FIELD

[0001] The present disclosure is directed generally to nutritional compositions and more particularly to powdered nutritional compositions containing at least one additive and forming a dispersion when mixed with a hot beverage thereby fortifying the beverage.

BACKGROUND

[0002] Hot beverages such as coffee and tea are typically poor sources of proteins and amino acids, as well as vitamins, minerals, nutrients and other key ingredients such as dietary fiber, green tea extract, β-glucan, β-hydroxy β-methylbutyrate (HMB), curcumin, turmeric root extract, docosahexanoic acid ("DHA"), and arachidonic acid ("ARA").

SUMMARY

[0003] The general inventive concepts contemplate compositions and methods for fortifying a hot beverage. By way of example to illustrate various aspects of the general inventive concepts, several exemplary embodiments of compositions and methods are disclosed herein.

[0004] In a first exemplary embodiment, the present disclosure is directed to a powdered nutritional composition for fortifying a hot beverage. The composition comprises a protein and at least one additive. The additive is selected from the group consisting of a free amino acid, green tea extract, β-glucan, β-alanine, β-hydroxy β-methylbutyrate (HMB), curcumin, turmeric root extract, DHA, ARA, a flavonoid, a carotenoid, mulberry leaf extract, ginseng, resveratrol, acai, a probiotic, grape seed extract, gingko biloba, ashwagandha, cardamom, ginger, lecithin, basil, lactoferrin, coenzyme Q ₁₀ , cinnamon, chondroitin sulphate, echinacea, glucosamine, milk thistle, salacia, lipoic acid, collagen, saw palmetto berries extract, ribose, a phytosterol, quercetin, yerba mate, omega-3 fatty acids and derivatives thereof, a phospholipid, citicholine, citicoline, isomaltulose, nicotinamide riboside, and combinations thereof. The powdered nutritional composition forms a dispersion when mixed with the hot beverage. [0005] In a second exemplary embodiment, the present disclosure is directed to the powdered nutritional composition according to the first exemplary embodiment described above comprising 5% to 95% by weight of the protein and 5% to 95% by weight of the at least one additive.

[0006] In a third exemplary embodiment, the present disclosure is directed to a powdered nutritional composition for fortifying a hot beverage. The composition comprises 10% to 60% by weight protein, 1% to 60%> by weight of at least one additive, and 1% to 40% by weight free amino acid. The additive is selected from the group consisting of green tea extract, β-glucan, β- alanine, β-hydroxy β-methylbutyrate (HMB), curcumin, turmeric root extract, DHA, ARA, an oil, a flavonoid, a carotenoid, mulberry leaf extract, ginseng, resveratrol, acai, a probiotic, grape seed extract, gingko biloba, ashwagandha, cardamom, ginger, lecithin, basil, lactoferrin, coenzyme Q ₁₀ , cinnamon, chondroitin sulphate, echinacea, glucosamine, milk thistle, salacia, caffeine, lipoic acid, collagen, a phytosterol, saw palmetto berries extract, ribose, guarana, quercetin, yerba mate, omega-3 fatty acids and derivatives thereof, a phospholipid, citicholine, citicoline, nicotinamide riboside, and combinations thereof. The powdered nutritional composition forms a dispersion when mixed with the hot beverage.

[0007] In a fourth exemplary embodiment, the present disclosure is directed to a powdered nutritional composition for increasing energy levels in a subject. The composition comprises 10%) to 60%) by weight hydro lyzed whey protein, 1% to 60% by weight free amino acid, and 1% to 6% by weight green tea catechin. The composition will also typically comprise 0% to 10% by weight vitamins, 0% to 20% by weight minerals, 0% to 40% by weight guarana, 0% to 60% by weight ribose, 0% to 40% by weight ginseng, 0% to 60% by weight isomaltulose, and 0% to 40% by weight yerba mate. The powdered nutritional composition forms a dispersion when mixed with a hot beverage.

[0008] This embodiment is also directed to a powdered nutritional composition for use in increasing energy levels in a subject, the composition comprising: 10% to 60% by weight hydro lyzed whey protein; 1% to 60% by weight free amino acid; 1% to 6% by weight green tea catechin; 0% to 10% by weight vitamins; 0% to 20% by weight minerals; 0% to 40% by weight guarana; 0% to 60% by weight ribose; 0%> to 40%> by weight ginseng; and 0%> to 40%> by weight yerba mate, wherein the composition forms a dispersion when mixed with a hot beverage.

[0009] This embodiment is also directed to use of a composition in the manufacture of a medicament for a powdered nutritional composition for increasing energy levels in a subject, the composition comprising: 10%> to 60%> by weight hydro lyzed whey protein; 1% to 60%> by weight free amino acid; 1% to 6%> by weight green tea catechin; 0%> to 10%> by weight vitamins; 0%> to 20%) by weight minerals; 0%> to 40%> by weight guarana; 0%> to 60%> by weight ribose; 0%> to 40%) by weight ginseng; and 0%> to 40%> by weight yerba mate, wherein the composition forms a dispersion when mixed with a hot beverage.

[0010] In a fifth exemplary embodiment, the present disclosure is directed to a powdered nutritional composition for improving or preserving heart health in a subject. The powdered nutritional composition comprises 10%> to 60%> by weight hydro lyzed whey protein, 5% to 40% by weight free amino acid, 3% to 6% by weight green tea catechin. The composition will also typically comprise 0% to 50% by weight β-glucan, 0% to 10% by weight vitamins; 0% to 20% by weight minerals, 0% to 50% by weight phytosterols; 0% to 50% by weight nicotinamide riboside, and 0% to 40% by weight omega-3 fatty acids. The powdered nutritional composition forms a dispersion when mixed with a hot beverage.

[0011] This embodiment is also directed to a powdered nutritional composition for use in improving or preserving heart health in a subject, the composition comprising: 10% to 60% by weight hydro lyzed whey protein; 5% to 40% by weight free amino acid; 3% to 6% by weight green tea catechin; 0% to 50% by weight β-glucan; 0% to 10% by weight vitamins; 0% to 20% by weight minerals; 0% to 50% by weight phytosterols; and 0% to 40% by weight omega-3 fatty acids, wherein the composition forms a dispersion when mixed with a hot beverage.

[0012] This embodiment is also directed to use of a composition in the manufacture of a medicament for a powdered nutritional composition for improving or preserving heart health in a subject, the composition comprising: 10% to 60% by weight hydro lyzed whey protein; 5% to 40%) by weight free amino acid; 3% to 6% by weight green tea catechin; 0% to 50% by weight β- glucan; 0% to 10% by weight vitamins; 0% to 20% by weight minerals; 0% to 50% by weight phytosterols; and 0% to 40% by weight omega-3 fatty acids, wherein the composition forms a dispersion when mixed with a hot beverage.

[0013] In a sixth exemplary embodiment, the present disclosure is directed to a powdered nutritional composition for reducing blood sugar spikes in a diabetic individual. The

composition comprises 10%> to 60%> by weight hydrolyzed whey protein, 5% to 40%> by weight free amino acid, 3% to 6% by weight green tea catechin. The composition also comprises 0% to 10% by weight vitamins, 0% to 5% by weight mineral chromium, and 0% to 22% by weight mulberry leaf extract. The composition forms a dispersion when mixed with a hot beverage.

[0014] This embodiment is also directed to a powdered nutritional composition for use in reducing blood sugar spikes in a diabetic individual, the composition comprising: 10%> to 60%> by weight hydrolyzed whey protein; 5% to 40%> by weight free amino acid; 3% to 6%> by weight green tea catechin; 0% to 10% by weight vitamins; 0% to 5% by weight mineral chromium; and 0% to 22% by weight mulberry leaf extract, wherein the composition forms a dispersion when mixed with a hot beverage.

[0015] This embodiment is also directed to use of a composition in the manufacture of a medicament for a powdered nutritional composition for reducing blood sugar spikes in a diabetic individual, the composition comprising: 10%> to 60%> by weight hydrolyzed whey protein; 5% to 40%) by weight free amino acid; 3% to 6% by weight green tea catechin; 0% to 10% by weight vitamins; 0% to 5% by weight mineral chromium; and 0% to 22% by weight mulberry leaf extract, wherein the composition forms a dispersion when mixed with a hot beverage.

[0016] In a seventh exemplary embodiment, the present disclosure is directed to a powdered nutritional composition suitable for improving or preserving muscle health in a subject. The composition comprises 30% to 85% by weight hydrolyzed whey protein, 10% to 35% by weight free amino acid, 3% to 6% by weight green tea catechin. The composition also comprises 0% to 10%) by weight vitamins, 0% to 20% by weight minerals, and 0% to 30% by weight calcium β- hydroxy β-methylbutyrate (Ca-HMB). The composition forms a dispersion when mixed with a hot beverage. [0017] This embodiment is also directed to a powdered nutritional composition for use in improving or preserving muscle health in a subject, the composition comprising: 30% to 85% by weight hydro lyzed whey protein; 10% to 35% by weight free amino acid; 3% to 6% by weight green tea catechin; 0% to 10% by weight vitamins; 0% to 20% by weight minerals; and 0% to 30% by weight calcium β-hydroxy β-methylbutyrate (Ca-HMB), wherein the composition forms a dispersion when mixed with a hot beverage.

[0018] This embodiment is also directed to use of a composition in the manufacture of a medicament for a powdered nutritional composition for improving or preserving muscle health in a subject, the composition comprising: 30% to 85% by weight hydrolyzed whey protein; 10% to 35%) by weight free amino acid; 3% to 6% by weight green tea catechin; 0% to 10% by weight vitamins; 0% to 20% by weight minerals; and 0% to 30% by weight calcium β-hydroxy β- methylbutyrate (Ca-HMB), wherein the composition forms a dispersion when mixed with a hot beverage.

[0019] In an eighth exemplary embodiment, the present disclosure is directed to a powdered nutritional composition suitable for use in fortifying a hot beverage. The composition comprises 0% to 95% by weight protein, tyrosine, phenylalanine, taurine, vitamin B3, vitamin B6, vitamin B9, and vitamin B12. The composition forms a dispersion when mixed with the hot beverage.

[0020] This embodiment is also directed to a powdered nutritional composition for fortifying a hot beverage, the composition comprising: 0% to 9% by weight protein; tyrosine, phenylalanine, taurine, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, wherein the composition forms a dispersion when mixed with the hot beverage.

[0021] In a ninth exemplary embodiment, the present disclosure is directed to a powdered nutritional composition suitable for use in fortifying a hot beverage. The composition comprises 0%) to 95% by weight protein, 0% to 95% by weight free amino acid, 0% to 80% by weight green tea extract, 0% to 40% by weight vitamins, 0% to 50% by weight minerals, 0% to 40% by weight sweeteners, 0% to 10% by weight emulsifier, 0% to 10% by weight stabilizer, and at least one additive. The additive is selected from the group consisting of green tea extract, β-glucan, β- alanine, β-hydroxy β-methylbutyrate (HMB), dietary fiber, curcumin, turmeric root extract, DHA, ARA, a marine oil, a plant oil, an animal oil, a flavonoid, a carotenoid, mulberry leaf extract, ginseng, resveratrol, acai, a probiotic, grape seed extract, gingko biloba, ashwagandha, cardamom, ginger, lecithin, basil, lactoferrin, coenzyme Q10, cinnamon, chondroitin sulphate, echinacea, glucosamine, milk thistle, salacia, caffeine, lipoic acid, collagen, a phytosterol, saw palmetto berries extract, ribose, guarana, quercetin, yerba mate, omega-3 fatty acids and derivatives thereof, a phospholipid, citicholine, citicoline, nicotinamide riboside, and

combinations thereof. The composition is not oil based. The composition typically forms a dispersion when mixed with the beverage having a temperature of 90 °F to 212 °F without substantially altering a color of the beverage.

[0022] This embodiment is also directed to a powdered nutritional composition suitable for fortifying a hot beverage, the composition comprising: 0% to 95% by weight protein; 0%> to 95% by weight free amino acid; 0% to 80% by weight green tea extract; 0% to 40% by weight vitamins; 0%> to 50%> by weight minerals; 0%> to 40%> by weight sweeteners; 0%> to 10%> by weight emulsifier; 0%> to 10%> by weight stabilizer; and at least one additive selected from the group consisting of green tea extract, β-glucan, β-alanine, β-hydroxy β-methylbutyrate (HMB), dietary fiber, curcumin, turmeric root extract, DHA, ARA, a marine oil, a plant oil, an animal oil, a flavonoid, a carotenoid, mulberry leaf extract, ginseng, resveratrol, acai, a probiotic, grape seed extract, gingko biloba, ashwagandha, cardamom, ginger, lecithin, basil, lactoferrin, coenzyme Q10, cinnamon, chondroitin sulphate, echinacea, glucosamine, milk thistle, salacia, caffeine, lipoic acid, collagen, a phytosterol, saw palmetto berries extract, ribose, guarana, quercetin, yerba mate, omega-3 fatty acids and derivatives thereof, a phospholipid, citicholine, citicoline, nicotinamide riboside, and combinations thereof, wherein the composition is not oil based; and wherein the composition forms a dispersion when mixed with the beverage having a temperature of 90°F to 212°F without substantially altering a color of the beverage.

[0023] In a tenth exemplary embodiment, the present disclosure is directed to a method of fortifying a hot beverage. The method comprises providing the beverage at a temperature of 90 °F to 212 °F and mixing a nutritional composition with the beverage. The nutritional

composition comprises a protein and a plurality of additives. The plurality of additives are selected from the group consisting of green tea extract, β-glucan, mulberry leaf extract, β- hydroxy β-methylbutyrate (HMB), a free amino acid, and combinations thereof. [0024] In a further embodiment, the present disclosure is directed to a beverage comprising a composition as defined in the present disclosure. The beverage is preferably hot.

[0025] In an exemplary embodiment, the beverage is coffee or tea. In an exemplary embodiment, the beverage contains caffeine or is substantially free of caffeine. In an exemplary embodiment, the beverage has a temperature of 90 °F to 212 °F. In an exemplary embodiment, the beverage has a temperature of 125 °F to 185 °F.

[0026] In an exemplary embodiment, a fortification of the beverage with the composition does not substantially alter a color of the beverage. In an exemplary embodiment, a fortification of the beverage with the composition does not substantially lighten a color of the beverage. In an exemplary embodiment, a fortification of the beverage with the composition does not substantially alter an astringency of the beverage. In an exemplary embodiment, a fortification of the beverage with the composition does not substantially reduce an astringency of the beverage.

[0027] In an exemplary embodiment, the powdered nutritional composition contains no more than 1% by weight of oil.

[0028] In an exemplary embodiment, the powdered nutritional composition further comprises a vitamin. In an exemplary embodiment, the vitamin is selected from the group consisting of Vitamin A, Vitamin B, Vitamin C, Vitamin D, Vitamin E, Vitamin K, and combinations thereof.

[0029] In an exemplary embodiment, the powdered nutritional composition further comprises a mineral. In an exemplary embodiment, the mineral is selected from the group consisting of calcium, phosphorus, potassium, sulfur, sodium, chlorine, magnesium, iron, cobalt, copper, zinc, molybdenum, iodine, selenium, manganese, chromium, fluorine, boron, lithium, strontium, and combinations thereof.

[0030] In an exemplary embodiment, the powdered nutritional composition further comprises a sweetener. In an exemplary embodiment, the sweetener is a natural sweetener. In an exemplary embodiment, the natural sweetener is selected from the group consisting of stevia, stevioside, thaumatin, pentadin, monellin, miraculin, brazzein, curculin, glycyrrhizin, luo han guo, erythritol, glycerol, inulin, isomalt, lactitol, mabinlin, maltitol, mannitol, pentadin, sorbitol, tagatose, xylitol, mogroside, and combinations thereof. In an exemplary embodiment, the sweetener is an artificial sweetener. In an exemplary embodiment, the artificial sweetener is selected from the group consisting of acesulfame potassium, alitame, aspartame, sodium cyclamate, dulcin, glucin, neotame, saccharin, sucralose, and combinations thereof.

[0031] In an exemplary embodiment, the powdered nutritional composition further comprises flavorant. In an exemplary embodiment, the flavorant is a natural flavor. In an exemplary embodiment, the flavorant is an artificial flavor.

[0032] In an exemplary embodiment, the powdered nutritional composition further comprises colorant. In an exemplary embodiment, the colorant is a natural color. In an exemplary embodiment, the colorant is an artificial color.

[0033] In an exemplary embodiment, the powdered nutritional composition further comprises an emulsifier. In an exemplary embodiment, the emulsifier is selected from the group consistinj of lecithin, mono-glycerides, di-glycerides, monosodium phosphate derivatives of mono- glycerides, monosodium phosphate derivatives of di-glycerides, glyceryl monooleate, glyceryl monostearate, diacetyle tartaric acid esters of mono-glycerides, diacetyle tartaric acid esters of di-glycerides, polysorbate 80, polysorbate 60, polysorbate 65, propylene glycol, and

combinations thereof.

[0034] In an exemplary embodiment, the powdered nutritional composition further comprises stabilizer. In an exemplary embodiment, the stabilizer is selected from the group consisting of gum Arabic, agar-agar, ammonium alginate, calcium alginate, potassium alginate, carob bean gum, ghatti gum, guar gum, chondrus extract, sterculia gum, gellan gum, sodium stearoyl lactylate, xanthan gum, and combinations thereof.

[0035] In an exemplary embodiment, the powdered nutritional composition further comprises dietary fiber. In an exemplary embodiment, the dietary fiber is resistant starch from one of wheat and corn.

[0036] In an exemplary embodiment, the powdered nutritional composition comprises a probiotic selected from the group consisting of Lactobacillus acidophilus, Acidophilus bifidus, and Bifidobacteria. [0037] In an exemplary embodiment, the powdered nutritional composition comprises β-glucan from a cereal. In another exemplary embodiment, the β-glucan is from a microorganism.

[0038] In an exemplary embodiment, the powdered nutritional composition comprises calcium β-hydroxy β-methylbutyrate (Ca-HMB).

[0039] In an exemplary embodiment, the powdered nutritional composition further comprises one of a marine oil, a plant oil, and an animal oil. In an exemplary embodiment, the marine oil is selected from the group consisting of omega-3 unsaturated fatty acids, omega-6 unsaturated fatty acids, salmon oil, herring oil, mackerel oil, anchovy oil, sardine oil, tuna oil, swordfish oil, cod oil, krill oil and combinations thereof. In another exemplary embodiment, the plant oil is selected from the group consisting of coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, mustard oil, almond oil, beech nut oil, cashew oil, borage seed oil, flaxseed oil, and combinations thereof. In an exemplary embodiment, the animal oil is selected from the group consisting of butter, lard, butter oil, and combinations thereof.

[0040] In an exemplary embodiment, the powdered nutritional composition comprises caffeine.

[0041] In an exemplary embodiment, the protein of the powdered nutritional composition is intact protein. In an exemplary embodiment, the protein is hydrolyzed protein. In an exemplary embodiment, the protein is a combination of intact protein and hydrolyzed protein.

[0042] In an exemplary embodiment, the free amino acid of the powdered nutritional composition is selected from the group consisting of tyrosine, phenylalanine, taurine, valine, leucine, isoleucine, alanine, arginine, glutamine, lysine, aspartic acid, glutamic acid, proline, cysteine, ornithine, selenocysteine, threonine, methionine, histidine, tryptophan, asparagine, glycine, serine, and combinations thereof.

[0043] In an exemplary embodiment, a serving size of the powdered nutritional composition is from 1 g to 25 g. In an exemplary embodiment, a serving size of the powdered nutritional composition is from 5 g to 12 g. [0044] In an eleventh exemplary embodiment, the present disclosure is directed to a nutritional composition for fortifying a hot beverage. The composition comprises a free amino acid; at least one B vitamin; and at least one additive selected from the group consisting of protein, green tea extract, β-glucan, β-alanine, β-hydroxy β-methylbutyrate (HMB), curcumin, turmeric root extract, DHA, ARA, a flavonoid, a carotenoid, mulberry leaf extract, ginseng, resveratrol, acai, a probiotic, grape seed extract, gingko biloba, ashwagandha, cardamom, ginger, lecithin, basil, lactoferrin, coenzyme Q ₁₀ , cinnamon, chondroitin sulphate, echinacea, glucosamine, milk thistle, salacia, lipoic acid, collagen, a phytosterol, saw palmetto berries extract, ribose, guarana, quercetin, yerba mate, omega-3 fatty acids and derivatives thereof, a phospholipid, citicholine, citicoline, isomaltulose, nicotinamide riboside, and combinations thereof. The nutritional composition forms a dispersion when mixed with the hot beverage.

[0045] In an exemplary embodiment, the free amino acid comprises 10% to 70% by weight of the composition. In an exemplary embodiment, the free amino acid is selected from the group consisting of tyrosine, phenylalanine, taurine, valine, leucine, isoleucine, alanine, arginine, glutamine, lysine, aspartic acid, glutamic acid, proline, cysteine, ornithine, selenocysteine, threonine, methionine, histidine, tryptophan, asparagine, glycine, serine, and combinations thereof.

[0046] In an exemplary embodiment, the at least one B vitamin comprises 2% to 40% by weight of the composition. In an exemplary embodiment, the at least one B vitamin is selected from the group consisting of thiamine (Bl), riboflavin (B2), niacin (B3), niacineamide (B3), pantothenic acid (B5), pyridoxine (B6), pyridoxamine (B6), pyridoxal (B6), biotin (B7), folic acid (B9), folinic acid (B9), cyanocobalamin (B12), hydroxycobalamin (B12), methylcobalamin (B12), and combinations thereof.

[0047] In a further exemplary embodiment, the nutritional composition comprises a plurality of B vitamins selected from the group consisting of thiamine (Bl), riboflavin (B2), niacin (B3), niacineamide (B3), pantothenic acid (B5), pyridoxine (B6), pyridoxamine (B6), pyridoxal (B6), biotin (B7), folic acid (B9), folinic acid (B9), cyanocobalamin (B12), hydroxycobalamin (B12), methylcobalamin (B12), and combinations thereof. [0048] In an exemplary embodiment, the at least one additive comprises 1% to 60% by weight of the composition.

[0049] In an exemplary embodiment, the beverage is coffee. In an exemplary embodiment, the beverage is tea.

[0050] In an exemplary embodiment, the beverage contains caffeine. In an exemplary embodiment, the beverage contains 20 mg/serving to 400 mg/serving of caffeine.

[0051] In an exemplary embodiment, the beverage is substantially free of caffeine.

[0052] In an exemplary embodiment, the composition contains no more than 1% by weight of oil.

[0053] In an exemplary embodiment, fortification of the beverage with the composition does not substantially alter a color of the beverage. In an exemplary embodiment, fortification of the beverage with the composition does not substantially lighten a color of the beverage.

[0054] In an exemplary embodiment, fortification of the beverage with the composition does not substantially alter an astringency of the beverage. In an exemplary embodiment, fortification of the beverage with the composition does not substantially reduce an astringency of the beverage.

[0055] In an exemplary embodiment, the beverage has a temperature of 90 °F to 212 °F. In an exemplary embodiment, the beverage has a temperature of 125 °F to 185 °F.

[0056] In an exemplary embodiment, the nutritional composition further comprises a non-B vitamin. In an exemplary embodiment, the non-B vitamin is selected from the group consisting of Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin K, and combinations thereof.

[0057] In an exemplary embodiment, the nutritional composition further comprises a mineral. In an exemplary embodiment, the mineral is selected from the group consisting of calcium, phosphorus, potassium, sulfur, sodium, chlorine, magnesium, iron, cobalt, copper, zinc, molybdenum, iodine, selenium, manganese, chromium, fluorine, boron, lithium, strontium, and combinations thereof. [0058] In an exemplary embodiment, the nutritional composition further comprises a sweetener. In an exemplary embodiment, the sweetener is a natural sweetener. In an exemplary embodiment, the natural sweetener is selected from the group consisting of stevia, stevioside, thaumatin, pentadin, monellin, miraculin, brazzein, curculin, glycyrrhizin, luo han guo, erythritol, glycerol, inulin, isomalt, lactitol, mabinlin, maltitol, mannitol, pentadin, sorbitol, tagatose, xylitol, mogroside, and combinations thereof. In an exemplary embodiment, the sweetener is an artificial sweetener. In an exemplary embodiment, the artificial sweetener is selected from the group consisting of acesulfame potassium, alitame, aspartame, sodium cyclamate, dulcin, glucin, neotame, saccharin, sucralose, and combinations thereof.

[0059] In an exemplary embodiment, the nutritional composition further comprises a flavorant. In an exemplary embodiment, the flavorant is a natural flavor. In an exemplary embodiment, the flavorant is an artificial flavor.

[0060] In an exemplary embodiment, the nutritional composition further comprises a colorant. In an exemplary embodiment, the colorant is a natural color. In an exemplary embodiment, the colorant is an artificial color.

[0061] In an exemplary embodiment, the nutritional composition further comprises an emulsifier. In an exemplary embodiment, the emulsifier is selected from the group consisting of lecithin, mono-glycerides, di-glycerides, monosodium phosphate derivatives of mono-glycerides, monosodium phosphate derivatives of di-glycerides, glyceryl monooleate, glyceryl

monostearate, diacetyle tartaric acid esters of mono-glycerides, diacetyle tartaric acid esters of di-glycerides, polysorbate 80, polysorbate 60, polysorbate 65, propylene glycol, and

combinations thereof.

[0062] In an exemplary embodiment, the nutritional composition further comprises a stabilizer. In an exemplary embodiment, the stabilizer is selected from the group consisting of gum Arabic, agar-agar, ammonium alginate, calcium alginate, potassium alginate, carob bean gum, ghatti gum, guar gum, chondrus extract, sterculia gum, gellan gum, sodium stearoyl lactylate, xanthan gum, and combinations thereof. [0063] In an exemplary embodiment, the nutritional composition further comprises dietary fiber. In an exemplary embodiment, the dietary fiber is resistant starch from one of wheat and corn.

[0064] In an exemplary embodiment, the nutritional composition comprises a probiotic selected from the group consisting of Lactobacillus acidophilus, Acidophilus bifidus, and Bifidobacteria.

[0065] In an exemplary embodiment, the nutritional composition comprises β-glucan from a cereal. In an exemplary embodiment, the nutritional composition comprises β-glucan from a microorganism.

[0066] In an exemplary embodiment, the nutritional composition comprises calcium β-hydroxy β-methylbutyrate (Ca-HMB).

[0067] In an exemplary embodiment, the nutritional composition comprises at least one of a marine oil, a plant oil, and an animal oil. In an exemplary embodiment, the marine oil is selected from the group consisting of omega-3 unsaturated fatty acids, omega-6 unsaturated fatty acids, salmon oil, herring oil, mackerel oil, anchovies oil, sardines oil, tuna oil, swordfish oil, cod oil, krill oil and combinations thereof. In an exemplary embodiment, the plant oil is selected from the group consisting of coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, mustard oil, almond oil, beech nut oil, cashew oil, borage seed oil, flaxseed oil, and combinations thereof. In an exemplary embodiment, the animal oil is selected from the group consisting of butter, lard, butter oil, and combinations thereof.

[0068] In an exemplary embodiment, the nutritional composition comprises β-alanine. [0069] In an exemplary embodiment, the nutritional composition comprises β-carotene. [0070] In an exemplary embodiment, the nutritional composition comprises lycopene. [0071] In an exemplary embodiment, the nutritional composition comprises lutein.

[0072] In an exemplary embodiment, the nutritional composition comprises zeaxanthin. [0073] n an exemplary embodiment, the nutritional composition comprises mulberry leaf extract.

[0074] n an exemplary embodiment, the nutritional composition comprises ginseng,

[0075] n an exemplary embodiment, the nutritional composition comprises resveratrol.

[0076] n an exemplary embodiment, the nutritional composition comprises acai.

[0077] n an exemplary embodiment, the nutritional composition comprises grape seed extract,

[0078] n an exemplary embodiment, the nutritional composition comprises gingko biloba.

[0079] n an exemplary embodiment, the nutritional composition comprises ashwagandha.

[0080] n an exemplary embodiment, the nutritional composition comprises cardamom,

[0081] n an exemplary embodiment, the nutritional composition comprises ginger,

[0082] n an exemplary embodiment, the nutritional composition comprises lecithin,

[0083] n an exemplary embodiment, the nutritional composition comprises basil,

[0084] n an exemplary embodiment, the nutritional composition comprises lactoferrin.

[0085] n an exemplary embodiment, the nutritional composition comprises coenzyme Qio.

[0086] n an exemplary embodiment, the nutritional composition comprises cinnamon,

[0087] n an exemplary embodiment, the nutritional composition comprises chondroitin sulphate

[0088] n an exemplary embodiment, the nutritional composition comprises echinacea,

[0089] n an exemplary embodiment, the nutritional composition comprises glucosamine,

[0090] n an exemplary embodiment, the nutritional composition comprises milk thistle,

[0091] n an exemplary embodiment, the nutritional composition comprises salacia. [0092] In an exemplary embodiment, the nutritional composition comprises caffeine.

[0093] In an exemplary embodiment, the nutritional composition comprises lipoic acid.

[0094] In an exemplary embodiment, the nutritional composition comprises collagen.

[0095] In an exemplary embodiment, the nutritional composition comprises saw palmetto berries extract.

[0096] In an exemplary embodiment, the nutritional composition comprises ribose.

[0097] In an exemplary embodiment, the nutritional composition comprises guarana.

[0098] In an exemplary embodiment, the nutritional composition comprises quercetin.

[0099] In an exemplary embodiment, the nutritional composition comprises yerba mate.

[00100] In an exemplary embodiment, the nutritional composition comprises a phospholipid.

[00101] In an exemplary embodiment, the nutritional composition comprises citicholine.

[00102] In an exemplary embodiment, the nutritional composition comprises citicoline.

[00103] In an exemplary embodiment, the nutritional composition comprises protein. In an exemplary embodiment, the protein is intact protein. In an exemplary embodiment, the protein is hydrolyzed protein. In an exemplary embodiment, the protein is a combination of intact protein and hydrolyzed protein. In an exemplary embodiment, the protein is selected from the group consisting of milk protein isolate, milk protein concentrate, sodium caseinate, calcium caseinate, whey protein concentrate, whey protein isolate, hydrolyzed whey protein, soybean protein, pea protein, rice protein, potato protein, quinoa protein, lentil protein, wheat protein, bean protein, spirulina protein, hemp seed protein, and combinations thereof.

[00104] In an exemplary embodiment, the nutritional composition is a powder, and wherein a serving size of the composition is from 1 g to 40 g. In an exemplary embodiment, the serving size of the composition is from 5 g to 12 g. [00105] In an exemplary embodiment, the nutritional composition is a liquid, and wherein a serving size of the composition is from 1 ml to 40 ml. In an exemplary embodiment, the serving size of the composition is from 2 ml to 15 ml.

DETAILED DESCRIPTION

[00106] Several illustrative embodiments will be described in detail with the understanding that the present disclosure merely exemplifies the general inventive concepts. While

embodiments encompassing the general inventive concepts may take various forms, the general inventive concepts are not intended to be limited to the specific embodiments described herein.

[00107] The term "nutritional composition" as used herein, unless otherwise specified, refers to nutritional liquids and nutritional powders (i.e., "powdered nutritional compositions"), the latter of which may be reconstituted to form a nutritional liquid, all of which are suitable for oral consumption by a human. Although not a requirement, such nutritional compositions will often comprise at least one protein.

[00108] The term "hot beverage" as used herein, unless otherwise specified, refers to a beverage that is served or consumed above room temperature or above 70 °F. A hot beverage is preferably served or consumed between a temperature of 90 °F to 212 °F, including a temperature between 125 °F to 185 °F.

[00109] The terms "fat" and "oil" as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials derived or processed from plants or animals. These terms also include synthetic lipid materials so long as such synthetic materials are suitable for oral administration to humans.

[00110] The terms "serving," "serving of the nutritional composition," or "serving of the powdered nutritional composition" as used herein, unless otherwise specified, are intended to be construed as any amount meant to be consumed by an individual in one sitting or within one hour or less. In certain embodiments, a serving of the powdered nutritional composition has a mass of at least about 1 g, or at least about 5 g, or at least about 10 g, or at least about 12 g, or up to about 15 g, or up to about 25 g of the powdered nutritional composition. In certain

embodiments, a serving of the powdered nutritional composition equals about 5 g of the powdered nutritional composition, which may be dispersed in, for example, 8 fl oz (i.e., 1 cup) of a hot beverage. In certain embodiments, 1 serving of the powdered nutritional composition equals about 8 g of the powdered nutritional composition, which may be dispersed in, for example, 8 fl oz (i.e., 1 cup) of a hot beverage.

[00111] The terms "powder," "reconstitutable," and "reconstitutable powder" as used herein, unless otherwise specified, each describe a physical form of a nutritional composition, or portion thereof, that is flowable or scoopable and can be reconstituted with water or another aqueous liquid prior to consumption.

[00112] The term "Vitamin A" as used herein, unless otherwise specified, includes retinol, retinal, β-carotene, alpha-carotene, gamma-carotene, β-cryptoxanthin and combinations thereof.

[00113] The term "Vitamin B" as used herein, unless otherwise specified, includes Vitamin B complex including Bl thiamine, B2 riboflavin, B3 niacin, B3 niacineamide, B5 pantothenic acid, B6 pyridoxine, B6 pyridoxamine, B6 pyridoxal, B7 biotin, B9 folic acid, B9 folinic acid, B12 cyanocobalamin, B12 hydroxycobalamin, B12 methylcobalamin, and combinations thereof.

[00114] The term "Vitamin C" as used herein, unless otherwise specified, includes ascorbic acid.

[00115] The term "Vitamin D" as used herein, unless otherwise specified, includes any one of cholecalciferol, ergocalciferol, and combinations thereof.

[00116] The term "Vitamin K" as used herein, unless otherwise specified, includes any one of phylloquinone, menoquinones, and combinations thereof.

[00117] The term "Vitamin E" as used herein, unless otherwise specified, includes any one of a group of eight compounds that include the four tocopherols (alpha-, beta-, gamma-, and delta- tocopherols), the corresponding tocotrienols, stereoisomers of the foregoing, and combinations thereof. The tocopherols are molecules with a chromanol ring and a phytyl tail that differ in the number and position of methyl groups on the ring structure. The corresponding tocotrienols also include the chromanol ring and phytyl tail, however, the phytyl tail of the tocotrienols have three points of unsaturation. In certain embodiments, "Vitamin E" refers to RRR-a-tocopherol, other stereoisomers of α-tocopherol (i.e., RRS-, RSR-, RSS-, SRR-, SSR-, SRS-, and SSS-a- tocopherol), and combinations thereof. In certain embodiments, "Vitamin E" refers to a synthetic form of Vitamin E, such as all-rac-a-tocopheryl acetate or dl-a-tocopherol. In certain embodiments, "Vitamin E" refers to a combination of natural Vitamin E (i.e., RRR-a- tocopherol) and synthetic Vitamin E.

[00118] The term "minerals" as used herein, unless otherwise specified, refers to any one of major minerals, trace or minor minerals, other minerals, and combinations thereof. Major minerals include calcium, phosphorus, potassium, sulfur, sodium, chlorine, magnesium. Trace or minor minerals include iron, cobalt, copper, zinc, molybdenum, iodine, selenium, manganese and other minerals include chromium, fluorine, boron, lithium, and strontium.

[00119] The term "dispersion" as used herein, unless otherwise specified, refers to a mixture in which particles of one substance are scattered throughout another substance. A dispersion can manifest as a suspension, a colloid, or a solution.

[00120] The term "readily dispersible" as used herein, unless otherwise specified, refers to a solid that is easily blended with a liquid or other viscous substance such that almost no agglomeration or settling occurs with normal agitation or mixing for one minute or less. For example, manual stirring with a spoon or similar device may be sufficient to create a dispersion. As another example, vigorous shaking may be sufficient to create a dispersion. "Readily dispersible" is broader in scope than "soluble" or "dissolvable." In certain embodiments, the powdered nutritional composition or components thereof are compounded with or without the use of an emulsifier. An exemplary emulsifier is lecithin.

[00121] The term "safe energy drink" as used herein, unless otherwise specified, refers to a beverage fortified with additives intended to enhance energy levels in the consumer, wherein the beverage is less likely to pose health risks from overconsumption (e.g., in caffeine na ^' ive or caffeine sensitive individuals) because of, for example, the temperature of the beverage, inherent properties of the beverage (e.g., its astringency), etc. The term "safe energy drink" can be used synonymously with the terms "enhanced energy drink" and "improved energy drink." [00122] As described herein the inventors have found an alternative nutrition delivery platform targeting coffee and tea consumers. A nutritional composition, i.e., a hot beverage fortifier (HBF) formulation, has been developed to provide nutrition by mixing with a hot beverage, including coffee and tea. Additionally, in some embodiments, the HBF formulation can be mixed with a hot beverage, including coffee and tea, to provide a safe energy drink.

[00123] Coffee and tea jointly represent the second most consumed beverage in the world after water with more than 1 trillion servings per year in certain markets. These hot beverages are typically poor sources of proteins and amino acids, as well as vitamins, minerals, nutrients, and other key ingredients. During the morning hours, for example, consumers generally replace nutritional beverages with either coffee or tea. Thus, the use of the nutritional compositions of the current disclosure can improve nutrient intake in the typical consumer's diet during these hours by providing a source of protein and/or amino acids, as well as vitamins, minerals, nutrients, and other key ingredients such as dietary fiber, green tea extract, β-glucan, β-hydroxy β-methylbutyrate (HMB), curcumin, turmeric root extract, docosahexanoic acid ("DHA"), and arachidonic acid ("ARA"). In some instances, the nutritional compositions of the current disclosure can be used to transform beverages such as coffee and tea into safe energy drinks.

Product Form

[00124] A powdered nutritional composition of the present disclosure can be 1 g to 25 g (including 5 g to 12 g) and can be packaged as a single serving stickpacks, as well as other packaging embodiments like small single serving plastic containers, creamer cups, or large bulk containers. The nutritional compositions may be formulated with sufficient amounts of nutrients to provide a sole, primary, or supplemental source of nutrition.

[00125] The powdered nutritional composition of the present disclosure may be formulated to provide a specialized nutritional composition for use in individuals afflicted with specific diseases or conditions. Additionally, the powdered nutritional composition may be formulated with targeted nutritional and/or health benefits, including increasing energy levels, improving or maintaining heart health, preventing heart disease, improving diabetic health, preventing diabetic syndrome, reducing blood sugar spikes, preserving muscle health, and improving muscle recovery and cognition. Different formulations of the nutritional compositions provide the required levels of certain ingredients for each nutritional and/or health benefit. For example, an embodiment for improving or preserving heart health may have the required amount of β-glucan or another active ingredient to make a cardiovascular health claim according to FDA guidelines.

[00126] The powdered nutritional composition is intended to be readily dispersed into any prepared coffee or tea drink by manual stirring with a spoon, regardless of the type, style and brand with or without adding milk, dairy creamer, or nondairy based creamer. For example, the powdered nutritional composition can be used with a dark coffee in the U.S., with cappuccino in Italy, with green/herbal tea in China, with a breakfast tea in the U.K. or with masala chai in India.

[00127] The powdered nutritional composition overcomes the drawbacks of existing creamers by allowing the users to nutritionally complement their hot beverages without affecting the type, color, style, regional recipe, or brand of coffee or tea. In certain embodiments, the powdered nutritional composition does not substantially lighten or alter a color of the beverage. In certain embodiments, the powdered nutritional composition does not substantially alter or reduce the astringency of the beverage.

[00128] Generally, ingredients which are sources of β-glucan or fiber increase the viscosity of a beverage and do not disperse well in products targeted for consumption at room or refrigerated temperatures. Thus, it is difficult to use higher quantities of β-glucan or fiber in a beverage consumed at room temperature or lower without affecting dispersibility and rheological properties like mouthfeel. Surprisingly, higher temperature beverages or hot beverages (e.g., between 149 °F to 185 °F) are very efficient in improving the viscosity and solubility of β- glucan, fiber, and other similar ingredients. This allows use of a higher percentage of these normally difficult to use ingredients in a beverage without adversely affecting dispersibility or palatability.

[00129] Coffee and tea are characterized by a predominant astringent or bitter taste, which is not usually preferred in food formulations. The powdered nutritional composition presents a unique opportunity to use astringent and bitter ingredients like hydrolyzed proteins, certain amino acids, green tea extract, and various other botanical extracts which may enhance the sensory affect of the beverage or at least not detract from it. The ability of the powdered nutritional composition to not detract from the sensory affect of the beverage is also one of the main differentiating factors that separates it from a traditional non-dairy creamer.

Nutritional Powders

[00130] The powdered nutritional composition may be dispersed in a suitable aqueous liquid, semi-liquid, or semi-solid, for example, a beverage like coffee, tea, or other aqueous liquid, prior to consumption in an amount or volume sufficient to form a fortified hot beverage for oral or enteral use. The powdered nutritional composition may include spray dried powders, dry mixed powders, dryblended powders, agglomerated powders, lecithinated powders, combinations thereof, or powders prepared by other suitable methods. The powdered nutritional composition may be blended by any dry blending method known in the art, including but not limited to blending using a ribbon blender or a plow blender.

[00131] The powdered nutritional composition is designed to form a dispersion when mixed with a hot beverage, such as coffee or tea. Thus, powdered nutritional composition of the present disclosure is readily dispersible in such hot beverages. The powdered nutritional composition may be mixed with a beverage having a temperature of 90 °F to 212 °F without forming aggregates and without settling out of the dispersion. The powdered nutritional composition may be mixed with a beverage having a temperature of 125 °F to 185 °F without forming aggregates and without settling out of the dispersion. By way of example, the powdered nutritional composition may be mixed with a beverage with manual stirring, such as by mixing using a spoon, for approximately one minute.

Protein

[00132] In certain embodiments, the powdered nutritional composition comprises at least one source of protein in an amount sufficient to provide from about 1 g to about 25 g of protein per serving of the powdered nutritional composition. In certain embodiments, the powdered nutritional composition comprises from about 3 g to about 4 g of protein per serving, including from about 1 g to about 20 g of protein, including from about 1 g to about 15 g of protein, including from about 1 g to about 10 g of protein, including from about 5 g to about 8 g of protein, and also including from about 8 g to about 10 g of protein per serving. In certain other embodiments, the at least one source of protein comprises about 1% to about 95% of the powdered nutritional composition, by weight, including from about 30% to about 60%, and also including about 30%> to about 45% by weight of the composition. Virtually any source of protein may be used so long as it is suitable for use in oral nutritional compositions and is otherwise compatible with any other selected ingredients or features in the powdered nutritional composition.

[00133] The source of protein may include, but is not limited to, intact, hydrolyzed, and partially hydrolyzed protein, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy, potato, pea), and combinations thereof. Non-limiting examples of the source of protein include whey protein concentrates, whey protein isolates, whey protein hydrolysates, acid caseins, sodium casemates, calcium casemates, potassium casemates, casein hydrolysates, milk protein concentrates, milk protein isolates, milk protein hydrolysates, nonfat dry milk, condensed skim milk, soy protein concentrates, soy protein isolates, soy protein hydrolysates, pea protein concentrates, pea protein isolates, pea protein hydrolysates, collagen proteins, insect proteins, earthworm proteins, and combinations thereof. In addition, the at least one source of protein in an amount sufficient to provide 1 g to 25 g of protein per serving may comprise any one source of protein or any combination of any of the various sources of protein provided in the non- limiting list presented above.

Carbohydrate

[00134] In certain embodiments, the powdered nutritional composition may comprise any carbohydrates or sources thereof that are suitable for use in an oral nutritional composition and are compatible with the elements and features of such compositions. When present in the powdered nutritional compositions, carbohydrate concentrations may range, for example, from about 0.1%) to about 70%> by weight of the composition. When present in the powdered nutritional composition, carbohydrate concentrations may be at least about 0.1%, or at least about 1%, or at least about 5%, or at least about 8%, or at least about 10%, or at least about 12%, or at least about 15%, or at least about 18%, or at least about 20%>, and up to about 25%, or up to about 30%), or up to about 40%, or up to about 50%, or up to about 70%, by weight of the powdered nutritional composition. [00135] Non-limiting examples of suitable carbohydrates or sources thereof for use in the powdered nutritional composition described herein include maltodextrin (e.g. , maltodextrin having a dextrose equivalent ("DE") number ranging from 4 to 20), corn maltodextrin, sucromalt, maltitol powder, glycerine, glucose polymers, corn syrup, corn syrup solids (e.g., corn syrup solids having a DE number of at least 21), modified starches, resistant starches, 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), artificial sweeteners (e.g. , sucralose, acesulfame potassium, stevia, alitame, aspartame, sodium cyclamate, dulcin, glucin, neotame, saccharin), fructooligosaccharides, soy fiber, corn fiber, guar gum, konjac flour, poly dextrose, Fibersol, and combinations thereof.

[00136] In certain embodiments, the powdered nutritional composition comprises from about 1% to about 50% by weight fructooligosaccharides. In certain embodiments, the powdered nutritional composition comprises at least about 1%, or at least about 5%, or at least about 10%, or at least about 15%, and up to about 25%, or up to about 30%, or up to about 40%, or up to about 50%) by weight fructooligosaccharides.

Fat

[00137] In certain embodiments, the powdered nutritional composition may contain oil.

However, the powdered nutritional composition typically is not oil based. Oil is not a major component of the powdered nutritional composition as it is in a typical creamer. The powdered nutritional composition typically does not comprise more than about 40% oil by weight of the total composition. In some exemplary embodiments the powdered nutritional composition contains little or no oil, including less than 30% oil by weight of the total composition, including less than 25% oil, including less than 10% oil, including less than 5% oil, including less than 1% oil. Thus, the composition is different from a typical creamer in that it is not oil based or does not contain oil as a major ingredient.

[00138] More generally, the powdered nutritional composition may comprise fat or a source thereof, most typically as emulsified fat, concentrations of which may range from about 0.1% to about 40% by weight of the powdered nutritional composition. The powdered nutritional composition may comprise fat or a source thereof, which may be emulsified fat, at a concentration of at least about 0.1%, or at least about 0.5%, or at least about 1%, or at least about 2%o, or at least about 4%, and up to about 5%, or up to about 10%>, or up to about 15%, or up to about 20%), or up to about 25%, or up to about 30%, or up to about 40%, by weight of the powdered nutritional composition. In some embodiments, the fat concentration may be from about 0.5%) to about 4.0%, from about 0.5% to about 3.0%>, from about 0.5% to about 2.0%>, from about 0.5%) to about 1.5%, from about 0.5% to about 1.0%, from about 0.75% to about 1.0%, from about 0.8% to about 1.0%, or from about 0.85% to about 0.95% by weight of the powdered nutritional composition. In some embodiments, the fat is present in an amount of about 0.9% by weight of the powdered nutritional composition.

[00139] Suitable sources of fat for use herein include any fat or fat source that is suitable for use in an oral nutritional composition and is compatible with the elements and features of such products. Preferably, but not necessarily, a fat source will provide at least one long chain polyunsaturated acid ("LC-PUFA") such as docosahexanoic acid ("DHA"), arachidonic acid ("ARA"), conjugated linoleic acid ("CLA"), gamma linoleic acid ("GLA"), and/or

eicosapentaenoic acid ("EPA"). These LC-PUFAs may be optionally added to the powdered nutritional composition outside of, or in addition to, a fat source.

[00140] Non-limiting examples of suitable fats or sources thereof for use in the powdered nutritional composition include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, medium chain triglycerides ("MCT oil"), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, borage oil, fish oil, structured lipids, rice bran oil, and combinations thereof.

[00141] Other non-limiting examples of suitable fats or sources thereof for use in the powdered nutritional composition include a marine oil, a plant oil, and an animal oil. Suitable marine oils include, without limitation, dietary source of omega-3, omega-6, EPA and DHA from oily fish including salmon, herring, mackerel, anchovies, sardines, tuna, swordfish, cod, and krill.

Suitable sources of the plant oil include, without limitation, coconut, corn, cottonseed, olive, palm, peanut, rapeseed, safflower, sesame, soybean, sunflower, mustard, almond, beech nut, cashew, borage seed, flaxseed, krill, and combinations thereof. Suitable sources of the animal oil include, without limitation, butter, lard, butter oil, and combinations thereof. Beta-Hvdroxy-Beta-Methylbutyrate (HMB)

[00142] In some embodiments, the powdered nutritional composition comprises HMB. In some embodiments the HMB is calcium HMB (e.g., as a monohydrate). Thus, the powdered nutritional composition is either formulated with the addition of calcium HMB or are otherwise prepared so as to contain HMB in the finished composition. Any source of HMB is suitable for use herein provided that the finished product contains HMB, which is most typically added as calcium HMB to the powdered nutritional composition during formulation.

[00143] Although calcium HMB monohydrate is a preferred source of HMB for use in the powdered nutritional composition, other suitable sources may include HMB as the free acid, a salt, an anhydrous salt, an ester, a lactone, or other product form that otherwise provides a bioavailable form of HMB from the powdered nutritional composition. Non- limiting examples of suitable salts of HMB for use herein include HMB salts, hydrated or anhydrous, of sodium, potassium, magnesium, chromium, calcium, or other non-toxic salt forms. Calcium HMB monohydrate is one preferred source and is commercially available from Technical Sourcing International (TSI) of Salt Lake City, Utah.

[00144] The concentration of HMB in the powdered nutritional composition may range up to about 30%, including from about 0.01% to about 10%>, including from about 0.01% to about 15%), and also including from about 0.01% to about 20%>, and also including from about 0.01% to about 25%), and also including from about 0.01% to about 30%>, by weight of the powdered nutritional composition. In some specific embodiments, the powdered nutritional composition include about 16% HMB or about 30%, HMB by weight of the nutritional composition.

[00145] The powdered nutritional composition of the present disclosure desirably includes sufficient HMB to provide an individual with from about 0.1 g to about 10 g, including from about 0.5 g to about 10 g, including from about 1 g to about 8 g, including from about 2 g to about 7 g, and also including from about 3 g to about 6 g, per day of HMB. In one embodiment, the daily intake of HMB by the individual is about 1.5 g. The total daily HMB may be contained in one, two, three, or more servings of the powdered nutritional composition. Beta-Alanine

[00146] In some embodiments, the powdered nutritional composition comprises β-alanine. Generally, the powdered nutritional composition will include β-alanine in concentrations ranging from about 1% to about 60%, including from about 1% to about 50%>, including from about 0.1 % to about 3%) by weight, including from about 0.1% to about 2% by weight, including from about 0.1%) to about 1%) by weight, including from about 0.25% to about 0.50% by weight, including from about 0.26% to about 0.47% by weight.

[00147] The powdered nutritional composition may be formulated with the addition of β- alanine, or may otherwise be prepared so as to contain β-alanine in the finished composition. Any source of β-alanine may be suitable for use in the composition provided that the finished composition contains β-alanine at the desired level. Such sources may be and typically do include free β-alanine as well as other sources that provide free β-alanine in the powdered nutritional composition during or after formulation.

Functional Amino Acids and Branched Chain Amino Acids

[00148] In some embodiments, the powdered nutritional composition comprises one or more functional amino acids and/or one or more branched chain amino acids. The term "functional amino acid" as used herein refers to an amino acid that can regulate key metabolic pathways to improve health, growth, development and reproduction of animals and humans. This metabolic regulation involves cell signaling through the functional amino acids and their metabolites. The metabolic pathways may include protein synthesis, hormone secretion (and, in particular, GLP-1 and insulin secretion), antioxidative reactions, and oxidation of energy substrates. A functional amino acid can be either a "nonessential" or an "essential" amino acid. The functional amino acid may also further promote muscle glycogen synthesis, reduce fat mass, and/or enhance insulin sensitivity. These benefits further provide dietary management of, and thus, delay the progression of type 2 diabetes.

[00149] Amino acids for use in the powdered nutritional composition include one or more of tyrosine, phenylalanine, taurine, valine, leucine, isoleucine, alanine, arginine, glutamine, lysine, aspartic acid, glutamic acid, proline, cysteine, ornithine, selenocysteine, threonine, methionine, histidine, tryptophan, asparagine, glycine, serine, and combinations thereof. [00150] The functional amino acids and branched chain amino acids used may be in the form of free amino acids, salt form (e.g., L-arginine hydrochloride), peptide-bound form (e.g., L- alanyl-L-glutamine), and protein-bound form (e.g., bovine β-lactoglobulin). Although all of these forms are suitable and within the scope of the present disclosure, the free form functional amino acids and free form branched chain amino acids are particularly suitable as these forms are the most concentrated and their addition rate into the powdered nutritional composition can be easily controlled.

[00151] In some embodiments, the powdered nutritional composition includes a combination of functional amino acids and/or a combination of functional amino acids and branched chain amino acids such that the composition provides sufficient functional amino acids to provide increased insulin secretion to reduce postprandial blood glucose levels and manage type 2 diabetes. For example, in one embodiment, the powdered nutritional composition includes a combination of arginine, glutamine, and leucine to increase secretion of insulin.

[00152] The powdered nutritional composition may include the one or more functional amino acids and/or branched chain amino acids in total amounts of from about 1% to about 40% by weight, including from about 10%> to about 35% by weight, including from about 15% to about 30%) by weight, and including from about 20%> to about 25% by weight. In other embodiments, the powdered nutritional composition may include the functional amino acid and/or branched chain amino acid in an amount of from about 0.1% to about 10% by weight, including from about 1%) to about 10%> by weight, including from about 1% to about 5% by weight, and including from about 1% to about 3% by weight.

Carotenoids

[00153] In certain embodiments, the powdered nutritional composition comprises one or more carotenoids. Some desirable carotenoids include lutein, lycopene, alpha-carotene, β-carotene, zeaxanthin, and cryptoxanthin. In certain instances lutein is particularly desirable.

[00154] The term "lutein" as used herein, unless otherwise specified, refers to one or more of free lutein, lutein esters, lutein salts, or other lutein derivatives or related structures as described or otherwise suggested herein. Lutein or lutein sources suitable for use in the powdered nutritional composition of the present disclosure include free lutein as well as esters, salts, or other derivatives or related structures thereof, including those that conform to the formula:

[00155] The above formula includes the general structure of lutein and related derivatives or structures. Free lutein, for example, corresponds to the formula wherein Ri and R ₂ are both hydrogen, and includes cis and trans isomers thereof as well as salts thereof {e.g. , sodium and potassium salts).

[00156] Lutein esters suitable for use herein include any lutein ester of the above formula wherein Ri and R ₂ are the same or different, and are nutritionally acceptable monovalent salts, hydrogen, or an acyl residue of a carboxylic acid. Suitable lutein esters include, as well, both cis and trans isomers, with trans isomers being preferred {i.e., trans-lute ). The Ri and R ₂ moieties are residues of a saturated or unsaturated Ci to C ₂₂ fatty carboxylic acid, non-limiting examples of which include formic, acetic, propionic, butyric, valeric, caproic, caprylic, capric, lauric, myristic, palmitic, stearic, and oleic acids.

[00157] Lutein for use herein includes any natural or synthetic source that is known for or is otherwise an acceptable source for use in oral nutritional compositions. Lutein sources can be provided as individual ingredients or in any combination with other materials or sources, including sources such as multivitamin premixes, mixed carotenoid premixes, pure lutein sources, and inherent lutein from other fat or oil components in the powdered nutritional composition. The lutein concentrations and ratios as described herein are calculated based upon added and inherent lutein sources. In some embodiments, the powdered nutritional composition comprises at least 25%, and preferably from about 50%> to about 95%, by weight of total lutein as added lutein, the remainder being inherent lutein that accompanies added fats and oils.

[00158] In some embodiments, the powdered nutritional composition comprises at least one of lutein, lycopene, zeaxanthin, and β-carotene to provide a total amount of carotenoid of from about 0.1 μg to about 5 mg per about 16 g of powdered nutritional composition. In some embodiments, the powdered nutritional composition comprises lutein in an amount of from about 0.1 μ to about 5 mg, per about 16 g of powdered nutritional composition.

[00159] In some embodiments, the powdered nutritional composition comprises lycopene in an amount of from about 0.2 μg to about 3 mg. In some embodiments, the powdered nutritional composition comprises lycopene in an amount of at least 0.2 μg, at least 2 μg, at least 4 μg, or at least 1 mg, up to about 2 mg, or up to about 3 mg, per about 16 g of powdered nutritional composition. In some embodiments, the powdered nutritional composition comprises from about 2 μg to about 3 mg, from about 2 μg to about 400 μg, from about 0.9 mg to about 1.5 mg, from about 0.2 μg to about 1.2 mg, from about 0.2 μg to about 3.1 μg, from about 0.2 μg to about 1.8 μg, or from about 4.3 μg to about 1.2 mg, all per about 16 g of powdered nutritional composition.

[00160] In some embodiments, the powdered nutritional composition comprises zeaxathin in an amount of from about 0.2 μg to about 3 mg, per about 16 g of powdered nutritional composition. In some embodiments, the powdered nutritional composition comprises zeaxanthin in an amount of at least about 0.2 μg, and up to about 500 μg, or up to about 1 mg, or up to about 2 mg, or up to about 3 mg, all per about 16 g of powdered nutritional composition.

[00161] In some embodiments, the powdered nutritional composition comprises β-carotene in an amount of from about 0.1 μg to about 3 mg, per about 16 g of powdered nutritional composition. In some embodiments, the powdered nutritional composition comprises at least about 0.1 μg, or at least about 1 μg, or at least about 10 μg, or at least about 100 μg, or at least about 200 μg, and up to about 1 mg, or up to about 2 mg, or up to about 3 mg, per about 16 g of powdered nutritional composition.

[00162] It should be understood that any combination of these amounts of lutein, lycopene, zeaxanthin, and β-carotene can be included in the powdered nutritional composition. Optionally, other carotenoids may be included in the powdered nutritional composition. The carotenoids included in the powdered nutritional composition may be from a natural source or artificially synthesized. [00163] Non-limiting examples of lutein sources which may be suitable for use herein include FloraGLO® Crystalline Lutein, available from Kemin Foods, Des Moines, Iowa, USA; and Xangold ® Lutein Esters provided by Cognis, Cincinnati, Ohio, USA.

Catechins and Epicatechin Gallate (EGCG)

[00164] The powdered nutritional composition may include one or more catechins. As used herein, "catechin" is meant to refer to flavonoid phytochemical compounds that appear predominantly in green tea and, to a lesser extent, in black tea, grapes, wine, and chocolate. Examples of catechins that can be used in the practice of the present disclosure include gallocatechin ("GC"), epigallocatechin ("EGC"), epicatechin ("EC"), epicatechin gallate

("ECG"), and epigallocatechin gallate ("EGCG"), as well as mixtures of these and other catechins. The catechins used in the powdered nutritional composition can be prepared from lipid extracts from green tea leaves. The catechins can be purified to any suitable level, such as about 50%, about 60%, about 70%, about 80%, about 85%, about 90%, and/or about 95%. One example of a suitable catechin is an extract (e.g., an 80% catechin extract) of Camellia sinensis.

[00165] Generally, the catechins may be present in the powdered nutritional composition in an amount of from about 0.1% to about 10%, including from about 0.1% to about 2%, including from about 1% to about 6%, and including from about 3% to about 6%> by weight of the powdered nutritional composition.

Curcumin and Bioavailable Curcumin

[00166] In some embodiments the powdered nutritional composition may include curcumin, including bioavailable curcumin. Curcumin, 1 ,7-bis (4-hydroxyphenyl)-l,6-heptadiene-3,5- dione, has the chemical structure:

[00167] Curcumin is the principal curcuminoid of turmeric. Conventionally, some curcumin products have lower bioavailability when taken orally, and thus are formulated at higher concentrations to counter the inherent poor bioavailability of the curcumin and to achieve the desired systemic delivery. As a result, products containing curcumin often take on an intense undesirable yellow color. In some embodiments, the powdered nutritional composition uses bioavailable curcumin, which has an improved bioavailability as compared to conventional curcumin. As such, the bioavailable curcumin can be utilized in lower concentrations in the powdered nutritional composition and methods of the present disclosure, while still maintaining its anti-inflammatory, antioxidative, and anti-amyloidogenic activity.

[00168] The term "bioavailable curcumin" refers to curcumin and derivatives and analogs thereof, including natural and synthetic derivatives of curcumin, as well as any combination of one or more of curcumin and a derivative and/or analog. In particular, the term "bioavailable curcumin" should be understood to encompass compounds having a 1,7-bis (4-hydroxyphenyl)- l,6-heptadiene-3,5-dione or l,7-bis(4-hydroxyphenyl) hept-4-en-3-one skeleton wherein the phenyl groups independently may bear one or more alkoxy residues, especially one methoxy residue in the 3-position. In some embodiments, additional curcuminoids, such as

demethoxycurcumin and bisdemethoxycurcumin, may also be present in the powdered nutritional composition. When present, demethoxycurcumin and bisdemethoxycurcumin may be present as part of a complex with curcumin.

[00169] The "bioavailable curcumin" used in the powdered nutritional composition shows improved oral bioavailability as compared to curcumins that are not substantially "bioavailable." The oral bioavailability can be determined in experiments involving oral administration of the bioavailable curcumin composition of the present disclosure (and/or a corresponding amount of non-bioavailable curcumin) to a subject and measuring the level of the curcumin in a biological sample obtained from the subject over time, wherein the biological sample may be derived from a body fluid, for example, serum, plasma, whole blood, or cerebrospinal fluid, and/or a tissue, for example, brain, liver, kidney, or heart. For analysis, the curcumin level in the examined body fluid or tissue may be plotted against time, and the area under the curve (AUC), for example the total area under the curve from t = 0 (time of administration) to t = infinity (= AUCO-infinity), or the area under the curve within a defined period, e.g. from t = 0 to t = 6 hours (AUC0-6H), may be calculated. In general, a higher AUC relative to the AUC obtained by administration of non- bioavailable curcumin indicates an improved bioavailability. The absolute bioavailability may be calculated from the resulting AUC data as a percentage based on the corresponding AUC data obtained from intravenous administration of curcumin.

[00170] In some embodiments, the bioavailable curcumin amount in the blood, determined as AUC0-6H after a single oral administration of a dose of the bioavailable curcumin-containing nutritional composition of the present disclosure corresponding to 20 mg of total curcumin to a human subject or an animal subject, e.g., a rat, is significantly higher than after oral

administration of the same amount of non-bioavailable curcumin in the composition, preferably at least 2 times, at least 3 times, at least 4 times, at least 6 times, at least 8 times, at least 10 times, or at least 15 times, and, for example, up to 30 times higher.

[00171] As used herein, the amount of curcumin in the blood being "significantly higher" means a statistically significant increase of this parameter in subjects after oral administration of 20 mg of bioavailable curcumin in the powdered nutritional composition as compared to a control 20 mg of curcumin that is not bioavailable. A statistical test known in the art, such as ANOVA or Student's t-test, may be used to determine the significance of this difference, wherein the p-value is at least <0.1, <0.5, <0.01, <0.005, <0.001 or <0.0001.

[00172] Bioavailable curcumin can be prepared in a number of ways including, for example, using Meltrex® or similar melt-extrusion technology to prepare extruded solids and improve the bioavailability of the curcumin as compared to curcumin not produced by melt extrusion.

Meltrex® or similar melt-extrusion technology methods are known in the art and can be applied to produce bioavailable curcumin by one skilled in the art based on the disclosure herein.

[00173] In another embodiment, curcumin or bioavailable curcumin can be co-supplemented with piperine (generally extracted from black pepper) to increase the bioavailability and hence the absorbability of curcumin. In one embodiment, the piperine is co-supplemented in an amount of about 20 mg to increase the bioavailability of the curcumin.

[00174] In another embodiment, the curcumin or bioavailable curcumin may be solubilized in an oil having an hydrophilic-lipophilic balance (HLB) of from about 0.7 to about 14 (polar oils) such that the resulting oil mixture provides increased bioavailability of curcumin. One suitable polar oil for dissolving the curcumin is a medium chain triglyceride (MCT) oil. [00175] In one embodiment, the bioavailable curcumin is a mixture of curcuminoids (i.e., curcumin, demethoxycurcumin and bisdemethoxycurcumin) obtained from the rhizomes of curcuma longa. In another embodiment, the bioavailable curcumin is obtained using Meltrex® technology (Abbott Nutrition, Columbus, Ohio). In yet another embodiment, the bioavailable curcumin is Meriva bioavailable curcumin, commercially available from Idena SPA (Milan, Italy).

[00176] The curcumin or bioavailable curcumin concentration in the powdered nutritional composition may range from at least about 0.001%, including from about 0.002% to about 3.36%), including from about 0.005%) to about 1.87%, also including from about 0.03%> to about 0.935%), also including from about 0.1 % to about 0.467%), and also including from about 0.234%> to about 0.3%, by weight of the powdered nutritional composition. Exemplary embodiments of the present disclosure include nutritional compositions having curcumin or bioavailable curcumin in amounts ranging from about 0.002% to about 0.25%, including from about 0.002% to about 0.234%, from about 0.005% to about 0.467%, from about 0.03% to about 0.935%, from about 0.1%) to about 1.9%, from about 0.1%> to about 1.87%, and from about 0.3% to about 3.36%), by weight of the powdered nutritional composition.

[00177] When utilized, the powdered nutritional composition of the present disclosure desirably includes sufficient curcumin or bioavailable curcumin to provide an individual with at least 1 mg, including at least 3 mg, including from about 10 mg to about 10,000 mg, including from about 100 mg to about 4,000 mg, including from about 400 mg to about 2,000 mg, including from about 1,200 mg to about 1 ,800 mg, per day of curcumin or bioavailable curcumin. The total daily amount of curcumin or bioavailable curcumin may be administered to an individual in a single undivided dose, or may be split into one, two, three, four, or more doses per day.

Vitamin E / Tocopherol

[00178] Vitamin E is an essential, lipid-soluble compound that exhibits antioxidant activity. As previously mentioned, the term "Vitamin E" refers to a group of eight compounds that include the four tocopherols (alpha-, β-, gamma-, and delta-tocopherols), the corresponding tocotrienols, stereoisomers of the foregoing, salts thereof, derivatives thereof, and combinations thereof. The alpha-tocopherols exhibit the most biological activity and accumulation in mammalian tissues. Common natural sources of Vitamin E (e.g., R R-a-tocopherol, d-a- tocopherol) include vegetable oils, green leafy vegetables, and nuts. There is considerable evidence to support differential bioavailability and bioactivity between natural and synthetic forms of Vitamin E. The synthetic form of Vitamin E (e.g., all-rac-a-tocopherol acetate, dl-a- tocopherol) is the form of Vitamin E that is most often included in Vitamin E supplements and used in the dietary fortification of foods.

[00179] Studies have indicated that Vitamin E supplementation promotes bioactivity that is specific to muscle tissue. Accordingly, increasing Vitamin E levels in muscle tissue can promote improvements in body composition and muscle function by reducing oxidative stress that would otherwise promote muscle atrophy, inhibiting muscle protein degradation, promoting muscle membrane integrity and repair, and combinations thereof.

[00180] In some embodiments, the powdered nutritional composition comprises total combined tocopherols in an amount of from about 0.5 mg to about 15 mg, per about 5 g to 10 g serving of powdered nutritional composition. In some embodiments, the powdered nutritional composition comprises total combined tocopherols in an amount of at least about 0.5 mg, or at least about 1 mg, or at least about 2 mg, or at least about 3 mg, or at least about 4 mg, or at least about 5 mg, and up to about 7 mg, or up to about 8 mg, or up to about 9 mg, or up to about 10 mg, or up to about 12 mg, or up to about 15 mg, per about 5 g to about 10 g serving of powdered nutritional composition.

Reconstitutable Milk

[00181] In some embodiments the powdered nutritional composition comprises reconstitutable milk. When comprising reconstitutable milk, the powdered nutritional composition typically only requires the addition of an appropriate amount of a hot beverage like coffee or tea, thereby generating the final consumable liquid nutritional composition or fortified hot beverage. The reconstitutable milk may be present in the powdered nutritional composition in an amount ranging from about 400 mg to about 900 mg per 1 g of powdered nutritional composition. The reconstitutable milk may be present in the powdered nutritional composition in an amount of at least about 400 mg, or about 500 mg, and up to about 700 mg, or up to about 900 mg, per 1 g of powdered nutritional composition.

Other Additives

[00182] The powdered nutritional composition may further comprise other therapeutic ingredients. Many such therapeutic ingredients are known to be suitable for use in other powdered nutritional compositions and may also be used in the powdered nutritional

composition described herein, provided that such optional ingredients are safe and effective for oral administration and are compatible with the other ingredients in the selected product form. Therapeutic ingredients may include without limitation mulberry leaf extract, ginseng, resveratrol, acai, a probiotic, grape seed extract, gingko biloba, ashwagandha, cardamom, ginger, lecithin, basil, lactoferrin, coenzyme Q10, cinnamon, chondroitin sulphate, echinacea, glucosamine, milk thistle, salacia, caffeine, lipoic acid, collagen, a phytosterol, saw palmetto berries extract, ribose, guarana, quercetin, yerba mate, and combinations thereof.

Other Optional Ingredients

[00183] The powdered nutritional composition may further comprise other optional ingredients that modify the physical, chemical, functional, hedonic, and/or processing characteristics of the products or serve as pharmaceutical or additional nutritional components when used in the targeted population. Many such optional ingredients are known to be suitable for use in other powdered nutritional compositions and may also be used in the powdered nutritional

composition described herein, provided that such optional ingredients are safe and effective for oral administration and are compatible with the other ingredients in the selected product form.

[00184] Non-limiting examples of such optional ingredients include preservatives,

antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients as described herein, colorants, flavors, thickeners (e.g. , induced viscosity fibers), additional stabilizers, cereal β-glucans (barley β-glucan), probiotics (e.g., Lactobacillus rhamnosus HNOOl (DR20)), prebiotics (fructooligosaccharides, galactooligosaccharides, inulin, oligofructose), Salacia extract, citicholine, citicoline, nicotinamide riboside, and so forth.

[00185] A flowing agent or anti-caking agent may be included in some embodiments of the powdered nutritional composition, or with any ingredient thereof disclosed herein, to retard clumping or caking of the powdered composition over time and to make the powdered composition flow easily from its container. Any known flowing or anti-caking agents that are suitable for use in other nutritional powders or similar product forms are suitable for use herein, non-limiting examples of which include tricalcium phosphate, silicates, and combinations thereof. The concentration of the flowing agent or anti-caking agent in certain embodiments of the powdered nutritional composition varies depending upon the product form, the other selected ingredients, the desired flow properties, and so forth, but most typically range from about 0.1% to about 4% or from about 0.5% to about 2% by weight of the powdered nutritional composition.

[00186] In some embodiments, the powdered nutritional composition comprises a flavoring agent. For example, the powdered nutritional composition can comprise up to 2% by weight of a flavoring agent. Suitable flavoring agents for use with the exemplary embodiments of the powdered nutritional composition include, for example, vanilla, cocoa, vanillin, salt, coffee, chocolate, berry flavors, and fruit flavors, acids (lactic, malic, etc.), caramel, mint, natural and/or artificial sweeteners, sodium sources such as sodium chloride, hydrocolloids, and combinations thereof.

[00187] In some embodiments, the powdered nutritional composition comprises a stabilizer. Any stabilizer that is known or otherwise suitable for use in a powdered nutritional composition may also be suitable for use herein, some non-limiting examples of which include gums such as xanthan gum. In certain embodiments, the stabilizer may represent from about 0.1% to about 5% by weight of the powdered nutritional composition. In certain embodiments, the stabilizer may represent at least about 0.1 %, or at least about 0.5%>, or at least about 0.7%>, and up to about 1.5%, or up to about 3%, or up to about 5%, by weight of the powdered nutritional composition.

[00188] In some embodiments, the powdered nutritional composition includes one or more masking agents to reduce or otherwise obscure the development of any residual bitter flavors and after taste developing the powdered nutritional composition over time. Suitable masking agents include natural and artificial sweeteners; sodium sources such as sodium chloride; hydrocolloids such as guar gum, xanthan gum, carrageenan, gellan gum, other suitable gums; emulsifiers; encapsulating agents such as starches and modified starch products; and combinations thereof. The amount of masking agent in certain embodiments of the powdered nutritional composition may vary depending upon the particular masking agent selected, other ingredients in the formulation, and other formulation or product target variables. Such amounts, however, most typically range from about 0.001% to about 25% by weight of the powdered nutritional composition. In some embodiments, the masking agent may be present in the powdered nutritional composition at a concentration of at least about 0.001%, at least about 0.01%, at least about 0.1%), up to about 2%, up to about 5%, up to about 10%>, or up to about 25%, by weight of the powdered nutritional composition.

[00189] In some embodiments, the powdered nutritional composition may include fish oil masking agents to mask "fishy" type flavors/aroma notes that commonly occur with the presence of fish/marine oil. For example, in some embodiments, the powdered nutritional composition may include lipid-amylose complex. Specifically, the combination of monoglycerides and low DE glucose polymers, such as DE-1 maltodextrin, form a lipid-amylose complex that can bind to oxidation products such as the fatty acid chain of aldehydes or ketones formed during oxidation of marine oils.

Methods of Manufacture

[00190] The powdered nutritional composition for use herein may be manufactured by any known or otherwise suitable method for making powdered nutritional compositions. The ingredients of the powdered nutritional composition can be blended by, for example, a ribbon blender, a plow blender, or any other known apparatus or system used for blending dry powdered ingredients. Alternately or in combination, the ingredients of the powdered nutritional composition can be spray dried using suitable spray drying techniques and conditions. When utilized, the spray drying may be "normal" (i.e., heated) spray drying or "cold" (i.e., unheated or cooled) spray drying. Regardless of the method utilized, in some embodiments, the powdered nutritional composition may be spray lecithinated or agglomerated. In some embodiments, the powdered nutritional composition may be extruded using one or more suitable single screw or multiple screw extruders. Such methods are well known in the nutrition formulation and manufacturing arts. Methods of Use

[00191] The powdered nutritional composition described herein will often comprise a protein, an additive, and may be blended with one or more additional ingredients. In some instances, the powdered nutritional composition comprises a protein and a plurality of additives selected from the group consisting of green tea extract, β-glucan, mulberry leaf extract, β-hydroxy β- methylbutyrate (HMB), a free amino acid, and combinations thereof. The powdered nutritional composition is blended with a beverage thereby generating the final consumable liquid nutritional composition or fortified hot beverage. In some instances, the beverage is hot (i.e., at a temperature of 90 °F to 212 °F). The blending of the powdered nutritional composition and a hot beverage can be carried out by manually stirring the ingredients together in an appropriate container using a simple kitchen utensil such as a spoon.

[00192] The final consumable liquid nutritional composition or fortified hot beverage is then consumed by a subject, typically a human being. To realize the benefits provided by the powdered nutritional composition, the powdered nutritional composition may be utilized on a daily or semi-daily basis for a time period of at least one week, at least two weeks, at least three weeks, at least one month, at least two months, at least three months, at least six months, or at least one year, as well as any effective length of time.

EXAMPLES

[00193] The following examples illustrate exemplary embodiments and features of the powdered nutritional composition of the present disclosure. The examples are given solely for the purpose of illustration and are not to be construed as limiting the present disclosure, as many variations thereof are possible and encompassed by the general inventive concepts.

[00194] The exemplified powdered nutritional composition may be prepared in accordance with manufacturing methods well known in the nutrition industry for preparing powdered nutritional compositions. For example, a powdered nutritional composition is made by dry- blending all of the following powdered ingredients in a ribbon or plow blender. The amount of powdered nutritional composition can be as little as, for example, 10 g to as much as 50 g per 8 fl oz of coffee or tea (237 ml or 250 g, or other serving amount of any fluid dairy product). Table 1 details a rough bill of materials for exemplary embodiments of the powdered nutritional composition, i.e., HBF formulations.

Table 1: Exemplary embodiments of the powdered nutritional composition.

Energy Drinks

[00195] In addition to the hot beverage fortifier (HBF) formulations described above, alternative HBF formulations are disclosed for transforming a beverage, such as coffee or tea, into an energy drink and, in particular, a safe energy drink.

[00196] Traditional energy drinks rely on added caffeine and other stimulants {e.g., taurine) to provide increased energy levels, or at least a sensation thereof. These conventional energy drinks are subject to abuse, misuse, or the like which can lead to unsafe conditions and/or outcomes.

[00197] For example, the product form of conventional energy drinks makes them an attractive option for combining with alcohol. Use of energy drinks reduces the feeling of inebriation, which can result in prolonged drinking sessions and increased consumption of alcohol. Studies have also shown that energy drinks may increase the risk of alcohol dependence. [00198] As another example, the product form of conventional energy drinks makes them readily suitable for rapid consumption and overconsumption. Because the energy drinks are intended for consuming at room or refrigerated temperatures, they readily support rapid consumption within a short period of time. Smaller (shot- sized) versions of these energy drinks further promote such rapid consumption and overconsumption. Further still, the addition of savory flavors and sweeteners add to the likelihood of consumption of more than a single serving of these energy drinks.

[00199] As another example, conventional energy drinks pose an increased risk in persons exhibiting caffeine naivety. Although 400 mg/day or less of caffeine is considered safe for an average adult, lesser amounts have resulted in adverse health incidents for people who are na ^' ive to caffeine. Caffeine toxicity can occur in children and young adults unaccustomed to high caffeine intake. This is exacerbated by the fact that energy drinks may be readily available in stores and in the homes of such caffeine na ^' ive individuals.

[00200] As another example, conventional energy drinks pose an increased risk in persons exhibiting caffeine sensitivity. Caffeine sensitive individuals, such as pregnant women and people with anxiety disorders, bipolar disorders, bleeding disorders, and certain heart conditions, are more likely to develop adverse reactions at lower levels of caffeine intake. Additionally, caffeine may also increase blood pressure in people having high blood pressure who are not habitual consumers of caffeine. Because conventional energy drinks are often marketed with little or no warning of such adverse consequences on their labels, and may be subjected to minimal regulatory requirements, they present an increased risk of exposing a sensitive person to caffeine.

[00201] These exemplary drawbacks of conventional energy drinks can be mitigated or otherwise avoided by the improved energy drinks disclosed herein.

[00202] For example, the HBF formulation for fortifying the beverage does not contain any caffeine. Instead, the HBF formulation relies on the caffeine already present in the beverage. In this manner, consumers are better able to gauge their caffeine intake based on their prior experiences with the beverage. Furthermore, because the consumers are able to select or otherwise control their level of caffeine intake by selection of beverages they are familiar with and accustomed to, the risk of caffeine toxicity (e.g., even in caffeine naive or caffeine sensitive individuals) is lowered.

[00203] As another example, because the beverage being fortified with the HBF formulation is often a hot beverage, the elevated temperature of the beverage itself decreases the risk of rapid consumption, overdose, and use with alcohol.

[00204] As another example, the beverage being fortified with the HBF formulation may have properties (e.g., an astringent or bitter taste) that further reduces the risk of rapid consumption, overdose, and use with alcohol.

[00205] Accordingly, the general inventive concepts encompass nutritional compositions (i.e., HBF formulations) that are suitable for transforming a beverage, such as coffee or tea, into an improved energy drink.

[00206] The nutritional compositions can take any suitable product form, such as a powdered nutritional composition (which may be reconstituted to form a nutritional liquid) or a liquid nutritional composition. The nutritional compositions are generally suitable for oral

consumption.

[00207] The nutritional compositions can be packaged as a single serving stickpacks, as well as other packaging embodiments like small single serving plastic containers, creamer cups, or large bulk containers.

[00208] The nutritional compositions are intended to be readily dispersed into any prepared coffee or tea drink by manual stirring with a spoon, regardless of the type, style, and brand.

[00209] The intensity of the energy boost from the HBF formulations depends on the concentration of caffeine in the base beverage. The amount of caffeine in different types, styles, and brands of coffee typically varies from 40 mg per serving to as much as 400 mg per serving. Tea usually contains about half the amount of caffeine as compared to coffee, but with similarly varying concentrations depending on type, style, and brand. In this manner, the HBF

formulations allow the consumer to control the amount of energy boost obtained by selecting a beverage that provides a level of caffeine with which the consumer is already comfortable or otherwise accustomed. For example, selection of a milder coffee (having a lower amount of caffeine) can provide an energy boost appropriate for a person used to consuming this particular type of coffee. This is in stark contrast to the "one-size-fits-all" approach of conventional energy drinks.

[00210] The nutritional compositions can include any one or more of the ingredients or additives described herein. In some embodiments, the HBF formulation includes ingredients and/or additives that are able to transform a beverage into an improved energy drink that further provides nutritional and/or therapeutic benefits. The improved energy drink can reduce the chance of caffeine toxicity, for example, resulting from overdose, rapid consumption, exposure of caffeine na ^' ive or susceptible individuals, and use with alcohol.

[00211] In certain exemplary embodiments, a nutritional composition for fortifying a hot beverage is provided, wherein consumption of the fortified beverage is effective to increase energy levels. The nutritional composition is substantially free of caffeine, while the hot beverage includes caffeine.

[00212] In some exemplary embodiments, the nutritional composition is a powdered nutritional composition. In some exemplary embodiments, the nutritional composition is a liquid nutritional composition. In some exemplary embodiments, the hot beverage is coffee. In some exemplary embodiments, the hot beverage is tea.

[00213] In some exemplary embodiments, the nutritional composition includes free amino acids and at least one B vitamin selected from the group consisting of thiamine (Bl), riboflavin (B2), niacin (B3), niacineamide (B3), pantothenic acid (B5), pyridoxine (B6), pyridoxamine (B6), pyridoxal (B6), biotin (B7), folic acid (B9), folinic acid (B9), cyanocobalamin (B12), hydroxycobalamin (B12), methylcobalamin (B12), and combinations thereof.

[00214] In some exemplary embodiments, the nutritional composition includes free amino acids and a plurality of B vitamins selected from the group consisting of thiamine (Bl), riboflavin (B2), niacin (B3), niacineamide (B3), pantothenic acid (B5), pyridoxine (B6), pyridoxamine (B6), pyridoxal (B6), biotin (B7), folic acid (B9), folinic acid (B9), cyanocobalamin (B 12), hydro xycobalamin (B12), methylcobalamin (B12), and combinations thereof.

[00215] In some exemplary embodiments, the free amino acids are selected from the group consisting of tyrosine, phenylalanine, taurine, valine, leucine, isoleucine, alanine, glutamine, lysine, aspartic acid, glutamic acid, proline, cysteine, ornithine, selenocysteine, threonine, methionine, histidine, tryptophan, asparagine, glycine, serine, and combinations thereof.

[00216] In some exemplary embodiments, the nutritional composition includes 10% to 70% free amino acids by weight of the nutritional composition.

[00217] In some exemplary embodiments, the nutritional composition includes 2% to 40% of at least one B vitamin by weight of the nutritional composition.

[00218] In some exemplary embodiments, the nutritional composition includes at least one of the additives described herein. In some exemplary embodiments, the nutritional composition includes a plurality of the additives described herein.

[00219] To the extent that the terms "include," "includes," or "including" are used in the specification or the claims, they are intended to be inclusive in a manner similar to the term "comprising" as that term is interpreted when employed as a transitional word in a claim.

Furthermore, to the extent that the term "or" is employed (e.g., A or B), it is intended to mean "A or B or both A and B." When the applicants intend to indicate "only A or B but not both," then the term "only A or B but not both" will be employed. Thus, use of the term "or" herein is the inclusive, and not the exclusive use. In the present disclosure, the words "a" or "an" are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[00220] All percentages, parts, and ratios as used herein are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients 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. [00221] All ranges and parameters, including but not limited to percentages, parts, and ratios, disclosed herein are understood to encompass any and all sub-ranges assumed and subsumed therein, and every number between the endpoints. For example, a stated range of "1 to 10" should be considered to include any and all subranges between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges beginning with a minimum value of 1 or more (e.g., 1 to 6.1), and ending with a maximum value of 10 or less (e.g., 2.3 to 9.4, 3 to 8, 4 to 7), and finally to each number 1 , 2, 3, 4, 5, 6, 7, 8, 9, and 10 contained within the range.

[00222] All combinations of method or process steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.

[00223] The nutritional compositions may comprise, consist of, or consist essentially of the elements of the nutritional compositions as described herein, as well as any additional or optional element described herein or otherwise useful in nutritional composition applications.

[00224] In some embodiments, it may be possible to utilize the various inventive concepts in combination with one another (e.g., one or more of the first, second, third, etc., exemplary embodiments may be utilized in combination with each other). Additionally, any particular element recited as relating to a particularly disclosed embodiment should be interpreted as available for use with all disclosed embodiments, unless incorporation of the particular element would be contradictory to the express terms of the embodiment. Additional advantages and modifications will be readily apparent to those skilled in the art. Therefore, the disclosure, in its broader aspects, is not limited to the specific details presented therein, the representative apparatus, or the illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the general inventive concepts.