IP Library › Granted Patent US 12,350,243
Granted Patent B2
US 12,350,243 · App. 18/977,541 · Granted Jul 8, 2025

Compositions and compounds containing beta-hydroxybutyrate and one or more amino acids

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
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Quick Facts
Patent No.
US 12,350,243
App. No.
18/977,541
Granted
Jul 8, 2025
Kind
B2
Abstract

Compositions and methods for administering ketone bodies to a subject include beta-hydroxybutyrate complexed with or coupled to at least one amino acid. The compositions and methods cause one or more 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.

Claims (30)

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

beta-hydroxybutyrate; and

at least one amino acid,

wherein the beta-hydroxybutyrate is complexed with or coupled to at least one amino acid.

2. The composition of claim 1 , wherein the composition comprises a complex of the beta-hydroxybutyrate and at least one amino acid.

3. The composition of claim 1 , wherein the composition comprises a compound of beta-hydroxybutyrate covalently bonded to at least one amino acid.

4. The composition of claim 1 , wherein the at least one amino acid is 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 beta-hydroxybutyrate comprises D,L-beta-hydroxybutyrate.

6. The composition of claim 1 , wherein the beta-hydroxybutyrate comprises 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 beta-hydroxybutyrate comprises greater than approximately 90% R-beta-hydroxybutyrate and less than approximately 10% S-beta-hydroxybutyrate.

8. The composition of claim 1 , wherein the beta-hydroxybutyrate comprises greater than approximately 95% R-beta-hydroxybutyrate and less than approximately 5% S-beta-hydroxybutyrate.

9. The composition of claim 1 , wherein the beta-hydroxybutyrate comprises greater than approximately 99% R-beta-hydroxybutyrate and less than approximately 1% S-beta-hydroxybutyrate.

10. The composition of claim 1 , wherein the composition provides a dose of from approximately 0.1 g to approximately 50 g of beta-hydroxybutyrate.

11. The composition of claim 1 , wherein the composition provides a dose of from about 0.1 g to about 20 g of beta-hydroxybutyrate.

12. The composition of claim 1 , wherein the composition provides a dose of from about 10 g to about 30 g of beta-hydroxybutyrate.

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

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

15. The composition of claim 1 , further comprising at least one additive selected from the group consisting of 1,3-butanediol, butyrate, butyric acid, tributyrin, acetoacetate esters, fatty acids, esters of 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 beta-hydroxybutyrate is selected from the group consisting of beta-hydroxybutyric acid, beta-hydroxybutyrate salts, beta-hydroxybutyrate 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:

R-beta-hydroxybutyrate; and

an 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 the R-beta-hydroxybutyrate is covalently bonded to the amino acid.

20. The composition of claim 19 , wherein the beta-hydroxybutyrate comprises S-beta-hydroxybutyrate, and wherein the composition is enriched with the R-beta-hydroxybutyrate relative to the S-beta-hydroxybutyrate.

21. A composition for administering beta-hydroxybutyrate to a subject in need thereof, comprising:

beta-hydroxybutyrate, wherein the beta-hydroxybutyrate is selected from the group consisting of beta-hydroxybutyric acid, beta-hydroxybutyrate salts, beta-hydroxybutyrate esters, and combinations thereof;

at least one amino acid complexed with or coupled to the beta-hydroxybutyrate, wherein the amino acid is 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, taurine, and combinations thereof; and

at least one additive selected from the group consisting of 1,3-butanediol, butyrate, butyric acid, tributyrin, acetoacetate esters, fatty acids, esters of 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)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2024
From: MILLET, GARY; LOWERY, RYAN; WILSON, JACOB; LACORE, TERRY
To: AXCESS GLOBAL SCIENCES, LLC
Reel/Frame 069557/0676 →
Continuity (5)
Continuation 18219556 · Jul 7, 2023
Continuation 17367206 · Jul 2, 2021
Continuation In Part 15491924 · Apr 19, 2017
Provisional Application 62324798 · Apr 19, 2016
Related Publication 20250108020A1 · Apr 3, 2025
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