invention a également pour objet l’utilisation en administration par voie orale d’une quantité efficace d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique et ladite composition (C) étant un extrait de gluten de blé, pour augmenter la densité et la longueur des cheveux. L’invention a également pour objet une méthode de traitement cosmétique destinée à augmenter la densité et la longueur des cheveux, caractérisée en ce que l’on administre par voie orale, une quantité efficace d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification
d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique et ladite composition (C) étant un extrait de gluten de blé. Au sens de la présente invention, par « croissance du cheveu» ou « pousse du cheveu», on entend l’augmentation de la longueur des cheveux et/ou la repousse des cheveux se caractérisant par l’augmentation de la densité totale des cheveux, de la densité et de la proportion de cheveux en phase anagène. Au sens de la présente invention, par « quantité efficace », on désigne une quantité suffisante qui permette au consommateur d’attention moyenne, de constater visuellement la réalité de l’aspect esthétique invoqué quant à la croissance de ses propres cheveux, en particulier l’augmentation de la longueur des cheveux et/ou la repousse des cheveux. L’étude expérimentale exposée dans la suite de la présente description fait ressortir qu’une quantité comprise entre 1 mg et 250 mg, plus particulièrement entre 10 mg et 150 mg, encore plus particulièrement entre 15 mg et 100 mg, et encore plus particulièrement entre 30 mg et 70 mg de ladite composition, ingérée par jour, peut être considérée comme une quantité efficace. La présente invention a également pour objet un complément alimentaire (Ca) comprenant pour 100% massique : - Plus de 0% massique à 30% massique de ladite composition (C) telle que définie ci- dessus et - de 70% massique à moins de 100% massique d’au moins un additif technologique nutritionnellement acceptable. De préférence le complément alimentaire (Ca) tel que défini ci-dessus, comprend pour 100% massique : - plus de 0% massique et moins de 10% massique d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant
de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique et ladite composition (C) étant un extrait de gluten de blé, et - plus de 90% massique et moins de 100% massique d’au moins un additif technologique nutritionnellement acceptable. Par complément alimentaire, on entend une composition comestible dont le but est de compléter le régime alimentaire normal et qui constitue une source concentrée de nutriments ou d'autres substances ayant un effet nutritionnel ou physiologique seuls ou combinés. Le complément alimentaire permet d'éviter certaines carences ou de répondre à des besoins spécifiques dans le régime d'alimentation d'un individu, notamment lors d'un effort physique. Cette définition du « complément alimentaire » est donnée dans l'article 2 du Décret n° 2006- 352 du 26 mars 2006 de la République Française relatif aux compléments alimentaires et dans la directive 2002/46/CE du parlement européen et du conseil du 10 juin 2002. Par « additif technologique nutritionnellement acceptable », on désigne un additif technologique tel que défini ci-dessus dont l’utilisation répond aux exigences de la réglementation relative aux compléments alimentaires en vigueur dans un pays considéré. Selon un aspect particulier de l’invention, ledit additif technologique nutritionnellement acceptable est choisi parmi un agent diluant, un agent d'écoulement, un agent liant ou un agent délitant. Comme agent diluant, il y a par exemple le lactose, le sucrose, le saccharose, le glucose, la maltodextrine, le mannitol, le sorbitol, le xylitol, I'isomalt, I'hydrogénophosphate de calcium, la cellulose microcristalline, les amidons comme les amidons de maïs, de blé, ou de pommes de terre, le phosphate dicalcique, les carbonates de sodium, de calcium ou de magnésium, les monoglycérides et/ou les diglycérides d'acides gras comportant de 8 à 24 atomes de carbone. Comme l’agent d'écoulement, il y a par exemple le stéarate de magnésium, le talc, le stéarylfumarate de sodium, les huiles végétales hydrogénées, la silice colloïdale anhydre, le benzoate de sodium ou le dioxyde de silice.
Comme agent liant, il y a par exemple les amidons sous forme d'empois, les amidons prégélatinisés, l'hydroxypropylméthyl cellulose (HPMC), la méthylcellulose, les sirops de saccharose ou la gomme d'acacia. Comme agent délitant, il y a par exemple les amidons, le glycolate d'amidon sodique, l'acide alginique, l'alginate de sodium, la croscarmellose sodique, la crospovidone, ou et la polyvinylpyrrolidone. Selon un aspect particulier de l’invention, ledit complément alimentaire (Ca) tel que défini ci- dessus, comprend en outre, au moins un principe actif choisi parmi les lipides bioactifs, les sels d'oligo-éléments hydrosolubles ou hydro-dispersibles, les vitamines hydrosolubles ou liposolubles, les prébiotiques, les probiotiques, les protéines et/ou les concentrats de protéines laitières, les enzymes végétales ou animales, les acides aminés, les peptides, les sucres, les exhausteurs de goût et les agents aromatisants. Comme lipides bioactifs éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple les phytostérols, comme ceux extraits des huiles végétales, et plus particulièrement les extraits de l'huile d'argousier, de l'huile de mais, ou l'huile de soja ; les complexes de phytostérols isolés des huiles végétales, comme la cholestatine composée de campestérol, de stigmastérol et de brassicastérol ; les phytostanols ; les caroténoïdes, qui appartiennent à la famille des terpenoïdes extraits des algues, des plantes vertes, des champignons, des bactéries; les acides gras polyinsaturés du groupe omega-3, comme l'acide alpha-linoléique, l'acide eicosapentaénoïque, l'acide docosahexanoïque; les acides gras polyinsaturés du groupe omega-6, comme l'acide linoléique, l'acide g-linoléique, l'acide eicosadiénoique, l'acide dihomo-y-linoléique, l'acide arachidonique, l'acide docosadiénoïque, l'acide docosatétraénoïque, l'acide docosapentaénoïque. Comme sels d'oligo-éléments hydrosolubles ou hydro-dispersibles éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus,, il y a par exemple le carbonate ferreux, le chlorure ferreux tétrahydraté, le chlorure ferrique hexahydraté, le citrate ferreux hexahydraté, le fumarate ferreux, le lactate ferreux tétrahydraté, le sulfate ferreux monohydrate, le sulfate ferreux heptahydraté, le chélate ferreux d'acides aminés hydrates, le chélate de fer de glycine; l'iodate de calcium hexahydraté, l'iodate de calcium anhydre; l'iodure de sodium, l'iodure de potassium; l'acétate de cobalt tétrahydraté, le carbonate basique de cobalt monohydrate, le carbonate de cobalt hexahydraté, le sulfate de cobalt heptahydraté, le sulfate de cobalt monohydrate, le nitrate de cobalt hexahydraté; l'acétate cuivrique monohydraté, le carbonate basique de cuivre monohydraté, le chlorure cuivrique dihydraté, le méthionate de cuivre, le sulfate cuivrique pentahydraté, le chélate cuivreux d'acides aminés
hydrates, le chélate cuivreux de glycine hydrate, le chélate de cuivre de Phydroxy-analogue de méthionine; le carbonate manganeux, le chlorure manganeux tétrahydraté, le phosphate acide de manganèse trihydraté, le sulfate manganeux tétrahydraté, le sulfate manganeux monohydraté, le chélate de manganèse d'acides aminés hydrate, le chélate de manganèse de glycine hydrate, le chélate de manganèse de l'hydroxy-analogue de méthionine; le molybdate d'ammonium, le molybdate de sodium, le sélénite de sodium, le sélénate de sodium; la forme organique du sélénium produite par saccharomyces cerevisiae, la sélénométhionine (levure seleniée inactivée), et la séléno méthionine produite par Saccharomyces cerevisiae (levure séleniée inactivée). Comme vitamines hydrosolubles ou liposolubles éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple la vitamine A, plus particulièrement sous sa forme de rétinol, d'acétate de rétinyle, de palmitate de rétinyle ou de β-carotène ; la vitamine D2, plus particulièrement sous sa forme dergocalciférol, ou de 25- hydroxy calciférol ; la vitamine D3, plus particulièrement sous sa forme de cholecalciférol ; la vitamine K, plus particulièrement sous sa forme de phylloquinone (phytoménadione) ou de Ménaquinone ; la vitamine B1, plus particulièrement sous sa forme de chlorhydrate de thiamine, de mononitrate de thiamine, de chlorure de thiamine monophosphate, ou de chlorure de thiamine pyrophosphate, la vitamine B2, plus particulièrement sous sa forme de riboflavine, de riboflavine 5'-phosphate de sodium, la vitamine B6, plus particulièrement sous sa forme de chlorhydrate de pyridoxine, de pyridoxine 5'-phosphate, ou de pyridoxal 5'- phosphate, la vitamine B12, plus particulièrement sous sa forme de cyanocobalamine, d'hydroxocobalamine, de 5'-déoxyadenosylcobalamine, ou de méthylcobalamine, la vitamine C, plus particulièrement sous sa forme d'acide L-ascorbique, de L-ascorbate de sodium, de L- ascorbate de calcium, de L-ascorbate de potassium, de sels de calcium de l'acide palmityl-6- L-ascorbique, l’ascorbylmonophosphate de sodium, l'acide pantothénique, plus particulièrement sous sa forme de D-pantothénate de calcium, de D- pantothénate de sodium, de Dexpanthénol, ou de Pantéthine, la vitamine PP, plus particulièrement sous sa forme d'acide nicotinique, de niacine, de nicotinamide, ou d'hexanicotinate d'inositol (hexaniacinate d'inositol), la vitamine B9, plus particulièrement sous sa forme d'acide folique, les folates, plus particulièrement sous leur forme d'acide ptéroylmonoglutamique, de L-méthylfolate de calcium, d'acide (6S)-5- méthyltetrahydrofolique sous forme de sel de glucosamine, la vitamine H2, B7 ou BW, plus particulièrement sous sa forme de biotine, la choline, plus particulièrement sous sa forme de chlorure de choline, de choline dihydrogène citrate, de
bitartrate de choline, l'inositol, la carnitine, plus particulièrement sous sa forme de L-carnitine, L-carnitine-L-tartrate, la taurine. Comme pré-biotiques éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple l'inuline, les trans-galacto-oligosaccharides, les fructanes et les manno-oligosaccharides. Comme probiotiques éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a différentes souches de Saccharomyces cerevisiae, de Bacillus cereus var toyoi, de Bacillus subtilis seul ou en combinaison avec le Bacillus licheniformis, ou encore des souches d'Enteroccocus faecium. Ces souches de microorganismes sont généralement associées a un support solide, par exemple le carbonate de calcium, le dextrose ou le sorbitol. Comme protéines et/ou concentrats de protéines éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple les protéines laitières issues du lait, telles que le colostrum sous forme de poudre lyophilisée ou atomisée ou le lactosérum sous forme de poudre, de fractions purifiées ou enrichies en IgG, en lactoferrine, en lactoperoxydase. Comme enzymes végétales ou animales éventuellement présentes dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple la promutase, la superoxyde dismutase (SOD), la 3-phytase, la 6-phytase, les endo-l,4-bétaglucanases, les endo-1,4- bétaxylanases, ou encore d'autres enzymes améliorant ou favorisant la digestion. Comme peptides éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple les peptides de l'avocat, les peptides de lupin, les peptides de quinoa, les peptides de maca, les peptides de soja fermenté ou non, les peptides de riz, les peptides présents dans l'extrait de graines d'Acacia macrostachya, les peptides présents dans les extraits de graines de passiflore. Comme acides aminés éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple l'alanine, l'arginine, l'asparagine, l'acide aspartique, la cystéine, l'acide glutamique, la glutamine, la glycine, l'histidine, l'isoleucine, la leucine, la lysine, la méthionine, la phénylalanine, la proline, l'hydroxy-proline, la pyrrolysine, la selmeno-cysteine, la sérine, la thréonine, le tryptophane, la tyrosine, la valine, la sarcosine, l'ornithine. Comme sucres éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus, il y a par exemple les polysaccharides solubles dans l'eau, les sucres de poids
moléculaire inferieur, tels que les oligosaccharides, mono- ou disaccharides, comme par exemple le glucose, le lactose, le dextrose. Comme exhausteurs de goût éventuellement présents dans ledit complément alimentaire (Ca) tel que défini ci-dessus,, il y a par exemple les glutamates, comme l'acide glutamique, le glutamate monosodique, le glutamate monopotassique, le diglutamate de calcium, le glutamate d'ammonium, le diglutamate de magnésium; les guanylates, comme par exemple l'acide guanylique (guanosine monophosphate), le guanylate disodique, le Guanylate dipotassique, le Guanylate de calcium, les inosinates, comme par exemple l'acide inosinique, l'inosinate disodique, l'inosinate dipotassique, l'inosinate de calcium, ou encore des édulcorants intenses tels que les extraits de Stevia, les Rebiaudosides. Ledit complément alimentaire (Ca) peut présenter sous forme solide ou liquide. Ledit complément alimentaire (Ca) peut se présenter sous toute forme de produit alimentaire connue de l'homme du métier, comme une boisson, et plus particulièrement une boisson aqueuse, une solution, un jus de fruit, une boisson aromatisée, une boisson énergétique, une boisson alcoolisée, une boisson à base de café, une boisson à base de chocolat, une boisson à base de thé, un produit laitier, et plus particulièrement du lait, du yaourt, un dessert lacté, du yaourt à boire, un fromage, une crème glacée, une barre chocolatée, un produit céréalier, et plus particulièrement une barre de céréale, un biscuit, des céréales pour le petit déjeuner, des farines, des produits de panification, un produit de nutrition spécialisée, plus particulièrement un produit de nutrition infantile, un produit de nutrition pour préparer à l'effort physique, un produit de nutrition clinique, un substitut de repas, des confiseries, plus particulièrement des gommes à mâcher, des bonbons, des caramels, des dragées, des berlingots, des guimauves, des lokoums, des nougats, des pâtes de fruits, des réglisses. Le complément alimentaire (Ca) selon l'invention peut également se présenter sous toute forme galénique connue de l'homme du métier, comme par exemple sous la forme d'un comprimé, d'une gélule, d'une capsule molle, d'un sirop, d'une poudre, comme par exemple une poudre à libération immédiate, d'une poudre à libération différée ou d'une poudre pour boissons reconstituées, d'un liquide, d'un stick, d'un gel. Selon un aspect particulier de l’invention, ledit complément alimentaire (Ca) tel que défini ci- dessus, se présente sous la forme d'un solide, et plus particulièrement la forme d'un comprimé, d'une gélule, d'une capsule molle, d'une poudre, d'une dragée, d’une gomme de confiserie ou d'un granule. Lorsque ledit complément alimentaire (Ca) tel que défini ci-dessus, se présente sous la forme d'un comprimé, il comprend de préférence moins de 50 mg de ladite composition (C) telle que
définie précédemment, pour un comprimé de 500 mg ; lorsqu’il se présente sous la forme d'une capsule molle, il comprend de préférence moins de 120 mg de ladite composition (C) pour une capsule molle de 1200 mg ; lorsqu’il se présente sous la forme d'une gélule, il comprend de préférence moins de 10 mg de ladite composition (C) telle que définie précédemment pour une gélule de 100 mg ; lorsqu’il se présente sous la forme d'une poudre, il comprend de préférence moins de 200 mg de ladite composition (C) telle que définie précédemment pour une poudre de 2000 mg. Lorsque ledit complément alimentaire (Ca) se présente sous la forme d'une poudre, elle est obtenue par introduction de ses différents constituants dans un mélangeur équipé d'au moins un système mécanique d'agitation, comme par exemple des pales d'agitation plates ou de type hélice, et le mélangeur est éventuellement un mélangeur par retournement, et le mélangeur est éventuellement équipé d'un système de type émotteur. Cette opération de mélange est généralement réalisée à température ambiante, notamment entre 15°C et 30°C. Lorsque ledit complément alimentaire (Ca) se présente sous la forme d'une gomme de confiserie, il comprend de préférence moins de 150 mg de ladite composition (C) telle que définie précédemment pour une gomme de confiserie de 1,5 g. Lorsque le complément alimentaire (Ca) se présente sous la forme d'un liquide, il comprend de préférence moins de 100 mg de ladite composition (C) telle que définie précédemment pour une ampoule de 1 cm3. La présente invention a également pour objet l’utilisation cosmétique en administration par voie orale, du complément alimentaire (Ca) tel que défini ci-dessus, pour augmenter la densité et la longueur des cheveux. La présente invention a enfin pour objet une méthode de traitement cosmétique destinée à augmenter la densité et la longueur des cheveux, caractérisée en ce que l’on administre par voie orale, une quantité efficace du complément alimentaire (Ca) tel que défini ci-dessus. Selon un aspect particulier de l’invention, ledit complément alimentaire (Ca) tel que défini ci- dessus est administrée par voie orale à raison d’au moins 15 mg, en particulier d’au moins 30 mg, de ladite composition (C) par jour pendant au moins 4 semaines, en particulier pendant au moins 8 semaines, encore plus particulièrement pendant 12 semaines. Les exemples suivants illustrent l'invention, sans toutefois la limiter. Formulations comparatives On utilise un extrait de gluten de blé commercial sous la forme d’une composition (C) pulvérulente qui comprend pour 100% de sa masse : 52,5% massique de sphingolipides, 41,5% massique de DigalactosylDiacylGlycérol et 6% massique de phospholipides.
Deux formulations ont été préparées, respectivement un complément alimentaire (Ca) (comprenant la composition (C)) et un complément alimentaire (C’a) (ne comprenant pas la composition (C)), qui comprennent les ingrédients comme indiqué dans le Tableau 1 : [Tableau 1] Quantité par gélule Composants Complément alimentaire (Ca) Complément alimentaire (C’a) Composition (C) 15 mg - Maltodextrine 230 mg 245 mg Phosphate bicalcique 100 mg 100 mg Carbonate de magnésium 50 mg 50 mg Silice 30 mg 30 mg Stéarate de magnésium 10 mg 10 mg Poids net total 435 mg 435 mg Poids total 549 mg 549 mg (avec poids de la gélule) 5 Mode opératoire L’effet technique de la composition (C) a été mis en évidence dans une étude clinique pilote, randomisée, en double aveugle, en groupes parallèles. Elle a permis de tester l’effet de la consommation journalière de 30 mg de (C) versus Placebo sur une période de 84 jours (12 semaines). 10 Des femmes d’ethnie caucasienne âgées entre 18 et 65 ans, présentant un effluvium télogène (proportion de cheveux en phase télogène > 15%) et se plaignant de cheveux fins et cassants, ainsi qu’un taux de sébum supérieur ou égal à 140 µg/cm², ont été incluses dans l’étude. Elles ont consommé pendant 84 jours (de J0 à J84) soit 2 gélules par jour du complément
alimentaire (Ca) soit 2 gélules par jour du complément alimentaire (C’a). Les mesures ont été effectuées à jour 0 (J0) et 56 (J56) et 84 jours (J84). A.1- La longueur des cheveux : Principe de la méthode d’évaluation La croissance des cheveux a été évaluée par la mesure de la longueur de 5 cheveux après 84 jours de supplémentation, suite à leur rasage à J0. L’amélioration de la croissance des cheveux a également été mise en évidence par les sujets de l’étude, grâce à l’utilisation d’un formulaire d’auto-évaluation. Résultats Les résultats obtenus sont présentés dans le tableau 2. [Tableau 2] Complément alimentaire (C’a) Complément alimentaire (Ca) (nombre de sujets = 32) (nombre de sujets = 33) Moyenne ± ETM Moyenne ± ETM (p vs placebo) J84 3,2 ± 0,1 3,6 ± 0,1 (p=0,0001) ETM : erreur-type de la mesure Observations - Commentaires Par mesure de la croissance des cheveux à J84 après rasage à J0, une augmentation significative de la longueur des cheveux a été observée entre le groupe complément alimentaire (Ca) (contenant la composition (C)) et le groupe complément alimentaire (C’a) (3,6 ± 0,1 cm vs 3,2 ± 0,1 cm; p<0,001). De plus, après exploitation des réponses du formulaire qualitatif, une proportion de 91% des sujets dans le groupe complément alimentaire (Ca) ont rapporté que leur “cheveux poussaient plus vite”, contre 72% des sujets dans le groupe complément alimentaire (C’a). A.2- La repousse des cheveux : Principe de la méthode d’évaluation La repousse des cheveux a été évaluée par la réalisation d’un phototrichogramme, permettant de quantifier la densité et la proportion de cheveux en phases anagène et télogène. Pour rappel, le phototrichogramme est réalisé sur une zone fixe du cuir chevelu d’un diamètre de 1,8 cm (région fronto-temporale ou vertex). Les cheveux y sont rasés, avant coloration de la zone et prise d’une première macrophotographie permettant le comptage des cheveux totaux;
une deuxième macrophotographie faite 48 heures plus tard permet ensuite de différencier les cheveux anagènes ayant poussé des cheveux télogènes n'ayant pas poussé. La densité capillaire totale est évaluée par le nombre total de poils par cm². La densité capillaire anagène est évaluée par le nombre de poils en phase anagène (ayant poussé pendant les 48 heures entre les 2 macrophotographies) par cm² et proportion (%) par rapport à la densité capillaire totale. La repousse des cheveux a également été analysée au travers d’une évaluation clinique réalisée par un dermatologue ainsi qu’à l’aide d’un formulaire d’auto-évaluation complété par les sujets de l’étude. A.2.1- Densité de cheveux en phase anagène : Résultats Les résultats obtenus sont présentés dans le tableau 3. [Tableau 3] Complément alimentaire C’a Complément alimentaire Ca (nombre de sujets = 32) (nombre de sujets = 33) Moyenne ± ETM Moyenne ± ETM % vs J0 % vs J0 (p vs J0) (p vs J0) (p vs placebo) J0 162,6 ± 4,9 - 165,5 ± 3,8 - 173,0 ± 4,2 +4,6% J56 162,8 ± 6,1 -0,13% (p=0,0005) (p=0,043) 170,8 ± 4,9 184,6 ± 4,1 +11,9% J84 +5,6% (p=0,004) (p=0,0001) (p=0,004) ETM : erreur-type de la mesure Observations - Commentaires Une augmentation significative de la densité de cheveux en phase anagène a été observée dans le groupe complément alimentaire (Ca) dès 56 jours de consommation : de 165,5 ± 3,8 cheveux/cm² à J0 à 173,0 ± 4,2 cheveux/cm² à J56 (p=0,0005) et 184,6 ± 4,1 cheveux/cm² à J84 (p=0,0001), alors qu’une augmentation significative n’a été observée dans le groupe complément alimentaire (C’a) qu’après 84 jours de consommation : de 162,6 ± 4,9 cheveux/cm² à J0 à 162,8 ± 6,1 cheveux/cm² à J56 et 170,8 ± 4,9 cheveux/cm² à J84 (p=0,004).
De plus, il y a une différence significative entre le groupe complément alimentaire (Ca) et le groupe complément alimentaire (C’a) à J56 (+4,6% vs -0,13%; p=0,043) ainsi qu’à J84 (+11,9% vs +5,6%; p=0,004). A.2.2- La proportion de cheveux en phase anagène : Résultats Les résultats obtenus sont présentés dans le tableau 4. [Tableau 4] Complément alimentaire (C’a) Complément alimentaire (Ca) (nombre de sujets = 32) (nombre de sujets = 33) Moyenne ± ETM Moyenne ± ETM % vs J0 % vs J0 (p vs J0) (p vs J0) (p vs placebo) J0 81,2 ± 0,5 - 80,9 ± 0,6 - 84,4 ± 0,6 +4,3% J56 82,3 ± 0,8 +1,3% (p=0,0001) (p=0,003) 83,2 ± 0,6 86,0 ± 0,6 +6,5% J84 +2,5% (p=0,002) (p=0,0001) (p=0,0001) ETM : erreur-type de la mesure Observations - Commentaires Une augmentation significative de la proportion de cheveux en phase anagène a été observée dans le groupe complément alimentaire (Ca) dès 56 jours de consommation : de 80,9 ± 0,6% à J0 à 84,4 ± 0,6% à J56 (p=0,0001) et 86,0 ± 0,6% à J84 (p=0,0001), alors qu’une augmentation significative a été observée dans le groupe complément alimentaire (C’a) seulement après 84 jours de consommation : de 81,2 ± 0,5% à J0 à 82,3 ± 0,8% à J56 et 83,2 ± 0,6% à J84 (p=0,002). De plus, il y a une différence significative entre le groupe complément alimentaire (Ca) et le groupe complément alimentaire (C’a) à J56 (+4,3% vs +1,3%; p=0,003) et J84 (+6.5% vs +2.5%; p=0.0001). A.2.3- La densité totale de cheveux : Résultats Les résultats obtenus sont présentés dans le tableau 5.
[Tableau 5] Complément alimentaire (C’a) Complément alimentaire (Ca) (nombre de sujets = 32) (nombre de sujets = 33) Moyenne ± ETM Moyenne ± ETM % vs D0 % vs J0 (p vs J0) (p vs J0) (p vs placebo) J0 200,5 ± 6,3 - 205,1 ± 5,1 - J56 197,7 ± 7,0 -1,5% 205,3 ± 5,1 +0,2% 214,9 ± 5,0 J84 205,4 ± 6,0 +2,9% +5.1% (p=0,0001) ETM : erreur-type de la mesure Observations - Commentaires Une augmentation significative de la densité totale de cheveux a été observée dans le groupe complément alimentaire (Ca) après 84 jours de consommation : de 205,1 ± 5,1 cheveux/cm² à J0 à 214,9 ± 5,0 cheveux/cm² à J84 (p=0,0001), alors qu’il n’y a pas eu de changement significatif dans le groupe complément alimentaire (C’a) : de 200,5 ± 6,3 cheveux/cm² à J0 à 205,4 ± 6,0 cheveux/cm² à J84. Une augmentation de la densité totale de cheveux a également été relevée par l’évaluation clinique (réalisée par un dermatologue) chez 61% des sujets dans le groupe complément alimentaire (Ca) à J56 (vs 47% des sujets dans le groupe complément alimentaire (C’a), et chez 64% des sujets dans le groupe complément alimentaire (Ca) à J84 (vs 53% des sujets dans le groupe complément alimentaire (C’a). Cette augmentation a également été mise en évidence par les sujets de l’étude, avec 85% des sujets dans le groupe complément alimentaire (Ca) ayant rapporté que leur “scalp était plus couvert”, contre 75% des sujets du groupe complément alimentaire (C’a). A.3 Conclusions Au travers de l’étude clinique, la composition (C) a démontré son activité pour favoriser la croissance des cheveux, grâce à son effet sur l’augmentation de la longueur des cheveux, et à son effet sur la densité en phase anagène et sur la densité totale. Exemples de formulations illustratives
[Tableau 6] Formule pour gélules de l’étude clinique Composant Quantité par gélule Composition (C) 15 mg Maltodextrine 230 mg Phosphate bicalcique 100 mg Carbonate de magnésium 50 mg Silice 30 mg Stéarate de magnésium 10 mg [Tableau 7] Formule pour gélules Composant Quantité par gélule Composition (C) 30 mg Maltodextrine 220 mg Jus de betterave 70 mg Stéarate de magnésium 15 mg 5
PHARMACEUTICAL OR COSMETIC COMPOSITION FOR PROMOTING HAIR GROWTH The invention relates to the field of cosmetics and pharmacy. It concerns the treatment for promoting hair growth. The hair fiber consists of a visible shaft, a hair bulb, located under the surface of the scalp, and a dermal papilla located at the base of the bulb. The shaft is made up of three concentric layers: the medulla, the cortex and the cuticle. The medulla is the central part, while the cortex is the intermediate layer and constitutes the body of the hair. The cortex is composed of long chains of keratin which give the hair its elasticity, flexibility and resistance. The hair fiber is protected by the cuticle, formed by keratin scales sealed to each other by an intercellular cement rich in lipids and in particular ceramides. These lipid substances ensure the barrier function of the hair by giving it a certain impermeability. At its base, the shaft is surrounded by two sheaths: the outer epithelial sheath, which has a composition similar to the epidermis, and the inner epithelial sheath, rich in glycoproteins, constituting the nourishing base of the developing hair. The hair bulb is composed of keratinocytes whose active division is responsible for the formation of the hair shaft, as well as the inner and outer epithelial sheaths. The dermal papilla is a highly vascularized area and is the site of the cell multiplication necessary for hair growth. It is composed of fibroblasts and provides nutrition, irrigation, oxygenation and the elimination of cellular waste from the hair. Hair grows according to a growth cycle composed of three successive phases: the anagen phase (growth phase), the catagen phase (regression phase) and the telogen phase (resting phase). The anagen phase is a growth phase, lasting on average 2 to 4 years in men and up to 6 years in women. This phase is characterized by rapid proliferation and differentiation of keratinocytes to form the hair and epithelial sheaths. The intense metabolic activity at the bulb level leads to the formation of keratin, a protein essential to the composition of hair. Under normal conditions, approximately 85% of the hair is in the anagen phase. The catagen phase is a regression phase, lasting a short time of two to three weeks, constituting the transition phase between the growth phase and the resting phase. This phase is characterized by the involution of the hair follicle by a phenomenon of programmed death. Cell differentiation decreases until it stops. The volume of the bulb decreases, the latter rises towards the surface of the epidermis until it causes the physical link with the dermal papilla to break. This phase concerns approximately 1% of the hair. The telogen phase is a resting phase preceding hair loss, lasting an average of two to three months. This phase is characterized by an absence of cell proliferation. The dead hair remains attached to the hair follicle, and falls out when it is pushed back by a new hair, for which a new anagen phase begins. This phase concerns approximately 10 to 15% of the hair. Under the influence of different factors, this hair cycle can be altered. In particular, stress, fatigue, pollution, hormonal imbalance or drug treatment can cause abundant and non-localized hair loss, called telogen effluvium. In this case, the proportion of hair in the telogen phase increases, which can be greater than 20%. This is called telogen effluvium. This disorder generally lasts between two and four months and is accompanied by a weakening of the hair structure. The proportion of hair in the anagen and telogen phases can be assessed by performing a phototrichogram, a standardized method measuring the fundamental parameters related to hair growth. The phototrichogram is performed on a fixed area of the scalp with a diameter of 1.8 cm (frontotemporal region or vertex). The hair is shaved before an initial macrophotograph to count the total hair; a second macrophotograph taken 48 hours later then makes it possible to differentiate the anagen hair that has grown from the telogen hair that has not grown. As part of their research aimed at developing the use of natural compounds in therapy and cosmetics, the inventors have demonstrated that the use of a composition derived from wheat gluten extracts, administered orally, is capable of promoting hair growth (or growth), particularly in people suffering from alopecia or telogen effluvium. According to a first aspect, the invention thus relates to a composition (C) characterized in that it is a wheat gluten extract, comprising for 100% by mass: - from 20% by mass to 80% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass of at least one phospholipid (a3), and in that the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), is equal to 100% by mass, for its oral use, in a therapeutic treatment method for promoting hair growth and more particularly for increasing the density and length of hair. For the purposes of the present invention, the term "sphingolipids" means complex lipids resulting from the amidation of a fatty acid on sphingosine. Sphingosine is an amido-diol having an ethylenic double bond; called 2-amino-octadec-4-ene-1,3-diol and of formula (I): a sub-monoester group or and phosphoethanolamines, phosphatidylinositol, lysophosphatidylethanolamines, phosphatidic acids, phosphatidylcholine and lysophosphatidylcholines. According to a first particular aspect, the composition (C) as defined above comprises for 100% by mass from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine. According to a second particular aspect, the composition (C) as defined above comprises for 100% by mass from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2). According to a third particular aspect, the composition (C) as defined above comprises for 100% by mass from 1% by mass to 10% by mass, of at least one phospholipid (a3). The invention more particularly relates to a composition (C) comprising for 100% by mass: - from 20% by mass to 60% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 19% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 10% by mass of at least one phospholipid (a3) for its oral use, in a therapeutic treatment method for increasing the density and length of hair. According to another particular aspect of the invention, the composition (C) as defined above is in oily form or in powder form. Said composition (C) as defined above is prepared by methods known to those skilled in the art and more particularly that described in the international patent application published under number WO 99/65459, on pages 8 to 11. It is more particularly prepared according to a process comprising the following successive steps: - At least one step a) of providing wheat gluten flour, - At least one step b) of adding the wheat gluten flour to ethanol (97% minimum) with mechanical stirring for a period of at least two hours and at a temperature of 60°C, - At least one step c) of spinning followed by a sub-step of decanting the mixture obtained in step b) so as to recover a homogeneous liquid phase, - At least one step d) of vacuum distillation of the liquid obtained during step c), at a temperature less than or equal to 35°C to remove the ethanol so as to obtain a concentrated composition, - At least one step e) of adding the product obtained at the end of step d) to ethanol, with mechanical stirring and at a temperature of 4°C, so as to precipitate the medium and recover the liquid part, - At least one step f) of distilling the liquid obtained at the end of step e) to remove the ethanol and obtain an oily composition, - At least one step g) of adding composition (C) to acetone so as to obtain a precipitate, - At least one step h) of filtering the medium obtained at the end of step g) to recover a powdery solid, - drying the solid cake obtained at the end of step g) to obtain a composition in powder form. The present invention also relates to an edible pharmaceutical composition (Cp) comprising for 100% by mass: - more than 0% by mass to 30% by mass of said composition (C) as defined above and - from 70% by mass to less than 100% by mass of at least one pharmaceutically acceptable edible technological additive, for its oral use, in a therapeutic treatment method for increasing the density and length of hair. Preferably, said edible pharmaceutical composition (Cp) comprises for 100% by mass: - from 10% by mass to 30% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass, and said composition (C) being a wheat gluten extract, and - from 70% by mass to 90% by mass of at least one pharmaceutically acceptable edible technological additive, for its oral use, in a therapeutic treatment method for increasing the density and length of hair, more particularly in people suffering from alopecia or telogen effluvium. "Technological additive" means any chemical substance or chemical composition whose technical function is to enable and/or facilitate the mixing of the various constituents of said edible composition, to facilitate and/or optimize the physical properties of said edible composition, as well as to facilitate and/or optimize its flow, stability, and incorporation into a subsequent pharmaceutical and/or nutritional formulation, and which are capable of complying with the conditions required by the regulations in force for the placing on the market of a pharmaceutical formulation and/or a nutritional formulation. A pharmaceutically acceptable technological additive means a technological additive whose use meets the requirements of the pharmaceutical regulations in force in a country concerned. According to a particular aspect of the invention, said pharmaceutically acceptable edible technological additive is selected from a diluting agent, a flow agent, a binding agent or a disintegrating agent. As diluting agent, there are for example lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomalt, calcium hydrogen phosphate, microcrystalline cellulose, starches such as corn, wheat or potato starches, dicalcium phosphate, sodium, calcium or magnesium carbonates, monoglycerides and/or diglycerides of fatty acids comprising from 8 to 24 carbon atoms. Examples of flow agents include magnesium stearate, talc, sodium stearyl fumarate, hydrogenated vegetable oils, colloidal anhydrous silica, sodium benzoate or silicon dioxide. Examples of binding agents include starches in the form of starch, pregelatinized starches, hydroxypropylmethyl cellulose (HPMC), methylcellulose, sucrose syrups or gum acacia. Examples of disintegrating agents include starches, sodium starch glycolate, alginic acid, sodium alginate, croscarmellose sodium, crospovidone or polyvinylpyrrolidone. According to a particular aspect of the invention, said edible pharmaceutical composition (Cp) as defined above, further comprises at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents. As bioactive lipids possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example phytosterols, such as those extracted from vegetable oils, and more particularly extracts of sea buckthorn oil, corn oil or soybean oil; phytosterol complexes isolated from vegetable oils, such as cholestatin composed of campesterol, stigmasterol and brassicasterol; phytostanols; carotenoids, which belong to the family of terpenoids extracted from algae, green plants, fungi, bacteria; polyunsaturated fatty acids of the omega-3 group, such as alpha-linoleic acid, eicosapentaenoic acid, docosahexaenoic acid; polyunsaturated fatty acids of the omega-6 group, such as linoleic acid, g-linoleic acid, eicosadienoic acid, dihomo-y-linoleic acid, arachidonic acid, docosadienoic acid, docosatetraenoic acid, docosapentaenoic acid. As salts of water-soluble or water-dispersible trace elements possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example ferrous carbonate, ferrous chloride tetrahydrate, ferric chloride hexahydrate, ferrous citrate hexahydrate, ferrous fumarate, ferrous lactate tetrahydrate, ferrous sulfate monohydrate, ferrous sulfate heptahydrate, ferrous chelate of amino acids hydrates, iron chelate of glycine; calcium iodate hexahydrate, anhydrous calcium iodate; sodium iodide, potassium iodide; cobalt acetate tetrahydrate, basic cobalt carbonate monohydrate, cobalt carbonate hexahydrate, cobalt sulfate heptahydrate, cobalt sulfate monohydrate, cobalt nitrate hexahydrate; cupric acetate monohydrate, basic copper carbonate monohydrate, cupric chloride dihydrate, copper methionate, cupric sulfate pentahydrate, cuprous chelate of amino acids hydrates, cuprous chelate of glycine hydrate, copper chelate of hydroxy analogue of methionine; manganous carbonate, manganous chloride tetrahydrate, manganese acid phosphate trihydrate, manganous sulfate tetrahydrate, manganous sulfate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of glycine hydrate, manganese chelate of hydroxy analogue of methionine; ammonium molybdate, sodium molybdate, sodium selenite, sodium selenate; the organic form of selenium produced by saccharomyces cerevisiae, selenomethionine (inactivated selenium yeast), and seleno methionine produced by Saccharomyces cerevisiae (inactivated selenium yeast). As water-soluble or fat-soluble vitamins possibly present in said edible pharmaceutical composition (Cp) as defined above, there is for example vitamin A, more particularly in its form of retinol, retinyl acetate, retinyl palmitate or β-carotene; vitamin D2, more particularly in its form of dergocalciferol, or 25-hydroxy calciferol; vitamin D3, more particularly in its form of cholecalciferol; vitamin K, more particularly in its form of phylloquinone (phytomenadione) or menaquinone; vitamin B1, more particularly in its form of thiamine hydrochloride, thiamine mononitrate, thiamine chloride monophosphate, or thiamine chloride pyrophosphate, vitamin B2, more particularly in its form of riboflavin, sodium riboflavin 5'-phosphate, vitamin B6, more particularly in its form of pyridoxine hydrochloride, pyridoxine 5'-phosphate, or pyridoxal 5'-phosphate, vitamin B12, more particularly in its form of cyanocobalamin, hydroxocobalamin, 5'-deoxyadenosylcobalamin, or methylcobalamin, vitamin C, more particularly in its form of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, calcium salts of palmityl-6-L-ascorbic acid, sodium ascorbyl monophosphate, pantothenic acid, more particularly in its form of calcium D-pantothenate, sodium D-pantothenate, Dexpanthenol, or Pantethine, vitamin PP, more particularly in its form of nicotinic acid, niacin, nicotinamide, or inositol hexanicotinate (inositol hexaniacinate), vitamin B9, more particularly in its form of folic acid, folates, more particularly in their form of pteroylmonoglutamic acid, calcium L-methylfolate, (6S)-5-methyltetrahydrofolic acid in the form of glucosamine salt, vitamin H2, B7 or BW, more particularly in its form of biotin, choline, more particularly in its form of choline chloride, choline dihydrogen citrate, choline bitartrate, inositol, carnitine, more particularly in its form of L-carnitine, L-carnitine-L-tartrate, taurine. As prebiotics possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example inulin, trans-galacto-oligosaccharides, fructans and manno-oligosaccharides. As probiotics possibly present in said edible pharmaceutical composition (Cp) as defined above, there are different strains of Saccharomyces cerevisiae, Bacillus cereus var. toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or strains of Enteroccocus faecium. These strains of microorganisms are generally associated with a solid support, for example calcium carbonate, dextrose or sorbitol. As proteins and/or protein concentrates possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example milk proteins derived from milk, such as colostrum in the form of freeze-dried or atomized powder or whey in the form of powder, purified fractions or enriched with IgG, lactoferrin, lactoperoxidase. As plant or animal enzymes possibly present in the edible pharmaceutical composition (Cp) as defined above, there are for example promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-betaglucanases, endo-1,4-betaxylanases, or other enzymes improving or promoting digestion. As peptides possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example avocado peptides, lupin, quinoa peptides, maca peptides, fermented or unfermented soybean peptides, rice peptides, peptides present in Acacia macrostachya seed extract, peptides present in passionflower seed extracts. As amino acids possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxy-proline, pyrrolysine, selmeno-cysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, ornithine. As sugars possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example water-soluble polysaccharides, sugars of lower molecular weight, such as oligosaccharides, mono- or disaccharides, such as for example glucose, lactose, dextrose. As flavor enhancers possibly present in the edible pharmaceutical composition (Cp) as defined above, there are for example glutamates, such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, magnesium diglutamate; guanylates, such as for example guanylic acid (guanosine monophosphate), disodium guanylate, dipotassium guanylate, calcium guanylate, inosinates, such as for example inosinic acid, disodium inosinate, dipotassium inosinate, calcium inosinate, or intense sweeteners such as Stevia extracts, Rebiaudosides. Said edible pharmaceutical composition (Cp) may be in solid or liquid form. According to a particular aspect of the invention, said edible pharmaceutical composition (Cp) is in the form of a solid, and more particularly the form of a tablet, a capsule, a soft capsule, a powder, a dragée, a confectionery gum or a granule. When the edible pharmaceutical composition (Cp) as defined above is in the form of a tablet, it preferably comprises from 50 mg to 150 mg of said composition (C) as defined above, for a 500 mg tablet; when it is in the form of a soft capsule, it preferably comprises from 120 mg to 360 mg of said composition (C) for a 1200 mg soft capsule; when it is in the form of a gelatin capsule, it preferably comprises from 10 mg to 30 mg of composition (C) for a 100 mg gelatin capsule; when it is in the form of a powder, it preferably comprises from 200 mg to 600 mg of composition (C) for a powder of 2000 mg. When the edible pharmaceutical composition (Cp) is in the form of a powder, it is obtained by introducing its various constituents into a mixer equipped with at least one mechanical stirring system, such as for example flat or propeller-type stirring blades, and the mixer is optionally a turning mixer, and the mixer is optionally equipped with a lump-forming system. This mixing operation is generally carried out at room temperature, in particular between 15°C and 30°C. When the edible pharmaceutical composition (Cp) is in the form of a confectionery gum, it preferably comprises from 150 mg to 450 mg of composition (C) for a confectionery gum of 1.5 g. When the edible pharmaceutical composition (Cp) is in the form of a liquid, it preferably comprises from 100 mg to 300 mg of composition (C) for a 1 cm3 ampoule. The invention also relates to the use in oral administration of an effective amount of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, for increasing the density and length of the hair. The invention also relates to a cosmetic treatment method intended to increase the density and length of the hair, characterized in that an effective amount of a composition (C) comprising for 100% by mass is administered orally: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract. For the purposes of the present invention, "hair growth" or "hair growth" means the increase in hair length and/or hair regrowth characterized by an increase in the total density of the hair, the density and the proportion of hair in the anagen phase. For the purposes of the present invention, "effective amount" means a sufficient amount that allows the consumer of average attention to visually observe the reality of the aesthetic aspect invoked with regard to the growth of his or her own hair, in particular the increase in hair length and/or hair regrowth. The experimental study set out in the remainder of the present description shows that an amount of between 1 mg and 250 mg, more particularly between 10 mg and 150 mg, even more particularly between 15 mg and 100 mg, and even more particularly between 30 mg and 70 mg of said composition, ingested per day, can be considered an effective amount. The present invention also relates to a food supplement (Ca) comprising for 100% by mass: - More than 0% by mass to 30% by mass of said composition (C) as defined above and - from 70% by mass to less than 100% by mass of at least one nutritionally acceptable technological additive. Preferably, the food supplement (Ca) as defined above comprises for 100% by mass: - more than 0% by mass and less than 10% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting of the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, and - more than 90% by mass and less than 100% by mass of at least one nutritionally acceptable technological additive. A dietary supplement is an edible composition whose purpose is to supplement the normal diet and which constitutes a concentrated source of nutrients or other substances having a nutritional or physiological effect alone or in combination. A dietary supplement helps to avoid certain deficiencies or to meet specific needs in an individual's diet, particularly during physical exertion. This definition of "dietary supplement" is given in Article 2 of Decree No. 2006-352 of March 26, 2006 of the French Republic relating to food supplements and in Directive 2002/46/EC of the European Parliament and of the Council of June 10, 2002. A "nutritionally acceptable technological additive" means a technological additive as defined above, the use of which meets the requirements of the regulations relating to food supplements in force in a given country. According to a particular aspect of the invention, said nutritionally acceptable technological additive is chosen from a diluting agent, a flow agent, a binding agent or a disintegrating agent. As diluting agent, there are for example lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomalt, calcium hydrogen phosphate, microcrystalline cellulose, starches such as corn, wheat or potato starches, dicalcium phosphate, sodium, calcium or magnesium carbonates, monoglycerides and/or diglycerides of fatty acids comprising from 8 to 24 carbon atoms. Examples of flow agents include magnesium stearate, talc, sodium stearyl fumarate, hydrogenated vegetable oils, colloidal anhydrous silica, sodium benzoate or silicon dioxide. As binding agents, there are for example starches in the form of starch, pregelatinized starches, hydroxypropylmethyl cellulose (HPMC), methylcellulose, sucrose syrups or gum acacia. As disintegrating agents, there are for example starches, sodium starch glycolate, alginic acid, sodium alginate, croscarmellose sodium, crospovidone, or polyvinylpyrrolidone. According to a particular aspect of the invention, said food supplement (Ca) as defined above, further comprises at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents. As bioactive lipids possibly present in said food supplement (Ca) as defined above, there are for example phytosterols, such as those extracted from vegetable oils, and more particularly extracts of sea buckthorn oil, corn oil, or soybean oil; phytosterol complexes isolated from vegetable oils, such as cholestatin composed of campesterol, stigmasterol and brassicasterol; phytostanols; carotenoids, which belong to the family of terpenoids extracted from algae, green plants, fungi, bacteria; polyunsaturated fatty acids of the omega-3 group, such as alpha-linoleic acid, eicosapentaenoic acid, docosahexaenoic acid; polyunsaturated fatty acids of the omega-6 group, such as linoleic acid, g-linoleic acid, eicosadienoic acid, dihomo-y-linoleic acid, arachidonic acid, docosadienoic acid, docosatetraenoic acid, docosapentaenoic acid. As salts of water-soluble or water-dispersible trace elements possibly present in said food supplement (Ca) as defined above, there are for example ferrous carbonate, ferrous chloride tetrahydrate, ferric chloride hexahydrate, ferrous citrate hexahydrate, ferrous fumarate, ferrous lactate tetrahydrate, ferrous sulfate monohydrate, ferrous sulfate heptahydrate, ferrous chelate of amino acids hydrates, iron chelate of glycine; calcium iodate hexahydrate, anhydrous calcium iodate; sodium iodide, potassium iodide; cobalt acetate tetrahydrate, basic cobalt carbonate monohydrate, cobalt carbonate hexahydrate, cobalt sulfate heptahydrate, cobalt sulfate monohydrate, cobalt nitrate hexahydrate; cupric acetate monohydrate, basic copper carbonate monohydrate, cupric chloride dihydrate, cupric methionate, cupric sulfate pentahydrate, cuprous chelate of amino acids hydrates, cuprous chelate of glycine hydrate, copper chelate of hydroxy analogue of methionine; manganous carbonate, manganous chloride tetrahydrate, manganese acid phosphate trihydrate, manganous sulfate tetrahydrate, manganese sulfate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of glycine hydrate, manganese chelate of hydroxy analogue of methionine; ammonium molybdate, sodium molybdate, sodium selenite, sodium selenate; the organic form of selenium produced by saccharomyces cerevisiae, selenomethionine (inactivated selenium yeast), and selenomethionine produced by Saccharomyces cerevisiae (inactivated selenium yeast). As water-soluble or fat-soluble vitamins possibly present in said food supplement (Ca) as defined above, there is for example vitamin A, more particularly in its form of retinol, retinyl acetate, retinyl palmitate or β-carotene; vitamin D2, more particularly in its form of dergocalciferol, or 25-hydroxy calciferol; vitamin D3, more particularly in its form of cholecalciferol; vitamin K, more particularly in its form of phylloquinone (phytomenadione) or Menaquinone; vitamin B1, more particularly in its form of thiamine hydrochloride, thiamine mononitrate, thiamine chloride monophosphate, or thiamine chloride pyrophosphate, vitamin B2, more particularly in its form of riboflavin, sodium riboflavin 5'-phosphate, vitamin B6, more particularly in its form of pyridoxine hydrochloride, pyridoxine 5'-phosphate, or pyridoxal 5'-phosphate, vitamin B12, more particularly in its form of cyanocobalamin, hydroxocobalamin, 5'-deoxyadenosylcobalamin, or methylcobalamin, vitamin C, more particularly in its form of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, calcium salts of palmityl-6- L-ascorbic acid, sodium ascorbyl monophosphate, pantothenic acid, more particularly in its form of calcium D-pantothenate, sodium D-pantothenate, Dexpanthenol, or Pantethine, vitamin PP, more particularly in its form of nicotinic acid, niacin, nicotinamide, or inositol hexanicotinate (inositol hexaniacinate), vitamin B9, more particularly in its form of folic acid, folates, more particularly in their form of pteroylmonoglutamic acid, calcium L-methylfolate, (6S)-5-methyltetrahydrofolic acid in the form of glucosamine salt, vitamin H2, B7 or BW, more particularly in its form of biotin, choline, more particularly in its form of choline chloride, choline dihydrogen citrate, choline bitartrate, inositol, carnitine, more particularly in its form of L-carnitine, L-carnitine-L-tartrate, taurine. As prebiotics possibly present in said food supplement (Ca) as defined above, there are for example inulin, trans-galacto-oligosaccharides, fructans and manno-oligosaccharides. As probiotics possibly present in said food supplement (Ca) as defined above, there are different strains of Saccharomyces cerevisiae, Bacillus cereus var toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or strains of Enteroccocus faecium. These strains of microorganisms are generally associated with a solid support, for example calcium carbonate, dextrose or sorbitol. As proteins and/or protein concentrates possibly present in said food supplement (Ca) as defined above, there are for example milk proteins from milk, such as colostrum in the form of freeze-dried or atomized powder or whey in the form of powder, purified fractions or enriched with IgG, lactoferrin, lactoperoxidase. As plant or animal enzymes possibly present in said food supplement (Ca) as defined above, there are for example promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-betaglucanases, endo-1,4-betaxylanases, or other enzymes improving or promoting digestion. As peptides possibly present in said food supplement (Ca) as defined above, there are for example avocado peptides, lupin peptides, quinoa peptides, maca peptides, fermented or non-fermented soy peptides, rice peptides, peptides present in Acacia macrostachya seed extract, peptides present in passionflower seed extracts. As amino acids possibly present in said food supplement (Ca) as defined above, there are for example alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxy-proline, pyrrolysine, selmeno-cysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, ornithine. As sugars possibly present in said food supplement (Ca) as defined above, there are for example water-soluble polysaccharides, sugars of weight lower molecular weight, such as oligosaccharides, mono- or disaccharides, such as glucose, lactose, dextrose. As flavor enhancers possibly present in said food supplement (Ca) as defined above, there are for example glutamates, such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, magnesium diglutamate; guanylates, such as guanylic acid (guanosine monophosphate), disodium guanylate, dipotassium guanylate, calcium guanylate, inosinates, such as inosinic acid, disodium inosinate, dipotassium inosinate, calcium inosinate, or intense sweeteners such as Stevia extracts, Rebiaudosides. Said food supplement (Ca) can be in solid or liquid form. Said food supplement (Ca) may be in any form of food product known to those skilled in the art, such as a drink, and more particularly an aqueous drink, a solution, a fruit juice, a flavored drink, an energy drink, an alcoholic drink, a coffee-based drink, a chocolate-based drink, a tea-based drink, a dairy product, and more particularly milk, yogurt, a dairy dessert, drinkable yogurt, cheese, ice cream, a chocolate bar, a cereal product, and more particularly a cereal bar, a biscuit, breakfast cereals, flours, bakery products, a specialized nutrition product, more particularly an infant nutrition product, a nutrition product to prepare for physical exercise, a clinical nutrition product, a meal replacement, confectionery, more particularly chewing gum, sweets, caramels, sugared almonds, berlingots, marshmallows, lokoums, nougats, fruit pastes, liquorice. The food supplement (Ca) according to the invention may also be in any galenic form known to those skilled in the art, such as for example in the form of a tablet, a capsule, a soft capsule, a syrup, a powder, such as for example an immediate-release powder, a delayed-release powder or a powder for reconstituted drinks, a liquid, a stick, a gel. According to a particular aspect of the invention, said food supplement (Ca) as defined above, is in the form of a solid, and more particularly the form of a tablet, a capsule, a soft capsule, a powder, a dragée, a confectionery gum or a granule. When said food supplement (Ca) as defined above, is in the form of a tablet, it preferably comprises less than 50 mg of said composition (C) such that defined above, for a 500 mg tablet; when it is in the form of a soft capsule, it preferably comprises less than 120 mg of said composition (C) for a 1200 mg soft capsule; when it is in the form of a gelatin capsule, it preferably comprises less than 10 mg of said composition (C) as defined above for a 100 mg gelatin capsule; when it is in the form of a powder, it preferably comprises less than 200 mg of said composition (C) as defined above for a 2000 mg powder. When said food supplement (Ca) is in the form of a powder, it is obtained by introducing its various constituents into a mixer equipped with at least one mechanical stirring system, such as for example flat or propeller-type stirring blades, and the mixer is optionally a percolator mixer, and the mixer is optionally equipped with a lump-chopper system. This mixing operation is generally carried out at room temperature, in particular between 15°C and 30°C. When said food supplement (Ca) is in the form of a confectionery gum, it preferably comprises less than 150 mg of said composition (C) as defined above for a 1.5 g confectionery gum. When the food supplement (Ca) is in the form of a liquid, it preferably comprises less than 100 mg of said composition (C) as defined above for a 1 cm 3 ampoule. The present invention also relates to the cosmetic use in oral administration of the food supplement (Ca) as defined above, to increase the density and length of hair. Finally, the present invention relates to a cosmetic treatment method intended to increase the density and length of hair, characterized in that an effective amount of the food supplement (Ca) as defined above is administered orally. According to a particular aspect of the invention, said food supplement (Ca) as defined above is administered orally at a rate of at least 15 mg, in particular at least 30 mg, of said composition (C) per day for at least 4 weeks, in particular for at least 8 weeks, even more particularly for 12 weeks. The following examples illustrate the invention, without however limiting it. Comparative formulations A commercial wheat gluten extract is used in the form of a powdery composition (C) which comprises for 100% of its mass: 52.5% by mass of sphingolipids, 41.5% by mass of DigalactosylDiacylGlycerol and 6% by mass of phospholipids. Two formulations were prepared, respectively a dietary supplement (Ca) (comprising composition (C)) and a dietary supplement (C'a) (not comprising composition (C)), which comprise the ingredients as shown in Table 1: [Table 1] Amount per capsule Components Dietary supplement (Ca) Dietary supplement (C'a) Composition (C) 15 mg - Maltodextrin 230 mg 245 mg Dicalcium phosphate 100 mg 100 mg Magnesium carbonate 50 mg 50 mg Silica 30 mg 30 mg Magnesium stearate 10 mg 10 mg Total net weight 435 mg 435 mg Total weight 549 mg 549 mg (including capsule weight) 5 Procedure The technical effect of composition (C) was demonstrated in a pilot, randomized, double-blind, parallel-group clinical study. It tested the effect of daily consumption of 30 mg of (C) versus Placebo over a period of 84 days (12 weeks). 10 Caucasian women aged between 18 and 65 years, with telogen effluvium (proportion of hair in the telogen phase > 15%) and complaining of fine and brittle hair, as well as a sebum level greater than or equal to 140 µg/cm², were included in the study. They consumed for 84 days (from D0 to D84) or 2 capsules per day of the supplement food supplement (Ca) or 2 capsules per day of the food supplement (C'a). The measurements were carried out on day 0 (D0) and 56 (D56) and 84 days (D84). A.1- Hair length: Principle of the evaluation method Hair growth was evaluated by measuring the length of 5 hairs after 84 days of supplementation, following their shaving on D0. The improvement in hair growth was also highlighted by the study subjects, thanks to the use of a self-assessment form. Results The results obtained are presented in Table 2. [Table 2] Dietary supplement (C'a) Dietary supplement (Ca) (number of subjects = 32) (number of subjects = 33) Mean ± SEM Mean ± SEM (p vs placebo) D84 3.2 ± 0.1 3.6 ± 0.1 (p=0.0001) SEM: standard error of the measurement Observations - Comments By measuring hair growth at D84 after shaving at D0, a significant increase in hair length was observed between the dietary supplement (Ca) group (containing composition (C)) and the dietary supplement (C'a) group (3.6 ± 0.1 cm vs 3.2 ± 0.1 cm; p<0.001). In addition, after analyzing the responses from the qualitative form, a proportion of 91% of subjects in the dietary supplement group (Ca) reported that their “hair grew faster”, compared to 72% of subjects in the dietary supplement group (C'a). A.2- Hair regrowth: Principle of the evaluation method Hair regrowth was evaluated by performing a phototrichogram, allowing the density and proportion of hair in the anagen and telogen phases to be quantified. As a reminder, the phototrichogram is performed on a fixed area of the scalp with a diameter of 1.8 cm (frontotemporal region or vertex). The hair is shaved there, before coloring the area and taking a first macrophotograph allowing the total hair to be counted; A second macrophotograph taken 48 hours later then allows to differentiate the anagen hairs that have grown from the telogen hairs that have not grown. The total hair density is evaluated by the total number of hairs per cm². The anagen hair density is evaluated by the number of hairs in the anagen phase (having grown during the 48 hours between the 2 macrophotographs) per cm² and proportion (%) compared to the total hair density. Hair regrowth was also analyzed through a clinical evaluation carried out by a dermatologist as well as using a self-assessment form completed by the study subjects. A.2.1- Hair density in the anagen phase: Results The results obtained are presented in Table 3. [Table 3] Food supplement C'a Food supplement Ca (number of subjects = 32) (number of subjects = 33) Mean ± SEM Mean ± SEM % vs D0 % vs D0 (p vs D0) (p vs D0) (p vs placebo) D0 162.6 ± 4.9 - 165.5 ± 3.8 - 173.0 ± 4.2 +4.6% D56 162.8 ± 6.1 -0.13% (p=0.0005) (p=0.043) 170.8 ± 4.9 184.6 ± 4.1 +11.9% D84 +5.6% (p=0.004) (p=0.0001) (p=0.004) SEM: standard error of the measurement Observations - Comments A significant increase in hair density in the anagen phase was observed in the food supplement group (Ca) after 56 days of consumption: from 165.5 ± 3.8 hairs/cm² on D0 to 173.0 ± 4.2 hairs/cm² on D56 (p=0.0005) and 184.6 ± 4.1 hairs/cm² on D84 (p=0.0001), whereas a significant increase was only observed in the food supplement group (C'a) after 84 days of consumption: from 162.6 ± 4.9 hairs/cm² on D0 to 162.8 ± 6.1 hairs/cm² on D56 and 170.8 ± 4.9 hair/cm² at D84 (p=0.004). In addition, there was a significant difference between the food supplement group (Ca) and the food supplement group (C'a) at D56 (+4.6% vs -0.13%; p=0.043) as well as at D84 (+11.9% vs +5.6%; p=0.004). A.2.2- The proportion of hair in the anagen phase: Results The results obtained are presented in Table 4. [Table 4] Dietary supplement (C'a) Dietary supplement (Ca) (number of subjects = 32) (number of subjects = 33) Mean ± SEM Mean ± SEM % vs D0 % vs D0 (p vs D0) (p vs D0) (p vs placebo) D0 81.2 ± 0.5 - 80.9 ± 0.6 - 84.4 ± 0.6 +4.3% D56 82.3 ± 0.8 +1.3% (p=0.0001) (p=0.003) 83.2 ± 0.6 86.0 ± 0.6 +6.5% D84 +2.5% (p=0.002) (p=0.0001) (p=0.0001) SEM: standard error of the measurement Observations - Comments A significant increase in the proportion of hair in the anagen phase was observed in the food supplement group (Ca) after 56 days of consumption: from 80.9 ± 0.6% on D0 to 84.4 ± 0.6% on D56 (p=0.0001) and 86.0 ± 0.6% on D84 (p=0.0001), while a significant increase was observed in the food supplement group (C'a) only after 84 days of consumption: from 81.2 ± 0.5% on D0 to 82.3 ± 0.8% on D56 and 83.2 ± 0.6% on D84 (p=0.002). In addition, there is a significant difference between the food supplement group (Ca) and the food supplement group (C'a) at D56 (+4.3% vs +1.3%; p=0.003) and D84 (+6.5% vs +2.5%; p=0.0001). A.2.3- Total hair density: Results The results obtained are presented in Table 5. [Table 5] Dietary supplement (C'a) Dietary supplement (Ca) (number of subjects = 32) (number of subjects = 33) Mean ± SEM Mean ± SEM % vs D0 % vs D0 (p vs D0) (p vs D0) (p vs placebo) D0 200.5 ± 6.3 - 205.1 ± 5.1 - D56 197.7 ± 7.0 -1.5% 205.3 ± 5.1 +0.2% 214.9 ± 5.0 D84 205.4 ± 6.0 +2.9% +5.1% (p=0.0001) SEM: standard error of the measurement Observations - Comments A significant increase in total hair density was observed in the dietary supplement (Ca) group after 84 days of consumption: 205.1 ± 5.1 hairs/cm² at D0 to 214.9 ± 5.0 hairs/cm² at D84 (p=0.0001), whereas there was no significant change in the food supplement group (C'a): from 200.5 ± 6.3 hairs/cm² at D0 to 205.4 ± 6.0 hairs/cm² at D84. An increase in total hair density was also noted by clinical assessment (performed by a dermatologist) in 61% of subjects in the dietary supplement (Ca) group at D56 (vs. 47% of subjects in the dietary supplement (C'a) group), and in 64% of subjects in the dietary supplement (Ca) group at D84 (vs. 53% of subjects in the dietary supplement (C'a) group). This increase was also evidenced by the study subjects, with 85% of subjects in the dietary supplement (Ca) group reporting that their “scalp was more covered”, compared to 75% of subjects in the dietary supplement (C'a) group. A.3 Conclusions Through the clinical study, composition (C) demonstrated activity in promoting hair growth, through its effect on increasing hair length, and its effect on anagen density and total density. Examples of illustrative formulations [Table 6] Clinical Study Capsule Formula Component Amount per Capsule Composition (C) 15 mg Maltodextrin 230 mg Dicalcium Phosphate 100 mg Magnesium Carbonate 50 mg Silica 30 mg Magnesium Stearate 10 mg [Table 7] Capsule Formula Component Amount per Capsule Composition (C) 30 mg Maltodextrin 220 mg Beet Juice 70 mg Magnesium Stearate 15 mg 5
[Tableau 8] Formule pour capsules molles Composant Quantité par capsule Composition (C) 70 mg Huile de bourrache 400 mg Monostéarate de glycéryle 24,1 mg Vitamine C 14,6 mg Lécithine 14 mg Vitamine B3 2,9 mg Vitamine E 2,7 mg Sélénium 2 mg Cuivre 0,4 mg Vitamine B2 0,2 mg Biotine 0,007 mg Bibliographie 5 (1) Lin et al. Morphogenesis, Growth Cycle and Molecular Regulation. Frontiers in Cell and Developmental Biology 2022, 10:899095. (2) Demande de brevet FR3069160A1: Composition cosmétique ou pharmaceutique favorisant la pousse des cheveux comprenant un lyophilisat de cellules dédifférenciées de criste marine. 10 (3) Nikfar & Jaberidoost. Hair In Encyclopedia of Toxicology (Third Edition), Academic Press, 2014, 813-815. (4) Demande de brevet EP2821052A1: Association de miliacine et de lipides polaires, notamment de sphingolipides et/ou de phospholipides, pour le soin des cheveux et du cuir chevelu.
(5) Yin et al. Telogen Effluvium – a review of the science and current obstacles. Journal of Dermatological Science 2021, 101, 156-163. (6) Hoffmann. TrichoScan: A Novel Tool For The Analysis of Hair Growth In Vivo. Journal of Investigative Dermatology Symposium Proceedings 2003, 8, 109-115.
[Table 8] Softgel Capsule Formula Component Quantity per Capsule Composition (C) 70 mg Borage oil 400 mg Glyceryl monostearate 24.1 mg Vitamin C 14.6 mg Lecithin 14 mg Vitamin B3 2.9 mg Vitamin E 2.7 mg Selenium 2 mg Copper 0.4 mg Vitamin B2 0.2 mg Biotin 0.007 mg Bibliography 5 (1) Lin et al. Morphogenesis, Growth Cycle and Molecular Regulation. Frontiers in Cell and Developmental Biology 2022, 10:899095. (2) Patent application FR3069160A1: Cosmetic or pharmaceutical composition promoting hair growth comprising a lyophilisate of dedifferentiated sea fennel cells. 10 (3) Nikfar & Jaberidoost. Hair In Encyclopedia of Toxicology (Third Edition), Academic Press, 2014, 813-815. (4) Patent application EP2821052A1: Association of miliacin and polar lipids, in particular sphingolipids and/or phospholipids, for the care of hair and scalp. (5) Yin et al. Telogen Effluvium – a review of the science and current obstacles. Journal of Dermatological Science 2021, 101, 156-163. (6) Hoffmann. TrichoScan: A Novel Tool For The Analysis of Hair Growth In Vivo. Journal of Investigative Dermatology Symposium Proceedings 2003, 8, 109-115.
Claims
REVENDICATIONS 1. Composition (C) caractérisée en ce qu’il s’agit d’un extrait de gluten de blé, comprenant pour 100% massique : - de 20% massique à 80% massique d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique d’au moins un phospholipide (a3), et en ce que la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), est égale à 100% massique, pour son utilisation par voie orale, dans une méthode de traitement thérapeutique pour augmenter la densité et la longueur des cheveux. 2. Composition (C) selon la revendication 1, comprenant pour 100% massique : - de 20% massique à 60% massique d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 19% massique à 50% massique de digalactosyldiacylglycérol (a2), et - de 1% massique à 10% massique d’au moins un phospholipide (a3). 3. Composition pharmaceutique comestible (Cp) comprenant pour 100% massique : - de 10% massique à 30% massique d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique, et ladite composition (C) étant un extrait de gluten de blé,
et - de 70% massique à 90% massique d’au moins un additif technologique comestible pharmaceutiquement acceptable, pour son utilisation par voie orale, dans une méthode de traitement thérapeutique pour augmenter la densité et la longueur des cheveux. 4. Composition pharmaceutique comestible (Cp) selon la revendication 3, comprenant en outre, au moins un principe actif choisi parmi les lipides bioactifs, les sels d'oligo-éléments hydrosolubles ou hydro-dispersibles, les vitamines hydrosolubles ou liposolubles, les prébiotiques, les probiotiques, les protéines et/ou les concentrats de protéines laitières, les enzymes végétales ou animales, les acides aminés, les peptides, les sucres, les exhausteurs de goût et les agents aromatisants. 5. Utilisation en administration par voie orale d’une quantité efficace d’une composition (C) comprenant pour 100% massique : de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique et ladite composition (C) étant un extrait de gluten de blé, pour augmenter la densité et la longueur des cheveux. 6. Méthode de traitement cosmétique destinée à augmenter la densité et la longueur des cheveux, caractérisée en ce que l’on administre par voie orale, une quantité efficace d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à
50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique et ladite composition (C) étant un extrait de gluten de blé. 7. Complément alimentaire (Ca) Complément alimentaire (Ca) comprenant pour 100% massique : - plus de 0% massique et moins de 10% massique d’une composition (C) comprenant pour 100% massique : - de 20% massique à 80% massique, plus particulièrement de 20% massique à 60% massique, d’au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, - de 10% massique à 50% massique, plus particulièrement de 19% massique à 50% massique, de digalactosyldiacylglycérol (a2), et - de 1% massique à 30% massique, plus particulièrement de 1% massique à 10% massique, d’au moins un phospholipide (a3), la somme des teneurs massiques dudit au moins un sphingolipide (a1) résultant de l’amidification d’un acide gras sur la sphingosine, dudit digalactosyldiacylglycérol (a2) et dudit au moins un phospholipide (a3), étant égale à 100% massique et ladite composition (C) étant un extrait de gluten de blé, et - plus de 90% massique et moins de 100% massique d’au moins un additif technologique nutritionnellement acceptable. 8. Complément alimentaire (Ca) selon la revendication 7, comprenant en outre, au moins un principe actif choisi parmi les lipides bioactifs, les sels d'oligo-éléments hydrosolubles ou hydro-dispersibles, les vitamines hydrosolubles ou liposolubles, les prébiotiques, les probiotiques, les protéines et/ou les concentrats de protéines laitières, les enzymes végétales ou animales, les acides aminés, les peptides, les sucres, les exhausteurs de goût et les agents aromatisants. 9. Complément alimentaire (Ca) selon l’une quelconque des revendications 7 ou 8, caractérisé
en ce qu’il se présente sous la forme d'un comprimé, d'une gélule, d'une capsule molle, d'une poudre, d'une dragée, d’une gomme de confiserie ou d'un granule. 10. Utilisation cosmétique en administration par voie orale, du complément alimentaire (Ca) selon l’une quelconque des revendications 7 à 9, pour augmenter la densité et la longueur des 5 cheveux. 11. Méthode de traitement cosmétique destinée à augmenter la densité et la longueur des cheveux, caractérisée en ce que l’on administre par voie orale, une quantité efficace du complément alimentaire (Ca) selon l’une quelconque des revendications 7 à 9.
CLAIMS 1. Composition (C) characterized in that it is a wheat gluten extract, comprising for 100% by mass: - from 20% by mass to 80% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass of at least one phospholipid (a3), and in that the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), is equal to 100% by mass, for its oral use, in a method of therapeutic treatment for increasing hair density and length. 2. Composition (C) according to claim 1, comprising for 100% by mass: - from 20% by mass to 60% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 19% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 10% by mass of at least one phospholipid (a3). 3. Edible pharmaceutical composition (Cp) comprising for 100% by mass: - from 10% by mass to 30% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass, and said composition (C) being a wheat gluten extract, and - from 70% by mass to 90% by mass of at least one pharmaceutically acceptable edible technological additive, for its oral use, in a therapeutic treatment method for increasing the density and length of hair. 4. Edible pharmaceutical composition (Cp) according to claim 3, further comprising at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents. 5. Use in oral administration of an effective amount of a composition (C) comprising for 100% by mass: from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, for increasing the density and length of the hair. 6. Cosmetic treatment method intended to increase the density and length of the hair, characterized in that an effective amount of a composition (C) comprising for 100% by mass is administered orally: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract. 7. Food supplement (Ca) Food supplement (Ca) comprising for 100% by mass: - more than 0% by mass and less than 10% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, said digalactosyldiacylglycerol (a2) and said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, and - more than 90% by mass and less than 100% by mass of at least one nutritionally acceptable technological additive. 8. Food supplement (Ca) according to claim 7, further comprising at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and/or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents. 9. Food supplement (Ca) according to any one of claims 7 or 8, characterized in that it is in the form of a tablet, a capsule, a soft capsule, a powder, a dragée, a confectionery gum or a granule. 10. Cosmetic use in oral administration of the food supplement (Ca) according to any one of claims 7 to 9, to increase the density and length of hair. 11. Cosmetic treatment method intended to increase the density and length of hair, characterized in that an effective amount of the food supplement (Ca) according to any one of claims 7 to 9 is administered orally.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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FRFR2304535 | 2023-05-05 |
Publications (1)
Publication Number | Publication Date |
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WO2024231160A1 true WO2024231160A1 (en) | 2024-11-14 |
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