CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and any benefit of U.S. Provisional Application No. 62/054,439, filed September 24, 2014, the content of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure is directed to a protein system comprising dairy and non-dairy protein sources for use in nutritional compositions.

BACKGROUND

[0003] Nutritional compositions may be used to provide nutritional and performance supplementation. Generally, the compositions provide a balanced macronutrient (proteins, carbohydrates, and fats) profile along with a micronutrient profile to meet the nutritional needs of a specific use.

[0004] Often, the protein source in these nutritional compositions is a dairy protein given their generally acceptable flavor and stability characteristics and their favorable amino acid profiles. As dairy proteins tend to be costly, it would be desirable to use a combination of dairy and non- dairy proteins in the compositions to reduce costs. However, such protein combinations present problems because certain types of non-dairy proteins, or the use of too high a concentration of non-dairy proteins, negatively impacts the flavor and stability of the nutritional compositions, and may result in an incomplete amino acid profile. SUMMARY

[0005] It has been found that the embodiments of the protein systems, according to the present disclosure, have improved palatability, mouthfeel, and/or stability, while still providing a suitable amino acid profile.

[0006] In one embodiment, a protein system for use in nutritional compositions is provided. The protein system consists of at least one dairy protein in combination with at least one non-dairy protein, wherein the dairy protein constitutes no more than 60% of the protein system, and wherein the non-dairy protein constitutes at least 40% of the protein system.

DETAILED DESCRIPTION

[0007] Embodiments of the present disclosure provide protein systems for use in compositions, such as compositions for nutritional and/or performance benefits. The nutritional compositions may be pediatric nutritional compositions, adult nutritional compositions, or performance- enhancing nutritional compositions. The protein system may be used in any form of nutritional composition including, for example, liquid, spray-dried, dry-blended, and extruded powdered nutritional compositions. The nutritional compositions may be in the form of a nutritional shake, a nutritional powder, a nutritional liquid, or a nutritional bar.

[0008] The term "nutritional composition" as used herein, unless otherwise specified, refers to nutritional products in various forms including, but not limited to, liquids, solids, powders, semisolids, semi-liquids, nutritional supplements, and any other nutritional food product known in the art. A nutritional composition in powder form may often be reconstituted to form a nutritional composition in liquid form. The nutritional compositions disclosed herein are generally suitable for oral consumption by a human and may be manufactured by any known or otherwise suitable method for making nutritional compositions.

[0009] The terms "nutritional powder" and "reconstitutable powder" as used herein, unless otherwise specified, refer to nutritional compositions in flowable or scoopable form that can be reconstituted with water or another aqueous liquid prior to consumption, and include both spray dried and drymixed/dryblended powders and combinations thereof. [0010] The term "nutritional liquid" as used herein, unless otherwise specified, refers to nutritional compositions in ready-to-drink liquid form, concentrated liquid form, and nutritional liquids made by reconstituting nutritional powders described herein prior to use. The nutritional liquid may also be formulated as a suspension, an emulsion, a solution, and so forth.

[0011] The terms "administer," "administering," "administered," and "administration" as used herein, unless otherwise specified, should be understood to include providing a composition to an individual, the act of consuming a composition, and combinations thereof.

[0012] The compositions according to certain embodiments disclosed herein include those suitable for oral administration. Oral administration, as defined herein, includes any form of administration in which the composition passes through the esophagus of the individual. For example, oral administration includes nasogastric and naso-jejunal intubation, in which a tube is run through the nose to the stomach of the individual to administer food or drugs.

[0013] Non-limiting examples of suitable solid nutritional compositions include snack and meal replacement products, including those formulated as bars, sticks, cookies, breads, cakes, or other baked goods, frozen liquids, candy, breakfast cereals, reconstitutable powders, granulated solids, or other particulates, snack chips or bites, and frozen or retorted entrees.

[0014] Non- limiting examples of liquid product forms suitable for use herein include snack and meal replacement products, hot or cold beverages, carbonated or non-carbonated beverages, juices or other acidified beverages, milk or soy-based beverages, shakes, coffees, teas, and enteral feeding compositions. These liquid compositions are most typically formulated as suspensions or emulsions, but can also be formulated in any other suitable forms such as clear liquids, substantially clear liquids, solutions, and liquid gels.

[0015] Other non- limiting examples of suitable oral product forms include semi-solid or semi- liquid compositions (e.g., puddings, gels), as well as more conventional product forms such as capsules, tablets, cap lets, and pills.

[0016] Certain embodiments of the nutritional compositions disclosed herein comprise a :— oteins, carbohydrates, and fats. Any suitable carbohydrate, fat source, or both, may be included as part of the nutritional compositions. In certain embodiments, the carbohydrate component comprises maltodextrin (and specifically low DE Maltodextrin such as DE10 maltodextrin), corn maltodextrin, sucromalt, maltitol, maltitol powder, glycerine, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates (e.g., tapioca dextrin), isomaltulose, sucrose, extra fine white sugar, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), high intensity sweeteners (e.g., sucralose, acesulfame potassium, stevia, monk fruit), fructooligosaccharides, soy fiber, corn fiber, guar gum, konjac flour, polydextrose, Fibersol, and combinations thereof.

[0017] In certain embodiments, the carbohydrate component of the nutritional compositions comprises both starches and sugars. If so, the amount of sugar in nutritional compositions especially formulated for promoting muscle growth in adults may desirably represent about 1% to about 25%, about 3% to about 10%>, or even about 4% to about 8%, by weight, of the total amount of carbohydrates in the composition. Similarly, the amount of sugar in nutritional compositions especially formulated to provide balanced nutritional supplements for normal adults, as well as for diabetic adults, may desirably represent about 10%> to about 60%>, about 15%o to about 30%), or even about 20%> to about 25%, by weight, of the total amount of carbohydrates in the composition. In addition, the amount of sugar in nutritional compositions especially formulated for children (e.g., ages 1 to 16), both as supplements as well as a sole source of nutrition, may desirably represent about 30% to about 70%, about 40% to about 65%, or even about 50% to about 60%, by weight, of the total amount of carbohydrates in the composition.

[0018] In certain embodiments, the fat component of the nutritional compositions may comprise coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.

[0019] In certain embodiments, the protein comprises a protein system including two or more sources of protein. Traditionally, milk proteins have been the proteins of choice for making a wide varietv nf different nutritional compositions. For various reasons, including a reduction in costs, a combination of dairy and non-dairy proteins may be used in the protein system to reduce the amount of dairy protein that would otherwise be required. However, non-dairy proteins were generally found to have negative impacts on flavor, odor, viscosity (in the case of liquids), texture, short term stability, long term shelf stability, and nutritional value.

[0020] It has been found that the embodiments of the protein systems, according to the present disclosure, provide a suitable amino acid profile while having improved palatability, mouthfeel, and/or stability. In accordance with embodiments of the protein systems disclosed herein, it has been found that negative impacts on the flavor and stability of the nutritional compositions, can be avoided or otherwise mitigated by strictly controlling the concentrations of dairy and non- dairy proteins found in the protein system. In particular, it has been found that the amount of non-dairy protein that can be included in a protein system intended for oral administration can be increased beyond values previously deemed acceptable, without introducing undesirable flavor notes and mouthfeel, if the relative concentrations of dairy to non-dairy protein combinations are tightly maintained. Wide variations in concentration within the protein system may have noticeable consequences surrounding mouthfeel, stability, and performance of the nutritional composition.

[0021] The embodiments of the protein systems disclosed herein incorporate a combination of dairy and non-dairy protein sources. In certain embodiments, the dairy protein may be selected from the group consisting of milk protein concentrate, milk protein isolate, whey protein concentrate, skim milk, skim milk powder, non-fat dry milk, whole milk, whole milk powder, whey protein isolate, whey protein, sodium caseinate, calcium caseinate, and combinations thereof. The non-dairy protein may be selected from the group consisting of soy protein, pea protein, rice protein, potato protein, mycoprotein, macroalgae protein, microalgae protein, canola protein, wheat protein, collagen protein, peanut protein, corn protein, oat protein, sunflower protein, and combinations thereof. Further, it has been found that use of particular combinations of proteins overcomes some of the afore -mentioned drawbacks. In certain embodiments of the protein system, the dairy protein is milk protein concentrate and the non-dairy protein is either soy protein, canola protein, or wheat protein. In certain other embodiments, the non-dairy protein is a mixture of pea protein and wheat protein, mycoprotein and wheat protein, mycoprotein and rice protein, or mycoprotein and corn protein.

[0022] Embodiments of the protein systems consist of at least one dairy protein in combination with at least one non-dairy protein. In certain embodiments, the dairy protein constitutes no more than 60% of the protein system and the non-dairy protein constitutes at least 40% of the protein system. In other embodiments, the dairy protein constitutes no more than 55% of the protein system and the non-dairy protein constitutes at least 45% of the protein system. In other embodiments, the dairy protein constitutes no more than 45% of the protein system and the non- dairy protein constitutes at least 55% of the protein system. In further embodiments, the dairy protein constitutes no more than 40% of the protein system and the non-dairy protein constitutes at least 60% of the protein system.

[0023] In certain embodiments, the dairy protein constitutes no more than 50% of the protein system and the non-dairy protein constitutes at least 50% of the protein system. It has been found that increasing the amount of non-dairy protein in a nutritional composition well above 50% (e.g. greater than 60%) decreases the palatability and the physical stability of the nutritional composition. It has also been found that decreasing the amount of non-dairy protein far below 50%) (e.g. less than 40%>) greatly increases costs. To alleviate these negative effects, certain embodiments of the present disclosure maintain the concentrations of both dairy and non-dairy proteins at approximately 50%, which also allows for a complete or otherwise suitable amino acid profile as discussed below.

[0024] The protein systems disclosed herein comprise an amino acid profile which meets or exceeds the recommendations found in the FAO/WHO/UNU 2007 Joint Report and in the FNB/IOM 2005 Panel Report which each set forth the minimum amounts of essential amino acids that should be present in foods intended for consumption by normal healthy humans. Essential amino acids are defined as those that cannot be synthesized from simpler molecules in normal healthy humans to meet the needs of the body, and therefore must be provided in the diet. As is understood in the nutritional arts, the Food and Agriculture Organization of the United Nations (FAO) has established certain requirements for the quality of the proteins in foods intended for human consumption. Additionally, the Food and Nutrition Board (FNB) of The Institute of Medicine (IOM), which acts under the National Academy of Sciences, has also established certain requirements for the quality of the proteins in foods intended for human consumption.

[0025] In certain embodiments of the protein system, the profile of essential amino acids comprises at least 15 mg/g protein of histidine, at least 30 mg/g protein of isoleucine, at least 59 mg/g protein of leucine, at least 45 mg/g protein of lysine, at least 16 mg/g protein of methionine, at least 6 mg/g protein of cysteine, at least 38 mg/g protein of phenylalanine plus tyrosine, at least 23 mg/g protein of threonine, at least 6 mg/g protein of tryptophan, and at least 39 mg/g protein of valine. This amino acid profile comports with the recommendations as set forth in the FAO/WHO/UNU 2007 Joint Report.

[0026] In certain embodiments of the protein system, the profile of essential amino acids comprises at least 14 mg/kg/day of histidine, at least 19 mg/kg/day of isoleucine, at least 42 mg/kg/day of leucine, at least 38 mg/kg/day of lysine, at least 19 mg/kg/day of methionine plus cysteine, at least 33 mg/kg/day of phenylalanine plus tyrosine, at least 20 mg/kg/day of threonine, at least 5 mg/kg/day of tryptophan, and at least 4 mg/kg/day of valine. This amino acid profile comports with the recommendations as set forth in the FNB/IOM 2005 Panel Report. Units reported in mg per kg of body weight per day.

[0027] Additionally, as set forth in the FNB/IOM 2005 Panel Report, the recommended amino acid scoring pattern for proteins in adults is: 25 mg/g of protein of isoleucine, 55 mg/g of protein of leucine, 51 mg/g of protein of lysine, 25 mg/g of protein of methionine plus cysteine, 47 mg/g of protein of phenylalanine plus tyrosine, 27 mg/g of protein of threonine, 7 mg/g of protein of tryptophan, 32 mg/g of protein of valine, and 18 mg/g of protein of histidine. In certain embodiments, the protein system satisfies the Protein Digestibility Corrected Amino Acid Score (PDCAAS) pattern.

[0028] In certain embodiments, the nutritional compositions described herein contain protein, carbohydrate, and fat components in proportions which are suitable for satisfying the nutritional needs of the consumer or patient for whom they are intended. Such proportions are well known in the art, and any conventional proportion can be used. In some embodiments, the nutritional compositions comprise a protein component in an amount of from about 0.5% to about 20% by weight, a carbohydrate component in an amount of from about 0.5% to about 65% by weight, and a fat component in an amount of from about 0.1% to about 25% by weight, these percents being based on the weight of the nutritional composition as a whole, with the particular balance of these macronutrients depending on the specific purpose and use of the nutritional composition.

[0029] In some embodiments of the nutritional composition, all of the protein component is provided by the protein system. In some embodiments, substantially all of the protein component is provided by the protein system. In some embodiments, a majority of the protein component is provided by the protein system.

[0030] All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.

[0031] The various embodiments of products of the present disclosure may also be substantially free of any optional or selected essential ingredient or feature described herein, provided that the remaining product still contains all of the required ingredients or features as described herein. In this context, and unless otherwise specified, the term "substantially free" means that the selected product contains less than a functional amount of the optional ingredient, typically less than about 1%), including less than about 0.5%>, including less than about 0.1 %, and also including zero percent, by weight of such optional or selected essential ingredient.

[0032] The products may comprise, consist of, or consist essentially of the essential elements of the products as described herein, as well as any additional or optional elements described herein or otherwise useful in nutritional product applications.

EXAMPLES

[0033] The following examples further describe and demonstrate embodiments within the scope of the present disclosure. The examples are given solely for the purpose of illustration and are not intended to otherwise limit the present disclosure, as many variations thereof are possible without departing from the spirit and scope of the disclosure. [0034] Table 1 illustrates the essential Amino Acid Profile recommendations according to the FNB/IOM Pattern 2005 and the FAO/WHO/UNU Pattern Adult 2007, as well as the amino acid profile of select proteins in mg/g of protein.

Table 1

[0035] Tables 2 and 3 illustrate non-dairy proteins which, when combined with certain other non-dairy proteins within a protein system, do not display the off-notes (Table 4) typical to the individual proteins.

Table 2

Table 3 Table 4

[0036] Table 5 illustrates the amino acid profile of five embodiments (1-5) of protein systems encompassed by the present disclosure as compared to (1) the amino acid profile guidelines set forth in the FNB/IOM Pattern 2005, (2) the amino acid profile guidelines as set forth in the FAO/WHO/UNU Pattern Adult 2007, and (3) bovine milk protein in mg/13 g of protein. Example 1 includes a protein system consisting of 60% dairy protein and 40% of a combination of mycoprotein and wheat proteins. Example 2 includes a protein system consisting of 60% milk protein concentrate and 40% wheat protein. Example 3 includes a protein system consisting of 50% milk protein concentrate and 50% soy protein. Example 4 includes a protein system consisting of 50% milk protein concentrate and 50% canola protein. Example 5 includes a protein system consisting of 60% milk protein concentrate, 30% wheat protein, and 10% collagen protein.

Table 5

[0037] All percentages, parts, and ratios as used herein pertain to listed ingredients and are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

[0038] Unless otherwise indicated herein, all sub-embodiments and optional embodiments are respective sub-embodiments and optional embodiments to all embodiments described herein. While the present disclosure has been illustrated by the description of embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the disclosure, in its broader aspects, is not limited to the specific details, the representative . .-— ^onnuiations, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the general disclosure herein.