Granted Patent B2

US 12,599,579 · App. 19/261,853 · Granted Apr 14, 2026

Inventors: Gary Millet (Salt Lake City, UT); Ryan Lowery (Tampa, FL); Jacob Wilson (Tampa, FL); Terry Lacore (Melissa, TX)

Assignee: AXCESS GLOBAL SCIENCES, LLC

A61K31/19A61K9/0053A61K31/522A61P3/04A61P25/28

Abstract

Claims (31)

1 . A composition for administering ketone bodies to a subject, comprising:

a ketone body component including a ketone body, ketone body precursor, or combination thereof; and

an amino acid component including at least one amino acid,

wherein at least a portion of the ketone body component is complexed with and/or coupled to at least a portion of the at least one amino acid component.

2 . The composition of claim 1 , wherein the composition comprises a complex of the ketone body component and the amino acid component.

3 . The composition of claim 1 , wherein the composition comprises a compound of, including a covalent bond between, the ketone body component and the amino acid component.

4 . The composition of claim 1 , wherein the amino acid component includes at least one amino acid selected from the group consisting of leucine, lysine, arginine, histidine, ornithine, creatine, agmatine, citrulline, isoleucine, valine, glutamine, tryptophan, tyrosine, phenylalanine, glycine, beta-alanine, proline, methionine, threonine, and taurine.

5 . The composition of claim 1 , wherein the ketone body component includes at least one of beta-hydroxybutyrate or acetoacetate in acid, salt and/or ester form.

6 . The composition of claim 1 , wherein the ketone body component includes R-beta-hydroxybutyrate and S-beta-hydroxybutyrate, and wherein the composition is enriched with the R-beta-hydroxybutyrate relative to the S-beta-hydroxybutyrate.

7 . The composition of claim 1 , wherein the ketone body component includes greater than approximately 90% R-beta-hydroxybutyrate and less than approximately 10% S-beta-hydroxybutyrate, or greater than approximately 95% R-beta-hydroxybutyrate and less than approximately 5% S-beta-hydroxybutyrate, or greater than approximately 99% R-beta-hydroxybutyrate and less than approximately 1% S-beta-hydroxybutyrate.

8 . The composition of claim 1 , wherein the ketone body precursor includes 1,3-butanediol or ester thereof.

9 . The composition of claim 1 , wherein the ketone body precursor includes at least one medium chain fatty acid or ester thereof.

10 . The composition of claim 1 , wherein the composition provides a dose of from approximately 0.1 g to approximately 50 g of the ketone body component.

11 . The composition of claim 1 , wherein the composition provides a dose of from about 0.1 g to about 20 g of the ketone body component.

12 . The composition of claim 1 , wherein the composition provides a dose of from about 10 g to about 30 g of the ketone body component.

13 . The composition of claim 1 , wherein the composition provides a dose of from approximately 0.5 g to approximately 10 g of the amino acid component.

14 . The composition of claim 1 , wherein the composition provides a dose of from approximately 0.5 g to approximately 2 g of the amino acid component.

15 . The composition of claim 1 , further comprising at least one additive selected from the group consisting of butyrate, butyric acid, tributyrin, short-chain fatty acids, esters of short-chain fatty acids, berberine, berberine metabolites, amino acid metabolites, vitamins, minerals, coconut milk powder, flavorings, caffeine, theacrine, colorings, binders, electrolytes, tetrahydrobiopterin, nucleic acids, alpha-ketoglutaric acid, alpha lipoic acid, nutritional co-factors, beta-methyl-beta-hydroxybutyrate, arginine alpha-ketoglutarate, R-alpha lipoic acid, thiamine, NAD+, NADH, riboflavin, FAD+, FADH, riboflavin-5-phosphate, niacin, nicotinic acid, niacinamide, inositol hexanicotinate, pyridoxine, pyridoxal, pyridoxamine, ascorbic acid, ascorbate salts, citric acid, malic acid, sodium benzoate, pyridoxal-5-phosphate, methylcobalamin, cyanocobalamin, adenosylcobalamin, hydroxycobalamin, pantothenic acid, pantetheine, potassium sorbate, acesulfame K, aspartame, sucralose, stevia, monk fruit extract, allulose, prebiotic fibers, xylo-oligosaccharides (XOS), galacto-oligosaccharides (GOS), mannan-oligosaccharides (MOS), isomalto-oligosaccharides (IMO), lipo-oligosaccharides (LOS), xanthan gum, organic gums, thickeners, and suspension agents.

16 . The composition of claim 1 , wherein the ketone body is selected from the group consisting of beta-hydroxybutyric acid, acetoacetic acid, beta-hydroxybutyrate salts, acetoacetate salts, beta-hydroxybutyrate esters, acetoacetate esters, and combinations thereof.

17 . A method of administering ketone bodies to a subject in need thereof comprising administering the composition of claim 1 to the subject, wherein the composition causes or results in at least one of weight loss, weight maintenance, reduced blood glucose level, maintenance of blood glucose level, increased muscle and physical performance, enhanced metabolic and cellular repair, improved detoxification and gut health, targeted bioavailability, sustained release and controlled absorption, increased metabolic efficiency, enhanced cellular uptake, minimized side effects, multifunctional therapeutics, improved focus, improved energy, improved cognitive function, improved mental acuity, treatment of traumatic brain injury, treatment of diabetes, treatment of neurological disorder, treatment of cancer, treatment of inflammatory condition, appetite suppression, anti-aging effects, anti-glycation effects, treatment of epilepsy, treatment of depression, improved performance, improved muscle mass, improved motor function, increased strength, increased metabolism, increased fat loss, increased fat oxidation, improved body composition, and improved mood.

18 . The method of claim 17 , wherein the composition is administered to the subject orally, enterally, parenterally, intravenously, nasally, sublingually, topically, or rectally.

19 . A composition for administering ketone bodies and increasing blood ketone level in a subject, comprising:

a ketone body component including a ketone body, ketone body precursor, or combination thereof, and

an amino acid component including at least one amino acid selected from the group consisting of leucine, lysine, arginine, histidine, ornithine, creatine, agmatine, citrulline, isoleucine, valine, glutamine, tryptophan, tyrosine, phenylalanine, glycine, beta-alanine, proline, methionine, threonine, and taurine;

wherein at least a portion of the ketone body component is complexed with and/or coupled to at least a portion of the at least one amino acid component.

20 . The composition of claim 19 , wherein the ketone body includes at least one of beta-hydroxybutyrate or acetoacetate in acid, salt and/or ester form.

21 . The composition of claim 19 , wherein the ketone body precursor includes at least one of 1,3-butanediol, medium chain fatty acid, or ester thereof.

22 . A composition for administering ketone bodies to a subject in need thereof, comprising:

a ketone body component including a ketone body, ketone body precursor, or combination thereof;

an amino acid component including at least one amino acid selected from the group consisting of leucine, lysine, arginine, histidine, ornithine, creatine, agmatine, citrulline, isoleucine, valine, glutamine, tryptophan, tyrosine, phenylalanine, glycine, beta-alanine, proline, methionine, threonine, and taurine, wherein at least a portion of the ketone body component is complexed with and/or coupled to at least a portion of the at least one amino acid component; and

at least one additive selected from the group consisting of butyrate, butyric acid, tributyrin, short-chain fatty acids, esters of short-chain fatty acids, berberine, berberine metabolites, amino acid metabolites, vitamins, minerals, coconut milk powder, flavorings, caffeine, theacrine, colorings, binders, electrolytes, tetrahydrobiopterin, nucleic acids, alpha- ketoglutaric acid, alpha lipoic acid, nutritional co-factors, beta-methyl-beta-hydroxybutyrate, arginine alpha-ketoglutarate, R-alpha lipoic acid, thiamine, NAD+, NADH, riboflavin, FAD+, FADH, riboflavin-5-phosphate, niacin, nicotinic acid, niacinamide, inositol hexanicotinate, pyridoxine, pyridoxal, pyridoxamine, ascorbic acid, ascorbate salts, citric acid, malic acid, sodium benzoate, pyridoxal-5-phosphate, methylcobalamin, cyanocobalamin, adenosylcobalamin, hydroxycobalamin, pantothenic acid, pantetheine, potassium sorbate, acesulfame K, aspartame, sucralose, stevia, monk fruit extract, allulose, prebiotic fibers, xylo-oligosaccharides (XOS), galacto-oligosaccharides (GOS), mannan-oligosaccharides (MOS), isomalto-oligosaccharides (IMO), lipo-oligosaccharides (LOS), xanthan gum, organic gums, thickeners, and suspension agents.

Assignments (1)

Continuity (6)

References Cited (400)