CH715997A1 - Protein drink and dosage unit for the administration of L-leucine-enriched whey protein components as food fortification and its production. - Google Patents

Abstract

The invention relates to a dosage unit for administering whey protein isolate or whey protein hydrolyzate enriched with L-leucine as a food fortification and a method for its production. The administration unit comprises an administration container in which a protein mixture is contained. The protein mixture has a whey protein isolate or whey protein hydrolyzate and an L-leucine component and is in an amount of 10 µg / ml to 40 µg / ml, preferably in an amount of 15 µg / ml to 30 µg / ml, particularly preferably in one Amount from 20 µg / ml to 25 µg / ml.

Description

The invention relates to a protein drink and a dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification and a method for its production according to the independent claims. The invention also relates to a protein drink and a milk product using a dosage unit.

Scientific studies provide increasing evidence, especially in older people, of a significantly improved state of health through increased intake of high-quality protein, such as whey protein with a high L-leucine content. The positive effects on the human body do not exclusively include healthy aging, appetite and weight management and the prevention of disease- or age-related muscle wasting. Muscle wasting can be caused by inactivity, immobilization, bed rest and various diseases. These include, for example, cachexia as a result of cancer, which is one of the most common ultimate causes of death in cancer patients. Muscle wasting can also increase the risk of developing metabolic syndrome, type 2 diabetes and cardiovascular disease.

Furthermore, an increased protein intake in old age leads to improved physical performance, accompanied by increased autonomy, and thus leads to an increased quality of life and a reduction in health costs.

The basis of the positive effects of increased protein, respectively. L-leucine uptake in old age is due to the fact that in old age the muscle cells have a reduced sensitivity to stimulation by essential amino acids (anabolic resistance) compared to boys and this resistance can be compensated for by increased ingestion and in particular a higher amount of leucine.

Experts therefore assume that the daily protein intake in the elderly should be 1.2-2.0 g / kg / d, while the recommended daily protein dose for healthy adults is only 0.8 g / kg / d. Contrary to this, studies show that 10-35% of older adults do not even reach the currently recommended daily amount of 0.8 g / kg / d.

In closing this gap, supplementation with whey protein isolate and / or L-leucine can help, since the maximum stimulation of the myofibrillary protein synthesis rate can be achieved by increasing the L-leucine dose independently of the protein intake. Enrichment with L-leucine can also compensate for insufficient amounts of protein in relation to the increase in muscle protein synthesis. L-leucine must be ingested with food and is mainly found in meat, fish, dairy products, soy and nuts. However, the previously recommended daily requirement of 42 mg / kg / d is not sufficient to exceed the L-leucine threshold for maximum stimulation of muscle protein synthesis per meal. Higher doses are necessary to take full advantage of L-leucine. Quantities of up to 500 mg / kg / d are classified as harmless according to the current state of knowledge. L-leucine for food fortification is e.g. B. from US 5242697 A known.

In the clinical setting (especially in geriatrics) today, whey protein is administered for certain indications. It is administered either by enriching the food prepared for the patient in the hospital or home kitchen or by supplementing it in hospital wards, with the nursing staff preparing drinks either individually or in large quantities by taking a protein powder from large packs and then mixing them. Alternatively, portioned sachets are also used for the preparation, which are transferred to shakers and mixed with a liquid. Both the removal from large packs and the use of sachets are done in addition to the supervised environment by self-sufficient people who still live at home and prepare their meals independently. There is a risk that the large packs can no longer be hermetically sealed, which leads to a reduction in the quality of the powder. Contamination and loss of quality due to improper use must be avoided in the clinical environment. Furthermore, both large packs and sachets are less user-friendly, so that taking the proteins is delayed or even forgotten. For example, it has been proven that tearing open sachets can be a hurdle for the elderly.

It is therefore an object of the present invention to provide a dosage unit and a protein drink for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification and a method for their production which allow simple preparation and consumption, avoid incorrect provision and allow simple production and processing of a protein powder, which enable hygienic administration, ensure an adequate supply of protein and facilitate the ingestion of protein, in particular L-leucine. The invention thus sets itself the task of successfully overcoming the challenges and risks described above which protein supplementation brings with it in the clinical, in particular geriatric, environment.

This object is achieved according to the invention by a dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification according to claim 1, a method for the production thereof according to claim 9 and a protein drink according to claim 16. Advantageous refinements and different embodiments of the invention emerge from the subordinate and ancillary claims and the following description.

Accordingly, a dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification according to the present invention comprises an administration container in which a protein mixture is contained which has a whey protein isolate or whey protein hydrolyzate and an L-leucine component an amount of 10 µg / ml to 40 µg / ml, preferably an amount of 15 µg / ml to 30 µg / ml, particularly preferably an amount of 20 µg / ml to 25 µg / ml. The administration unit preferably comprises a total amount of L-leucine of 30 μg / ml to 70 μg / ml, preferably 45 μg / ml to 55 μg / ml, in the administration container.

[0011] A maximum liquid volume of 150 ml, preferably 100 ml, can advantageously be taken up in the administration container. For this purpose, the container is advantageously dimensioned so that its internal volume corresponds to the specified liquid volume or is only slightly larger. It is therefore not possible to add an excessive amount of liquid to the protein mixture and thereby reduce the protein concentration unintentionally. A liquid volume of 100ml, or even 150ml, can also be consumed by older people without any effort.

Furthermore, the object is achieved according to the invention by a method for producing a dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification, in which a portion of a minimum of 15g and a maximum of 30g, preferably 20g to 25g, one Protein mixture with at least 20% L-leucine is filled into an administration container and an amount of liquid of a maximum of 150 ml, preferably a maximum of 120 ml, particularly preferably a maximum of 100 ml, is added and the protein mixture is dissolved therein.

Furthermore, this object is achieved by a protein drink, or a protein drink product, for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification, which comprises an administration container in which a maximum amount of 150ml, preferably a maximum of 100ml, and a protein mixture is contained with at least 20% L-leucine, the protein mixture having a whey protein isolate or whey protein hydrolyzate and an L-leucine component and in an amount of 10 µg / ml to 40 µg / ml, preferably in an amount of 15 µg / ml to 30 µg / ml, particularly preferably in an amount of 20 µg / ml to 25 µg / ml.

In one embodiment, a total amount of L-leucine in the administration container is 4.5-5.5 g. The administration container preferably has a volume of a maximum of 80 ml to 150 ml, preferably a maximum of 250 ml, and particularly preferably a maximum of 300 ml. A portion of the protein mixture in the administration container is advantageously a minimum of 15 g and a maximum of 30 g, preferably 20 g-25 g.

With the dosage unit according to the invention, it is possible to significantly increase the density of action of L-leucine, since the protein mixture is suitable for presenting the same active ingredient content in smaller amounts of liquid compared to the prior art. The administration of the protein mixture with the dosage unit according to the invention has more than twice the density of action compared to conventional nutritional therapeutic approaches.

The invention can also be used in connection with L-leucine-enriched foods for special medical purposes (FSMP) in powder form for mixing with liquid or as ready-to-drink liquid food. The FSMP can be in the form of isolated protein food (whey protein enriched with L-leucine) as well as partially or fully balanced (proteins, carbohydrates, fats, vitamins and minerals). According to the invention, the FSMP can e.g. B. pre-portioned in a container with 4.5 - 5.5 g leucine per serving. In principle, the portions can also be simply portioned out of a storage container with a measuring spoon and mixed with liquid. The liquid volume per portion is advantageously around 100ml.

A method for producing a powdered protein mixture from whey protein isolate or whey protein hydrolyzate and at least one L-leucine component, preferably a whey protein-L-leucine component, is advantageously used, in which initially an L-leucine content of the whey protein isolate or whey protein hydrolyzate is determined. For example, the content can be determined by analyzing the amino acid profile of the whey protein isolate or whey protein hydrolyzate. Furthermore, an amount of the L-leucine component required for the protein mixture is determined depending on the L-leucine content of the whey protein isolate or whey protein hydrolyzate in such a way that the protein mixture contains at least 20% L-leucine. A fixed amount of the whey protein isolate or whey protein hydrolyzate and the L-leucine component can then be mixed in a conventional manner.

It is emphasized that the powdered protein mixture does not have to contain a source of carbohydrates and / or fat and does not need such a source. The protein mixture can thus be viewed as an isolated protein mixture. Furthermore, the protein mixture can also have whey protein isolate and whey protein hydrolyzate. However, the use of one of these whey protein sources is sufficient, so that hereinafter reference is made to “whey protein isolate or whey protein hydrolyzate”. For some applications it is advantageous if the protein mixture contains a carbohydrate and / or fat component, or components of other proteins, fats, vitamins and / or minerals. With the help of such components it is possible, for example, to produce partially or fully balanced protein foods.

The L-leucine component preferably consists of free or peptide-bound L-leucine or of an L-leucine salt. The L-leucine component should preferably be micronized to reduce the size of the particles, so that preferably around 50% of the particles have a diameter of 140-190 µm, preferably 149-177 µm, around 20% a diameter of 120-160 µm, preferably 125 149 µm, and around 10% have a diameter of <130 µm, preferably <125 µm. In various variants, flavorings, sweeteners and / or colorings can be added to the L-leucine component until there is a homogeneous mixing with regard to the mixing ratio of the particles. In a variant of the production process, the protein mixture is mixed with mono- and / or diglycerides from fatty acids, in particular with 0.05 to 5.0%, preferably with 0.1 to 3.0%, mono- and / or diglycerides.

In one embodiment of the production process, after determining the L-leucine content of the whey protein isolate or whey protein hydrolyzate used (e.g. by analyzing the amino acid profile), taking into account the effective protein content of a whey protein isolate or whey protein hydrolyzate powder, the amount of free or peptide to be added -Leucine or L-leucine salt (based on an initial amount of 18-20 g whey protein isolate or whey protein hydrolyzate) calculated in order to obtain a final total amount of 4.5-5.5 g L-leucine per serving of protein mixture. The L-leucine is then micronized down to a maximum particle size of 190 μm, preferably a maximum of 177 μm, in relation to around 80% of the particles, whereby micronization can be omitted if the L-leucine already has the required particle size. A corresponding particle size is important, as this results in an optimal ratio of the particle sizes of the individual raw materials in the end product. This leads to a better taste and better solubility than with conventional L-leucine-enriched products, as has been determined experimentally.

As a result, the L-leucine can be mixed with a mixture of flavors and sweeteners (if necessary also dyes or coloring foods) of natural or synthetic origin until the mixing ratio of the particles is as homogeneous as possible. In the next step, the flavored and sweetened L-leucine can be mixed with the whey protein isolate or whey protein hydrolyzate, whereby the whey protein isolate or whey protein hydrolyzate can be “instant” and optionally 0.1-3.0% lecithin was added during production. To improve solubility, the protein mixture can also be mixed with mono- and diglycerides from fatty acids.

The production method is advantageously designed in such a way that the protein mixture has no gelling component. If necessary, gelling components are extracted from the protein mixture in the manufacturing process.

For a simple ingestion of L-leucine alone or in combination with whey protein isolate or whey protein hydrolyzate for nutritional fortification, the invention provides the dosage unit described above, a protein drink or product, and a milk product.

In one administration variant, a dosage unit is provided which comprises a powdered mixture of whey protein isolate or whey protein hydrolyzate which is enriched with an L-leucine component, and an administration container. The mixture is pre-portioned and accommodated directly in the administration container and the administration container has a removable, tight closure. The volume of the administration container is sufficiently large so that liquid can be added to the mixture in the container and the mixture can be dissolved in the liquid. In this way, the protein mixture can be taken or supplied directly from the container and all portioning and cleaning steps are omitted. For this purpose, a maximum liquid volume of 150 ml, preferably 100 ml, can advantageously be accommodated in the administration container.

A disposable container, preferably made of recyclable material, is advantageously used as the administration container. The powdery mixture is filled into the container in the desired portioning and the container is then closed. The closure advantageously has a device for a tamper-evident guarantee, as is known from the prior art. After opening the container, a desired amount of liquid is added to the container and the mixture can, for. B. be dissolved by shaking or swiveling.

The delivery unit according to the invention was a kind of ready-to-shake protein drink. It solves both the hygiene and waste problems and guarantees a high level of user-friendliness: The hygienic and pre-portioned filling in the administration container, z. B. a recyclable plastic or glass bottle, guarantees hygiene, environmental compatibility and easy handling during disposal. In addition, the preparation is very easy and thus guarantees a high level of compliance when used at home. Last but not least, the new dosage form means that incorrect dosing, while at the same time guaranteeing the administration of the permissive dose, can almost be ruled out. Accordingly, the unavoidable variance in dosing with measuring spoons is avoided.

In a further variant of administration, a dosage unit is provided which is a ready-to-drink liquid made from whey protein isolate or whey protein hydrolyzate which is enriched with an L-leucine component. The protein mixture is pre-portioned and placed directly in the administration container, as is the required amount of liquid. The protein drink can be taken or added directly from the container and all portioning and cleaning steps are omitted.

The delivery unit according to the invention was a kind of ready-to-drink protein drink. It solves both the hygiene and waste problems and guarantees a high level of user-friendliness: The hygienic and pre-portioned filling in the administration container, eg. B. a recyclable plastic or glass bottle, guarantees hygiene and easy handling during disposal. As a ready-to-drink liquid, there is no need to prepare it, which further increases the user-friendliness in hospitals. Last but not least, the new dosage unit almost eliminates the possibility of incorrect dosing, while at the same time guaranteeing the administration of the permissive dose. Accordingly, the unavoidable variance in dosing with measuring spoons is avoided.

In yet another administration variant, a dosage unit is provided which contains a powdered mixture of whey protein isolate or whey protein hydrolyzate that is enriched with an L-leucine component, as well as balancing components such. B. Carbohydrates, fats, vitamins and minerals. The total mixture is pre-portioned and placed directly in the administration container. The mixture can be dissolved by adding liquid to the mixture in the container. In this way, the protein mixture can be taken or supplied directly from the container and all portioning and cleaning steps are omitted. This dosage unit enables a fully balanced or partially balanced dietary supplement product. Taking additional supplements, such as B. vitamins or minerals can be reduced or even replaced.

In yet another variant of administration, a dosage unit is provided which contains a ready-to-drink liquid made from whey protein isolate or whey protein hydrolyzate that is enriched with an L-leucine component, as well as balancing components such as. B. carbohydrates, fats, vitamins and minerals and an amount of liquid, e.g. B. water, of a maximum of 300ml, preferably 250ml, and particularly preferably of about 100ml. The total mixture and the liquid are pre-portioned and placed directly in the administration container. The protein drink can be taken or added directly from the container and all portioning and cleaning steps are omitted.

A total proportion of L-leucine in the administration container is preferably 4.5-5.5 g. The administration container preferably has a volume of 100 ml. The container can advantageously be slightly larger in order not to have to fill the container to the brim and to provide a free volume for mixing the liquid and total mixture. It can e.g. B. have an internal volume of 110-120ml. A portion of the protein mixture in the administration container is advantageously a minimum of 15 g and a maximum of 30 g, preferably 20 g-25 g.

This dosage unit according to the invention in turn represents a type of ready-to-drink protein drink. As a ready-to-drink liquid, there is no preparation, which further increases the user-friendliness in the hospital. The small drinking volume of 100 ml means a big advantage over existing products. Last but not least, the new dosage unit almost eliminates the possibility of incorrect dosing, while at the same time guaranteeing the administration of the permissive dose. Accordingly, the unavoidable variance in dosing with measuring spoons is avoided.

According to the invention it is also possible to store the powdered mixture of whey protein isolate or whey protein hydrolyzate, which is enriched with an L-leucine component, in a storage container. A portion is taken from the container with a measuring spoon and placed in the administration container, e.g. Shaking beaker, introduced, mixed with liquid and dissolved by shaking or swirling. A total of L-leucine in one serving is e.g. B. 4.5-5.5 g. The powder is mixed with a volume of 100ml to 250ml liquid, preferably about 100ml. A portion of the protein mixture is advantageously a minimum of 15g and a maximum of 30g, preferably 20g-25g, which is predefined by the measuring spoon.

According to a further aspect of the invention, an administration unit, or a food, is provided for administering a powdered protein mixture with L-leucine or a powdered protein mixture of whey protein isolate or whey protein hydrolyzate enriched with an L-leucine component, the protein mixture at least 20 % Contains L-Leucine.

According to a further aspect of the invention, which is not yet claimed in the claims, is a confectionery item, e.g. Biscuits, bars, pralines, chocolate confectionery, etc., provided, which contains a powdery mixture of whey protein isolate or whey protein hydrolyzate and an L-leucine component as described above. A total proportion of L-leucine of at least 4.5g is provided in the confectionery article, preferably the total proportion is between 4.5g and 5.5g.

The confectionery article is used to prevent or treat protein malnutrition. It contains a physiologically effective combination of whey protein isolate or whey protein hydrolyzate and free, salt- or peptide-bound L-leucine or L-leucine salts. A portion of 50 g contains 4.5 to 5.5 g of L-leucine and thus represents a complete and at the same time innovative dosage form for whey protein and L-leucine. Smaller portions contain proportionally less L-leucine. With the confectionery item, patients in hospitals or (elderly) people who are not in hospital treatment can be pre-dosed comfortably and without the risk of over- or under-dosing in be administered in a tasty form.

The powdered protein mixture used for the confectionery article is advantageously produced in accordance with the production method described above.

The procedure for processing the protein mixture in the confectionery article and for producing the confectionery article is as follows. Smooth butter and sugar are whipped lightly with a butter whisk. Cream, butter flavor and lemon paste can be added and mixed in. If desired, flavors can be added and mixed in in the next step. The mass forms a paste. Then take the powdered protein mixture and add salt, vanilla and baking powder as required so that a powder component is ready. This powder component is mixed again and then added to the paste. Paste and powder components are now brought together to form a homogeneous dough-like mass. This is z. B. rolled out on a smooth surface and cut out individual pieces in the desired size and shape. These are placed on a tray and baked at a low temperature, preferably with hot air. After cooling to room temperature, the confectionery article can be trimmed as required or completely or partially with another component, e.g. Chocolate, preferably sugar-free and / or reduced-fat chocolate, are coated. As raw materials for the confectionery z. B. the following substances are used: whey protein isolate or whey protein hydrolyzate, L-leucine free or peptide-bound or in salt form, butter, cane sugar, cream, flour, butter flavoring and other flavors, lemon paste, salt, vanilla and baking powder.

The confectionery article according to the invention represents a simple and tasty way of supplying whey protein and L-leucine to the population. Especially in people with cognitive impairments such as dementia, the eating behavior of patients is changed and compliance with prescribed nutritional therapy measures is low. The confectionery article solves this problem by appealing to the patient in a sensory and emotional way. Due to the way the confectionery product is presented and the sensory experience, it is not perceived as therapy, but as a pleasure.

The following can be summarized for the administration variants according to the present invention: According to the current scientific data, the amount of whey protein necessary for the maximum increase in the myofibrillary muscle protein synthesis rate in geriatrics is around 0.60 g / kg body mass. For a person weighing 70 kg, the whey protein requirement per serving is therefore 42 g. Similarly, the amount of whey protein required for musculoskeletal physiotherapeutic measures in geriatrics or muscle training is ≥ 40 g whey protein per serving. It is important to emphasize that due to the very fast digestion rate of whey protein and the resulting high rate of absorption of the corresponding amino acids and small peptides as well as the whey protein-specific amino acid profile, whey protein is superior to all other types of protein with regard to the increase in myofibrillary muscle protein synthesis and thus sets the clinical standard.

The conventional, available nutritional therapy approaches do not do justice to these facts (amount of protein and quality of the protein source) for three different reasons: Firstly, different manufacturers use protein products which, in addition to whey protein, contain other protein sources that impair the rate of digestion and absorption optimal amino acid profile. As a result, there is no maximally rapid absorption of the amino acids in these products and, in addition, due to the suboptimal amount of essential amino acids, especially L-leucine, too little high blood plasma concentrations are achieved (no exceeding of the L-leucine threshold and therefore no maximum Stimulation of myofibrillary muscle protein synthesis). Secondly, protein quantities of ≥ 40 g per serving result in liquid quantities of ≥ 400 ml depending on the solubility of the protein powder and the viscosity of the drink. Such large drinking quantities are not accepted by geriatric patients and therefore cannot be used in geriatric practice. Thirdly, when conventionally integrated into solid foods, such amounts of whey protein lead to an unpleasant aroma and other sensory disadvantages such as a sandy consistency or increased dry mouth, which makes it impossible to use in geriatrics due to the already reduced saliva production of older people. Fourth, the protein content of conventional pre-portioned protein products is 15-20 g per portion, which makes practical use more difficult due to the doubled dosage (two portions required per serving), reduces adherence to intake and thus increases therapy costs. Last but not least, double dosing also has a negative effect on environmental compatibility (double packaging).

The administration variants according to the invention meet these four hitherto unsolved challenges. First, the protein component of the protein mixture can consist solely of whey protein and L-leucine, if desired. Thus, the administration with a dosage unit according to the invention has an extraordinarily fast passage through the stomach, is digested just as quickly as whey protein and is consequently quickly absorbed. Due to the increased L-leucine content, a significantly higher plasma L-leucine concentration is achieved after ingestion from the dosage unit than with whey protein alone. According to the current scientific data, "suboptimal whey protein quantities" through sufficient L-leucine enrichment reach the L-leucine threshold necessary for the maximum increase in the myofibrillary muscle protein synthesis rate (Churchward-Venne et al. 2014, Devries et al. 2015) and increase as a result the myofibrillar muscle protein synthesis rate is maximal (Churchward-Venne et al. 2014). So z. B. by enriching 6.15 g of whey protein with 4.25 g of L-leucine (total 5 g of L-leucine), as well as maximizing the rate of myofibrillary muscle protein synthesis after a dose of 25 g of whey protein. These amounts are comparable to the content in a dosage unit, a portion of the confectionery article, a protein drink or a milk product according to the invention. Administration with a dosage unit according to the invention or through a confectionery article according to the invention thus achieves a maximum increase in the rate of myofibrillary muscle protein synthesis with a comparatively small amount of whey protein. So-called whey protein equivalents can be calculated on the basis of the L-leucine content of protein-L-leucine mixtures with the same digestive properties as whey protein. These relate to the L-leucine content compared to that of non-fortified whey protein. With 4.5 - 5.5 g of L-leucine per serving, one serving of the protein mixture as it is in the dosage unit, the confectionery item, the protein drink and the milk product, with regard to the L-leucine content, corresponds to 40 - 50 g of whey protein, which is sufficient to maximize the rate of myofibrillar muscle protein synthesis in the majority of elderly people with a body mass of 67-83 kg, such as when bedridden and after musculoskeletal physiotherapy.

Murphy et al. (2016) investigated the effect of chronic L-leucine supplementation of 3 servings of 5 g per day on muscle protein metabolism in older people. It was shown that administration of L-leucine could increase the muscle protein synthesis rate of chronically protein-undersupplied elderly people to the level of those with sufficient protein supply. Thus, by administering L-leucine with the administration variants according to the invention, the muscle protein synthesis rate of chronically protein-undersupplied elderly people can be increased to the level of those who are adequately supplied with protein. Due to the L-leucine content of 5 g per serving of powdered protein mixture in the dosage unit or the confectionery item, they also meet these requirements and are suitable as a measure for L-leucine enrichment in the daily diet when taken three times a day.

Second, the amount of drink in the dosage unit according to the present invention is only about 100 ml, which is easily tolerated in geriatrics. The administration of the protein mixture with the dosage unit according to the invention thus has more than twice the density of action than the conventional nutritional therapy approaches. The amount of food in confectionery items is small due to the high protein and L-leucine concentration. This means that the confectionery product has more than twice the density of active ingredients than conventional nutritional therapy approaches.

Thirdly, solid foods with the protein component according to the invention have an extremely pleasant aroma and do not lead to a sandy consistency and dry mouth. Thus, they are particularly recommended for geriatric use and take into account the various geriatric challenges such as dry mouth and changed motivation to eat, e.g. in cognitively impaired people (dementia patients).

Fourth, as already explained, the physiological needs of an elderly person are covered with only a single administration unit, a confectionery article, a protein drink or a milk product according to the present invention. In addition, the practical application is simplified and the costs are kept as low as possible.

For a high level of compliance with nutritional interventions when used at home by people and patients who take care of themselves independently, good taste, tolerability, amount of drinking and ease of use are decisive. The dosage unit, the confectionery article, the protein drink and the milk product according to the invention meet these requirements. The drinking amount of around 100 ml and the portion size of the confectionery item is optimally matched and tested for geriatrics. In addition, the simplicity of the dosage form guarantees safe and uncomplicated use, which is particularly important for people with cognitive impairments. With regard to the good taste, the inventive administration variants succeed in completely masking the typical, bitter taste of L-leucine thanks to the ingenious production process with coordination of the particle sizes of L-leucine and the aroma components as well as the specified mixing sequence in the production process of the protein mixture. So far, L-leucine supplementation has only taken place via capsules due to the bitterness of L-leucine.

In summary, the administration unit according to the invention and the administration variants according to the invention thus combine a hitherto unattainable clinical effectiveness, a simple, safe and hygienic administration form and excellent taste.

As a further administration variant of the present invention, a milk product is presented which contains a powdery mixture of whey protein isolate or whey protein hydrolyzate with an L-leucine component or exclusively an L-leucine component. The mixture is advantageously produced as set out above. In an advantageous embodiment, the milk product contains 1.0 g to 2.3 g of L-leucine per 100 ml of milk.

The milk product according to the invention is used to prevent or treat protein malnutrition. It preferably consists of animal milk enriched with free or peptide-bound L-leucine or L-leucine salt. Milk can be used by all types of mammals. The milk product is preferably treated by heating, filtration or irradiation to extend its shelf life, it being possible for it to be stored in a cool place or at room temperature. The milk product can e.g. B. in the form of flavored and / or sweetened milk drinks, cheese, yogurt or sauces use.

The milk product according to the invention contains a powdery protein mixture with L-leucine or a powdery protein mixture of whey protein isolate or whey protein hydrolyzate enriched with an L-leucine component.

The milk product can contain a powdered protein mixture which has been prepared as described above. Furthermore, the milk product can be produced by micronizing free or peptide-bound L-leucine or L-leucine salt, so that preferably around 50% of the particles have a diameter of 140-190 μm, preferably 149-177 μm, around 20% a diameter of 120-160 µm, preferably 125-149 µm, and around 10% have a diameter of <130 µm, preferably <125 µm. Micronization can be omitted if the L-leucine already has the required distribution of particle sizes. The L-leucine is now optionally used with other amino acids (e.g. L-glycine) and flavor enhancers such as Enriched monosodium L-glutamate. A corresponding L-leucine particle size distribution is important, as this results in a better taste in the end product than with conventional L-leucine products. The powder is then mixed with milk at around 25-41 ° C, although this may have already been preserved in advance and may be partially skimmed. In addition, the lactose may have been broken down enzymatically. The mixing ratio is 1.00 - 2.30 g L-leucine per 100 ml milk, which equates to a total of 4.5 - 5.5 with a portion of 200 - 300 ml of the milk product. g corresponds to. After mixing, the milk product can be preserved by heating or other suitable methods, if necessary.

Further processing into other milk products is possible. The milk product according to the invention can, for. B. for L-leucine enrichment as a raw material for dairy products such as milk drinks, cheese, yogurt, etc. are used. In addition, the milk product according to the invention can be used for L-leucine enrichment as a milk substitute wherever milk is used for the preparation of meals and foods. Even if not further processed and used as a drink, the milk product according to the invention is suitable for administering sufficiently high amounts of L-leucine. This requires 200-300 ml 3 times a day. This corresponds e.g. B. one glass with each main meal.

Milk is one of the most widely consumed foods worldwide. L-leucine-fortified milk is therefore ideally suited to ensure the basic supply of the population with L-leucine. The population can be supplied directly via the milk product according to the invention as a drink or indirectly via further processing of the milk product, respectively. the use of the dairy product in the preparation of meals.

With the milk product according to the invention, the question of “express medication” no longer necessarily arises. Even people with cognitive impairments or people who subjectively reject food that is perceived as artificial are adequately supplied with protein and / or L-leucine. An important supply gap can thus be closed with the milk product according to the invention. Whether the dairy product through hospital or home kitchens, resp. used in gastronomy, through integration in dairy products or in home use is irrelevant.

The present invention further provides a production method for producing an enrichment component, or an enrichment agent, for enriching carbohydrate-containing and / or fat-containing foods with protein, which has not yet been the subject of the claims. In the manufacturing process for the enrichment component, a total of 4.5-5.5 g of L-leucine per serving is provided per serving. A carrier component is also provided in a ratio between 1: 9 and 9: 1 relative to the total amount of L-leucine. The carrier component is heated to at least the melting point. Then the total amount of L-leucine is added to the carrier component and mixed into a protein mixture while maintaining the temperature. The protein mixture is cooled and represents the enrichment component or the enrichment agent.

In the production process, L-leucine is preferably used in the form of free or peptide-bound L-leucine or as L-leucine salt and / or as the L-leucine component of a whey protein isolate or whey protein hydrolyzate. Furthermore, when using whey protein isolate or whey protein hydrolyzate to provide L-leucine, the L-leucine content of the whey protein isolate or whey protein hydrolyzate is preferably determined by analyzing the amino acid profile of the whey protein isolate or whey protein hydrolyzate. Artificial or natural aromas, spices and / or sweeteners can be added. A powdered mixture of whey protein isolate and / or whey protein hydrolyzate and at least one L-leucine component, which was produced as described above, is preferably used in the production process for the enrichment component.

The enrichment agent according to the invention is used for protein and / or L-leucine enrichment of foods and meals for the prevention and treatment of protein malnutrition by inpatients and outpatients and in particular by people over the age of about 50 years who are not are under medical treatment (healthy and asymptomatic). The enrichment enables cooks, private individuals and food manufacturers, food and meals either with a physiologically effective combination of whey protein isolate or whey protein hydrolyzate and free, resp. enrich peptide-bound L-leucine or L-leucine salt or directly free, respectively. Add peptide-linked L-leucine or L-leucine salt and thus integrate the whey protein L-leucine supplementation into your daily diet in a natural and tasty way.

It is emphasized that the enrichment agent produced by the process according to the invention does not gel since it consists of hydrolyzate or modified isolate. In contrast, conventional L-leucine mixtures made from whey protein gel. However, this is not desirable for all L-leucine enrichment applications. In its basic variant, the enrichment agent according to the invention does not contain any gelling component and therefore extends the area of application for foods enriched with L-leucine.

In one version of the production method for the enrichment agent, in particular for foods containing carbohydrates, a carbohydrate component is used as the carrier component. When cooling down, the protein mixture is hardened. This hardened mixture is then comminuted into a lumpy enrichment agent with pieces with a diameter between 0.5mm and 5mm. The crushed enrichment agent can easily be used for foods containing carbohydrates.

In this version of the manufacturing process, the carbohydrate component is preferably in the form of mono- and / or disaccharides. For certain foods containing carbohydrates, such as B. sweet dishes, the carbohydrate component is preferably heated to caramelize. Furthermore, the hardened mixture of the enrichment agent is broken up into pieces in the form of splinters, crumbles, crumbs or flakes and can thus meet the different requirements of carbohydrate-containing foods.

An enrichment preparation method, which is particularly suitable for carbohydrate-containing foods, can e.g. B. be done as follows. Free or peptide-linked L-leucine or L-leucine salt is weighed. Optionally, the L-leucine can be flavored or sweetened artificially or naturally. Thereafter, mono- or disaccharides are provided, and these can be present in pure form or mixed in any desired ratio. All sugars and sugar substitutes that are permitted in food can be used as mono- and disaccharides. If several mono- and / or disaccharides are used, these are then mixed in the desired ratio. The mono- and / or disaccharides are then weighed out so that they are present as a carbohydrate component in a ratio of 1: 9 to 9: 1 to L-leucine. The carbohydrate component is now slowly heated to the temperature that corresponds to the melting point. Optionally, further heating up to caramelization takes place. Then the L-leucine is added under strict control of the temperature and the entire mass is mixed together immediately. To cool down, respectively. After hardening, the mass can be filled into a separate, possibly shaping vessel. After the mixture of L-leucine and carbohydrate components has reached room temperature, it can be crushed into pieces with a diameter of 0.5 - 5 mm using a crusher, if necessary. These are then advantageously sieved.

In a variant of this enrichment production process, a whey protein isolate or whey protein hydrolyzate is also used in addition to L-leucine. After determining the L-leucine content of the whey protein isolate used (e.g. by analyzing the amino acid profile), taking into account the effective protein content of the whey protein isolate or whey protein hydrolyzate, the amount of free or peptide-bound L-leucine or L-leucine salt to be added is calculated to to obtain an L-leucine content of 20-30% in the protein component of the enrichment agent. Then whey protein isolate or whey protein hydrolyzate and L-leucine are mixed until a homogeneous mixture is obtained as a protein component for the production of the enrichment agent. Optionally, the mixture can be flavored and / or sweetened artificially or naturally.

As previously described, mono- and / or disaccharides are supplemented in such a way that they are present as the carbohydrate component in relation to the protein component in a ratio of 1: 9 to 9: 1. The carbohydrate component is in turn slowly heated to the temperature which corresponds to the melting point of the component and, optionally, caramelization can take place. After mixing and cooling, the hardened mixture is crushed into pieces as before and these are then sieved.

The areas of application of the enrichment agent for carbohydrate-containing foods are diverse. It can be incorporated into any carbohydrate-containing food, whereby it should be taken into account that preferably per portion of the food, respectively. the food contains 4.5-5.5 g L-leucine. The following areas of application are conceivable, for example and not limited to: enrichment of mueslis, bars and baked goods, toppings on confectionery goods or desserts, component of chocolate or confectionery, component of spreads and / or dairy products or pastries.

For example, muesli have so far primarily been foods for energy supply through carbohydrates. By adding the enrichment agent, they can also become sources of protein. Muesli can provide one meal portion of protein (around 20 g) per serving, for B. can be enriched by the enrichment agent made with whey protein isolate, whereby this amount unfolds the physiological effect of 40-50 g whey protein thanks to the high L-leucine content. By enriching with L-leucine without whey protein isolate, an advantageous amount of 5 g of L-leucine can easily be administered per serving of muesli.

In another version of the manufacturing process for the enrichment agent, which is intended in particular for fatty foods, a fat component made from vegetable and / or animal fats is used as the carrier component. The fat component can advantageously be composed of several fats, the several fats being mixed to form a fat mixture. The fat mixture is heated above the melting point of the fat mixture and the heated fat mixture is mixed for at least 60 seconds at at least 120 revolutions per minute. After the fat mixture has cooled down, it is provided as a fat component of the enrichment agent.

As previously mentioned, the enrichment agent made according to the invention does not contain any gelling components. Advantageously, however, a thickening agent can optionally be added to the mixture. The mixture is then cooled in such a way that it cools to a solid or pasty or creamy enrichment agent.

An enrichment preparation method, which is particularly suitable for fatty foods, can, for. B. be carried out as follows: Free or peptide-bound L-leucine or L-leucine salt is weighed. Vegetable or animal fats are then provided, and these can be present in pure form or mixed in any desired ratio. If several fats are used, these are then mixed in the desired ratio and heated to slightly above the melting point of the fat mixture and then mixed for preferably 60 s at preferably 120 revolutions / min. After the fat mixture has cooled to room temperature, the fats are weighed out so that they are present as a fat component in a ratio of 1: 9 to 9: 1 to the L-leucine. If a firm consistency is required in the end product in which the enrichment agent is used, a thickener (e.g. guar gum) can be added. As an alternative or in addition, spices and / or aromas can also be added. The fat component is now slowly reheated to the temperature that corresponds to the melting point of the component. Then the L-leucine is added under strict control of the temperature, the entire mass is immediately mixed with one another and allowed to cool, respectively. Cure filled in a separate container.

Here too, in a variant of this enrichment preparation process, a whey protein isolate or whey protein hydrolyzate can also be used in addition to L-leucine, the procedure being as previously described.

The enrichment agent produced in this way can be incorporated into any fatty food, it should be taken into account that per serving of the food, respectively. the food, preferably 4.5-5.5 g L-leucine are included. The following areas of application are conceivable, for example and not limited to: Enrichment of sausage products, sausage meat, sauces for cold or warm meals, spreads, salty baked goods, meat dishes such as e.g. Pates and meatloaf and pastries or pasta such as spaetzle, cheese, cream cheese, butter. Sausage products are nutritionally enhanced by the enrichment in such a way that they have a positive effect on muscle protein synthesis. This will make you a higher quality food.

With an enrichment agent according to one of the manufacturing processes presented, whey protein and / or L-leucine can be integrated into conventional foods, whereby these are enriched with L-leucine and / or whey protein so that they can be used for the prevention and therapy of protein malnutrition can be. So far, L-leucine has only been administered via capsules (if at all). Whey protein was administered in the form of a drink or enrichment was carried out by incorporating protein powders into dishes (e.g. soups or desserts). The production process according to the invention gives the food industry completely new possibilities, such as the use of crisps, flakes, caramel shavings, pastes and lumps of fat for the administration of L-leucine.

This creates completely new possibilities in prevention and therapy and the proteins can be integrated into basic nutrition in a simplified manner. Food enriched with the enrichment agents improve the protein and L-leucine supply of the aging population in a simple and efficient way, respectively. effective way: patients and healthy elderly people can be looked after without having to forego food they are used to. Since the processes completely neutralize the bitter taste of L-leucine, they enable a pleasant taste experience.

By integrating the enrichment in conventional food, the highest possible adherence to intake is achieved. Patients and users are no longer exclusively dependent on special foods and food additives that contain proteins, but are supplied with sufficient proteins including sufficient amounts of L-leucine through their daily diet. Even people with cognitive impairments or people who subjectively reject food that is perceived as artificial are adequately supplied with protein and / or L-leucine. This closes an important supply gap.

Further aspects of the present invention not previously claimed in the patent claims relate to: <tb> <SEP> A process for the production of a powdery protein mixture from whey protein isolate or whey protein hydrolyzate and at least one L-leucine component for nutritional fortification, wherein <tb><SEP> <SEP> - an L-leucine content of the whey protein isolate or whey protein hydrolyzate is determined and <tb><SEP> <SEP> - an amount of the L-leucine component required for the mixture depending on the L-leucine content of the whey protein isolate or whey protein hydrolyzate is determined in such a way that the protein mixture contains at least 20% L-leucine.

The manufacturing method defined above, characterized in that the L-leucine component consists of free or peptide-bound L-leucine or of an L-leucine salt.

The manufacturing process defined above, characterized in that the L-leucine component is micronized in such a way that preferably around 50% of the particles have a diameter of 140-190 μm, preferably 149-177 μm, around 20% a diameter of 120 -160 µm, preferably 125-149 µm, and around 10% have a diameter of <130 µm, preferably <125 µm.

The manufacturing process defined above, characterized in that flavoring, sweetening and / or coloring agents are added to the L-leucine component until the particle size is homogeneous.

The production process defined above, characterized in that the protein mixture is mixed with mono- and / or diglycerides from fatty acids, in particular with 0.05 to 5.0%, preferably with 0.1 to 3.0%, mono- and / or diglycerides.

A dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification comprising: <tb> <SEP> - a powdered protein mixture of whey protein isolate or whey protein hydrolyzate and an L-leucine component and <tb> <SEP> - an administration container, the protein mixture being pre-portioned and accommodated directly in the administration container and the administration container having a removable, tight closure.

The previously defined dosage unit, characterized in that the protein mixture is produced according to the production process described above.

The previously defined administration unit, characterized in that a portion of the protein mixture in the administration container is a minimum of 15g and a maximum of 30g, preferably 20g-25g.

A confectionery article which contains a powdery protein mixture with L-leucine or a powdery protein mixture of whey protein isolate or whey protein hydrolyzate enriched with an L-leucine component.

The previously defined confectionery article, characterized in that the protein mixture is produced according to the production method described above.

The previously defined confectionery article, characterized in that a total proportion of L-leucine in the confectionery article is at least 4.5-5.5 g.

A milk product which contains a powdery protein mixture with L-leucine or a powdery protein mixture of whey protein isolate or whey protein hydrolyzate enriched with an L-leucine component.

The milk product defined above, characterized in that the protein mixture is produced according to the production method described above.

The milk product defined above, characterized in that the product contains 1.0 g to 2.3 g of L-leucine per 100 ml of milk.

A method for producing an enrichment agent for enriching carbohydrate-containing and / or fat-containing foods with protein, comprising the following steps: <tb> <SEP> - providing a total of 4.5 - 5.5 g L-leucine per serving, <tb> <SEP> - providing a carrier component in a ratio between 1: 9 and 9: 1 relative to the total amount of L-leucine, <tb> <SEP> - heating the carrier component at least up to the melting point of the carrier component, <tb> <SEP> - adding and mixing the total amount of L-leucine with the carrier component to form a mixture while maintaining the temperature, <tb> <SEP> - cooling the mixture, which can be used as an enrichment agent.

The manufacturing process described above, characterized in that L-leucine is used in the form of free or peptide-bound L-leucine or as L-leucine salt and / or as the L-leucine component of a whey protein isolate or whey protein hydrolyzate.

The manufacturing process described above, characterized in that when using whey protein isolate or whey protein hydrolyzate to provide L-leucine, the L-leucine content of the whey protein isolate or whey protein hydrolyzate is determined by analyzing the amino acid profile of the whey protein isolate or whey protein hydrolyzate.

The manufacturing method described above, characterized in that artificial or natural aromas, spices and / or sweeteners are added.

The production method described above, characterized in that a powdered protein mixture of whey protein isolate or whey protein hydrolyzate and at least one L-leucine component is used, which is produced according to one of claims 1 to 5.

The manufacturing method described above, characterized in that a thickener is added to the enrichment agent.

A first variant of the above-described manufacturing process for an enrichment agent for enriching foods containing carbohydrates, <tb> <SEP> - in which a carbohydrate component is used as the carrier component, <tb> <SEP> - the mixture hardens and <tb> <SEP> - the hardened mixture is then crushed to a lumpy enrichment agent with pieces with a diameter between 0.5 mm and 5 mm.

The first variant of the manufacturing process described above, characterized in that the carbohydrate component is in the form of mono- and / or disaccharides.

The first variant of the manufacturing process described above, characterized in that the carbohydrate component is heated until it is caramelized.

The first variant of the manufacturing process described above, characterized in that when using whey protein isolate or whey protein hydrolyzate to provide L-leucine, the hardened mixture is crushed into pieces with a diameter between 1.0 mm and 5 mm.

The first variant of the manufacturing process described above, characterized in that the hardened mixture of the enrichment agent is comminuted into pieces in the form of splinters, crumbles, crumbs or flakes.

A second variant of the above-described manufacturing process for an enrichment agent for the enrichment of fat-containing foods, in which a fat component made from vegetable and / or animal fats is used as the carrier component.

The second variant of the manufacturing process described above, characterized in that the fat component is composed of several fats, wherein <tb> <SEP> - the several fats are mixed into a fat mixture, <tb> <SEP> - the fat mixture is heated above the melting point of the fat mixture, <tb> <SEP> - the heated fat mixture is mixed for at least 60 seconds at at least 120 revolutions per minute and <tb> <SEP> - after the fat mixture has cooled down, it is provided as a fat component of the enrichment agent.

The second variant of the manufacturing process described above, characterized in that the mixture cools down on cooling to a solid or pasty or creamy enrichment agent.

The applicant reserves the right to refer to these previously not claimed aspects of the invention in order to specify existing patent claims or to direct a separate patent application to these aspects.

Claims (19)

1. Dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a nutritional enrichment, which comprises an administration container in which a protein mixture is contained, the protein mixture having a whey protein isolate or whey protein hydrolyzate and an L-leucine component and in an amount of 10 µg / ml to 40 µg / ml, preferably in an amount of 15 µg / ml to 30 µg / ml, particularly preferably in an amount of 20 µg / ml to 25 µg / ml. 2. Administration unit according to claim 1, characterized in that a maximum liquid volume of 150ml, preferably 100ml, can be received in the administration container. 3. Dosage unit according to claim 1 or 2, characterized in that the protein mixture is in powder form and pre-portioned is accommodated in the administration container. 4. Dosage unit according to one of the preceding claims, characterized in that a total amount of L-leucine in the administration container is 30 µg / ml to 70 µg / ml, preferably 45 µg / ml to 55 µg / ml. 5. Dosage unit according to one of the preceding claims, characterized in that the protein mixture is partially or fully balanced. 6. Dosage unit according to the preceding claim, characterized in that the protein mixture has at least one balancing component in the form of carbohydrates, fats, vitamins and / or minerals. 7. Dosage unit according to one of the preceding claims, characterized in that the protein mixture has no gelling component. 8. Dosage unit according to one of the preceding claims, characterized in that the total amount of L-leucine in the administration container is 4.5-5.5 g. 9. A process for the production of a dosage unit for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification, wherein - a protein mixture of whey protein isolate or whey protein hydrolyzate and at least one L-leucine component which contains at least 20% L-leucine is used, - a portion of the protein mixture of a minimum of 15g and a maximum of 30g, preferably 20g to 25g, is filled into an administration container, and - an amount of liquid of a maximum of 150 ml, preferably a maximum of 120 ml, particularly preferably a maximum of 100 ml is added and the protein mixture is dissolved therein. 10. Production method according to claim 9, characterized in that the protein mixture is produced by an L-leucine content of the whey protein isolate or whey protein hydrolyzate is determined and an amount of the L-leucine component required for the mixture depending on the L-leucine content of the Whey protein isolate or whey protein hydrolyzate is determined such that the protein mixture contains at least 20% L-leucine. 11. Manufacturing method according to claim 9 or 10, characterized in that the L-leucine component consists of free or peptide-bound L-leucine or of an L-leucine salt. 12. Production method according to one of claims 9 to 11, characterized in that the L-leucine component is micronized in such a way that preferably around 50% of the particles have a diameter of 140-190 µm, preferably 149-177 µm, around 20% Diameters of 120-160 µm, preferably 125-149 µm, and around 10% a diameter of <130 µm, preferably <125 µm. 13. Production method according to one of claims 9 to 12, characterized in that the protein mixture is mixed with mono- and / or diglycerides from fatty acids, in particular with 0.05 to 5.0%, preferably with 0.1 to 3.0%, mono- and / or diglycerides. 14. Production method according to one of claims 9 to 13, characterized in that the protein mixture is mixed with at least one balancing component in the form of carbohydrates, fats, vitamins and / or minerals. 15. Production method according to one of claims 9 to 14, characterized in that the protein mixture has no gelling component or that gelling components are extracted from the protein mixture. 16. Protein drink for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a nutritional fortification, in which a liquid amount of a maximum of 150ml, preferably a maximum of 100ml, and a protein mixture is contained, the protein mixture being a whey protein isolate or whey protein hydrolyzate and an L-leucine component and is present in an amount of 10 µg / ml to 40 µg / ml, preferably in an amount of 15 µg / ml to 30 µg / ml, particularly preferably in an amount of 20 µg / ml to 25 µg / ml. 17. Protein drink according to claim 16, characterized in that it is designed as a dosage unit according to one of claims 1 to 8. 18. Milk product in the form of a dosage unit according to one of claims 1 to 8 for the administration of L-leucine-enriched whey protein isolate or whey protein hydrolyzate as a food fortification. 19. Milk product according to claim 18, characterized in that it contains a powdery protein mixture with L-leucine or a powdery protein mixture of whey protein isolate enriched with an L-leucine component or whey protein hydrolyzate containing at least 20% L-leucine.