BACKGROUND

There are a number of products that purport to provide an individual with physical and mental benefits when consumed. These products are often packaged as solid snack foods or as drinks and are consumed by individuals wanting to obtain nutritional value from the product to supplement their diet. These individuals may also maintain their physical energy and mental alertness in particular situations, such as students and athletes.

However, these products may include undesirable amounts of Calories due to, for example, the inclusion of sugars, and/or may provide an unpleasant taste and/or may fail to provide sufficient physical and mental benefits for an adequate period of time.

Moreover, consumers continually desire palatable, unique and healthy formulations. Accordingly, there is a need for improved edible compositions that provide consumers with benefits such as, additional nutritional value or increased energy and alertness.

SUMMARY

The disclosure relates to a composition that includes

a protein preparation, at least one methylated xanthine, at least two cholines;

taurine, phosphoric acid; a vitamins including vitamin B6, vitamin B12, niacin, folic acid phenylalanine and tyrosine and combinations thereof; and an organic acid selected from the group consisting of malic acid and citric acid DETAILED DESCRIPTION

It is to be understood that the disclosed embodiments are merely exemplary and details disclosed herein are not to be interpreted as limiting, but merely as a

representative basis for teaching one skilled in the art.

The present disclosure relates to compositions that provide protein. The disclosure also relates to compositions that provide energy .

In preferred embodiments, compositions according to the disclosure provide both energy and protein.

In preferred embodiments, compositions according to the disclosure provide at least one methylated xanthine and protein. In further embodiments, compositions according to the disclosure include a methylated xanthine, at least one choline and protein.

The disclosure relates to a stable, edible composition. The compositions

disclosed herein may be in liquid or solid form or include both liquid and solid forms. In preferred embodiments, the composition is provided as a liquid such as a dietary supplement, drink, beverage or gel. The liquid compositions may also have a

suspension of one or more components of the composition. The liquid compositions may be served at a wide range of temperatures from freezing (0°C) to up to about 90° C. Compositions may be provided in any mass or volume. The compositions may also be provided as a solid food item in the form of bars, crackers, cookies or similar products, having the mass and shape of these types of products.

Compositions according to the disclosure may be used as dietary supplements that provide further nutritional value and supplement an individual's diet. The compositions of the disclosure may increase the total dietary intake of certain dietary substances such as, but not limited to, vitamins, protein or amino acids. Compositions of the disclosure provide protein such that an individual may supplement the daily intake of protein. In preferred embodiments, the protein

originates, is obtained, is isolated or is derived from a biological source. In other embodiments, the protein may be synthesized in vitro and added to the composition. The protein preparation may be modified after isolation or purification from its source. For example, the protein preparation may be treated to improve solubility or to increase homogeneity with respect to molecular weight of the polypeptides.

As used herein, protein refers to preparations that include polypeptides, including low molecular weight polypeptides to very high molecular weight polypeptides. In a preferred embodiment, the protein is obtained, isolated or derived from a biological source. In preferred embodiments, the preparations may originate, be derived from or isolated from animal or vegetable sources. In particularly preferred embodiments, the preparation contains protein derived from at least one animal source and at least one vegetable source. In preferred embodiments, protein is derived from milk. In

particularly preferred embodiments, the protein is derived from whey. The protein may be obtained, isolated, purified or derived from whey. For example, the protein may be included in whey isolates that are added to a composition of the disclosure. In preferred embodiments, the whey isolate is largely free of non-protein molecules. The whey may be obtained from milk of a number of animal sources. In particularly

preferred embodiments, the whey isolate originates from a bovine source. The whey may also be derived from plant sources such as, but not limited to, soy milk. In

preferred embodiments, a vegetable source of protein is potato. In particularly

preferred embodiments, compositions of the disclosure include a combination both whey and potato isolates that provide protein.

In some embodiments, the protein preparation may be a highly purified preparation of a single polypeptide species. In preferred embodiments, the protein preparation is a mixture of polypeptide species. In some embodiments, a protein preparation may also include other constituents such as carbohydrate or fat molecules. In some embodiments, the protein preparations may include glycoproteins, lipoproteins or other modified polypeptides, including phosphorylated polypeptides. In preferred embodiments, compositions according to the disclosure provide from about 5 grams of protein to about 100 grams of protein per serving. In further

embodiments, compositions according to the disclosure have from about 10 grams of protein to about 50 grams of protein per serving. In further embodiments, compositions according to the disclosure have from about 15 grams of protein to about 30 grams of protein per serving. In preferred embodiments, the composition contains about 21 g of protein per serving.

In some embodiments, compositions according to the disclosure provide about 10% to about 100% of the recommended daily requirement for protein for a particular individual. In other embodiments, compositions according to the disclosure provide about 25% to about 75% of the daily requirement for protein. In preferred embodiments, the compositions provide about 25% to about 50% of the full recommended daily requirement for protein.

The volume of compositions according to the disclosure may be from about 50 ml to about 500 ml. In further embodiments, the volume of a composition which includes protein may be from about 100 ml to about 300 ml. In yet further embodiments, the volume of a composition which includes protein may be from about 100 ml to about 200 ml.

Compositions according to the disclosure may have from about 0.01 grams per ml to 2.00 grams per ml of protein. In further embodiments, compositions according to the disclosure may have from about 0.02 grams per ml to 1.00 grams per ml of protein. In a particularly preferred embodiment, a composition of the disclosure includes about 21 g of protein in about 6 fluid ounces (177 ml).

In preferred embodiments, compositions according to the disclosure may deliver a total of from about 10 kcal to about 300 kcal (about 10 to 300 Calories). In preferred embodiments, a compositions of the disclosure may deliver a total of from about 50 kcal to about 200 kcal per serving. In preferred embodiments, compositions of the

disclosure may deliver a total of from about 75 kcal to about 150 kcal. In preferred embodiments, a composition with protein has about 100 kcal (or about 100 Calories). Compositions according to the disclosure deliver about 0.02 kcal/ml to about 6.0 kcal/ml. In further embodiments, compositions according to the disclosure deliver deliver about 0.1 kcal/ml to about 4.0 kcal/ml

In preferred embodiments, the addition of protein results in the addition of less than about 5 g of carbohydrates and less than about 2 g of sugars per serving. In further preferred embodiments the composition has less than about 3 g of carbohydrates and about 1 g of sugars per serving.

In particularly preferred embodiments, compositions according to the disclosure include an energy component. Compositions according to the disclosure may counter, reduce or prevent drowsiness. The compositions may also provide a feeling of alertness and mental acuity. The composition may also provide a significant increase in the power of attention, continuity of attention, quality of working memory, quality of episodic memory, speed of memory and self-related alertness, the sum of the benefits providing a perceived feeling of energy.

In most embodiments, the energy component includes at least one methylated xanthine. Methylated xanthines include but are not limited to caffeine, theobromine, aminophylline, theophylline and paraxanthine. In some embodiments, the methylated xanthine is present in an amount from about 0.016% to about 0.5 % by weight (i.e. w/w) (or for some liquid forms from about 0.016 mg/ml to about 5.0 mg/ml). In another embodiment, the methylated xanthine is present in an amount from about 0.05 % to about 0.45% w/w (or from about 0.05 mg/ml to about 4.5 mg/ml). In still other embodiments, the methylated xanthine is present in an amount from about 0.10 % to about 0.39% (or from about 0.10 mg/ml to about 3.9 mg/ml) or the methylated xanthine is present in an amount from about 0.08 % to about 0.34 % by weight (or from about 0.8 mg/ml to about 3.4 mg/ml). In further embodiments, the methylated xanthine may be present from 0.002 mg/ml to about 0.02 mg/mt. In further embodiments, the the methylated xanthine may be present from 0.008 mg/ml to about 0.015 mg/ml. Compositions of the disclosure may also include a choline. The term choline when used herein refers to salts, metabolites, derivatives, structurally similar molecules or modifications of choline. Salts of choline including, by way of example only and without limitation, choline bitartrate, choline acetate, choline hydroxide or choline chloride. The term choline also refers to metabolites of choline. The term also encompasses citicoline (5'CDP-choline), betaine, acetylcholine, phosphatidylcholine or phosphorylated choline molecules. The term refers to both naturally (in vivo) synthesized or chemically (in vitro ) synthesized forms of choline or combinations of both natural and chemically synthesized forms. In some embodiments, a natural form of choline may be chemically modified in vitro to produce a desired molecule

In some embodiments, compositions according to the disclosure may have more than one choline. The compositions may have two different cholines, three different cholines , or as many as four different cholines. For example, compositions may utilize citicoline and a salt of choline. In preferred embodiments, compositions according to the disclosure utilize citicoline and choline bitartrate. The cholines may be present in equal proportions or one choline may be present in larger amounts than other cholines.

In one embodiment, one or more cholines are present from about 0.1% to 0.5%. In one embodiment, choline is present in an amount from about 0.0015% to about 0.09% by weight or from about 0.000015 g/ml to about 0.0009 g/ml. In another embodiment, choline is present in an amount from about 0.01 % to about 0.07% by weight or from about 0.1 mg/ml to about 0.7 mg/ml. In still another embodiment, the choline is present in an amount from about 0.013% to about 0.06% by weight (or from about 0.13 mg/ml to about 0.6 mg/ml). In still another embodiment, the choline

derivative is present in an amount from about 0.005% to about 0.019% (or from about 0.05 mg/ml to about 0.19 mg/ml).

In preferred embodiments, compositions according to the disclosure may include two or more cholines. In preferred embodiments, compositions according to the disclosure include citicoline and choline bitartrate. In preferred embodiments, the composition has from about 1 mg ml of choline bitartrate to about 4 mg/ml or from about 0.1% to 0.4% by weight. .Citicoline may be present 0.0002% to about 0.09% by weight In one embodiment, the composition may have from about 200 mg to about 500 mg of choline bitartrate in six (6) fluid ounces. The composition may have about 5 to about 30 mg of citicoline in addition to the choline bitartrate.

According to a preferred embodiment, the composition may further include one or more amino acids including, without limitation, precursors, structurally-similar compounds and analogs, metabolites, salts, esters or isomeric forms of amino acids. In preferred embodiments, the amino acids include, but are not limited to, N-acetyl L- tyrosine, tyrosine and phenylalanine. In one embodiment, amino acids are present in an amount from 0.016% to 5.0% by weight or from about 0.16 mg /ml to about 50 mg/ml. In one embodiment, amino acids are present in an amount from about 0.1 % to about 4% by weight (or from about 1.0 mg/ml to about 40.0 mg/ml). In still another embodiment, amino acids are present in an amount from about 0.3% to about 3% by weight (or from about 3.0 mg/ml to about 30 mg/ml). Examples of other amino acids that may be used, without limitation, include theanine, glutamic acid, alanine and (3- alanine.

In preferred embodiments, the edible composition includes N-acetyl L-tyrosine in an amount from about 0.03% to about 0.8% by weight (or about 0.3 mg/ml to about 8 mg/ml). In another embodiment, N-acetyl L-tyrosine is present in an amount from 0.06% to about 0.6% (or from about 0.6 mg/ml to about 6.0 g/ml). In still another embodiment, N-acetyl L-tyrosine is present in an amount from about 0.1% to about 0.5% by weight (or from about 1.0 mg/ml to about 5.0 mg/ml).

The composition may also include phenylalanine. In one embodiment, L- phenylalanine is present in an amount from about 0.03% to about 0.8% by weight (or from about 0.3 mg/ml to about 8.0 mg/ml). In one embodiment, L-phenylalanine is present in an amount from about 0.07% to about 0.6% by weight (or from about 0.7 mg/ml to about 6.0 g/ml). In still another embodiment, L-phenylalanine is present in an amount from about 0.03% to about 0.5% (or about 0.3 mg/ml to about 5.0 mg/ml). According to some embodiments, taurine is included in compositions of the disclosure, including derivatives, precursors, structurally-similar compounds, analogs or metabolites. In one embodiment, taurine is present in an amount from about 0.06% to about 1.6 % by weight (or from about 0.6 mg/ml to about 16.0 mg/ml). In one

embodiment, taurine is present in an amount from about 0.13 % to about 1.2 % by weight (or from about 1.3 mg/ml to about 12.0 mg/ml). In still another embodiment, taurine is present in an amount from about 0.2 % to about 1.0 % (or from about 2.0 mg/ml to about 10 mg/ml).

The composition may include at least one vitamin. For example, the composition may include vitamin B6. Vitamin B6, in its various forms, is involved in more than 100 enzymatic reactions involved in amino acid metabolism and the metabolism of one- carbon units, carbohydrates, and lipids.

In some embodiments, the composition includes vitamin B12. Vitamin B12 exists in several forms containing the mineral cobalt, e.g. methylcobalamin and 5- deoxyadenosylcobalamin. The composition may include niacin, also known as nicotinic acid or vitamin B3 and derivatives of niacin, including precursors, structurally related compounds; analogs and metabolites, including niacinamide.

In preferred embodiments, compositions according to the disclosure may include vitamin B6. In one embodiment, the B6 is present in an amount from about 0.003 % to about 0.3 %( or from about 0.03 mg/ml to about 3.0 mg/ml). In another embodiment, the vitamin B6 is present in an amount from about 0.01 % to about 0.2 % (or from about 0.1 mg/ml to about 2.0 mg/ml). In still another embodiment, the vitamin B6 is present in an amount from about 0.02 % to about 0.09 % (or from about 0.2 mg/ml to about 0.9 mg/ml). The composition may provide from about 20% to about 3000% of the recommended daily allowance of vitamin B6. In preferred embodiments, compositions according to the disclosure may include vitamin B12. In one embodiment, the B12 is present in an amount from about 0.00003 % to about 0.003 % (or from about 0.000003 g/ml to about 0.00003 g/ml). In another embodiment, the B12 is present in an amount from about 0.0001 % to about 0.002 % (or from about 0.00001 g/ml to about 0.00002 g/mi). In still another embodiment, the B12 is present in an amount from about 0.0002 % to about 0.001 % (or from about 0.000002 g/ml to about 0.00001 g/ml). The composition may provide from about 20% to about 10000% of the recommended daily allowance of vitamin B12.

In preferred embodiments, compositions according to the disclosure may include niacin, which includes niacinamide. In some embodiments, niacin is present in an amount from about 0.000003 % to about 0.3 % (or from about 0.00003 mg/ml or from about 3.0 mg/ml). In further embodiments the niacin is present in an amount from about 0.003 % to about 0.3 % (or about 0.003 mg/m! to about 3.0 g/ml). In another embodiment, the niacin is present in an amount from about 0.01 % to about 0.2 % (or about 0.1 mg/ml to about 2.0 mg/ml). In still another embodiment, the niacin is present in an amount from about 0.02 % to about 0.09 % (or about 0.2 mg/ml to about 0.9 mg/ml). The composition may provide from about 7% to about 300% of the

recommended daily allowance of niacin.

The energy composition may include folic acid. In some embodiments, folic acid is present in an amount from about 0.000003% to about 0.02 % (or about 0.00003 mg/ml to about 0.2 mg/ml). In further embodiments, folic acid is present in an amount from about 0.00016 % to about 0.02 % (or about 0.0016 mg/ml to about 0.2 mg/ml). In another embodiment, the folic acid is present in an amount from about 0.0003 % to about 0.008 % (or about 0.003 mg/ml to about 0.08 mg/ml). In still further embodiments the folic acid is present in an amount from about 0.0006 % to about 0.004 % (or about 0.006 mg/ml to about 0.04 mg/ml). The composition may provide from about 10% to about 100% of the recommended daily allowance of folic acid. In further embodiments, compositions of the disclosure include additional components that may reduce fatigue and provide energy. Such additional components may include, for example, one or more of glucuronolactone, glucono delta-lactone, and glucuronic acid. In one embodiment, glucuronolactone is present in an amount from about 0.03% to about 1.2 % (or from about 0.3 mg/ml to about 0. 12 mg/ml). In a further embodiment, glucuronolactone is present in an amount from about 0.0003 to about 0.09 %. (or from about 0.003 mg/ml to about 0.9 mg/ml). In still another

embodiment, glucuronolactone is present in an amount from about 0.05 % to about 0.7 % (or from about 0.0016 g g/ml to about 0.007 g/ml).

(n one embodiment, the pH of the composition is from about 1.0 to about 9.0. In preferred embodiments, the pH of the composition is acidic. For example, the pH may be from about 2.0 to about 4.0. The energy composition may further include one or more pH-mod ^' rfying components. In one embodiment, the pH-mod ^' rfying components are acidulants. Suitable pH-modifying components include edible inorganic acids, such as phosphoric acid. In preferred embodiments, the composition includes edible organic acids. Preferred embodiments of edible organic acids include malic acid and citric acid.

In one embodiment, the pH-modifying components are present™ an amount from about 0.03% to about 1.2% or from about 0.0003 g/ml to about 0.012 g/ml. In one embodiment, the pH-modifying components are present in an amount from about 0.1% to about 0.9 % (or from about 0.001 to about 0.009 g/ml). In still another embodiment the pH-modifying components are present in an amount from about 0.13 to about 0.7 % (or from about 0.0013 g/ml to about 0.007 g/ml).

In one embodiment, there are a sufficient number of flavorants and/or

sweeteners so that unpalatable tasting components will be masked. In one embodiment, the flavorants are present in an amount from about 0.00003% to about 0.8 % (or about 0.00000003 g/ml to about 0.008 g/ml). In another embodiment, the flavorants are present in an amount from about 0.3% to about 0.8 %. According to the disclosure, nutritive or non-nutritive sweeteners may be added. [Examples of such sweeteners include, but are not limited to xyiitol, stevia, aspartame, sucralose and other non-nutritive sweeteners known to those of ordinary skill in the art. In preferred embodiments, sucralose may be used. In further embodiments, sucralose is present in an amount from 0.0003% to about 0.4 % (or about 0.003 mg/ml to about 4.0 mg/ml). In one embodiment, sucralose is present in an amount from about 0.016% to about 0.4 % (or about 0.16 mg/ml to about 4.0 mg/ml). In one embodiment, sucralose is present in an amount from about 0.026% to about 0.3 % (or about 0.26 mg/ml to about 3.0 mg/ml). In still another embodiment, sucralose is present in an amount from about 0.03 % to about 0.2 % (or about 0.3 mg/ml to about 2.0 mg/ml).

In some embodiments, preservative agents may be added to the composition. Ethylene diamine tetraacetic acid ("EDTA") may also be included to improve flavor and stability. In one embodiment, EDTA is present in an amount from about 0.0007 % to about 0.009 % (or about 0.000007 g/ml to about 0.00009 g/ml). In another embodiment, the EDTA is present in an amount from about 0.001 % to about 0.007 % (or about 0.01 mg/ml to about 0.07 mg/ml). In still another embodiment, the EDTA is present in an amount from about 0.0013 % to about 0.006 % (or about 0.013 mg/ml to about 0.06 mg/ml). In still another embodiment, the EDTA is present in an amount from about 0.0007 % to about 0.003 % (or about 0.007 mg/ml to about 0.03 mg/ml). The energy composition also includes one or more fruit flavorants. Such fruit flavorants include, but are not limited to lemon lime flavors, orange flavors, berry flavors, high fructose corn syrup, raspberry juice concentrates, berry juice concentrates and the like.

The energy composition may further include at least one preservative. In one embodiment, the preservative is a natural preservative. Embodiments of useful preservatives include, but are not limited to, benzoic acid and benzoic acid derivatives such as sodium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, and combinations thereof. The preservative may include sorbic acid derivatives such as potassium sorbate. In one embodiment, the preservative is present in an amount from about 0.003 % to about 1.0 % (or from about 0.00003 g/ml to about 0.01 g/ml). In one embodiment, the preservative is present in an amount from about 0.03 % to about 0.8 %. In preferred embodiments, the preservative is phosphoric acid. In a preferred the preservative is present from about 0.001% to about 5% by weight. In preferred embodiments, the phosphoric acid is present from about 0.02% to about 1% by weight In some embodiments, the composition may also include a bicarbonate, such as sodium bicarbonate. In preferred embodiments, phosphoric acid also acts as a processing aid. In yet further embodiments, phosphoric acid is flavorant.

In preferred embodiments, compositions of the disclosure may also include phosphoric acid as a preservative, processing aid and as a flavorant The phosphoric acid may be present from about 0.001% to about 5% by weight. In preferred

embodiments, the phosphoric acid is present from about 0.02% to about 1% by weight A composition of the disclosure may also include a bicarbonate, such as sodium bicarbonate.

In some embodiments, the protein-containing energy composition does not contain glucuronolactone or glucuronic acid. In some embodiments, the composition may have incidental or trace amounts of glucuronolactone or glucuronic acid that originates from other components such as protein isolates.

Table 1 provide a non-limiting set of components that may be introduced into a composition encompassed by this disclosure. The amounts provided in table 1 are particularly useful to form compositions having a total final volume of about 6 fluid ounces.

Table 1

It is to be understood that this disclosure is not limited to the embodiments described above as specific components and conditions may vary. Furthermore, the terminology used herein is used only for the purpose of describing particular embodiments and is not intended to be limiting in any way. The words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the disclosure.