IP Library › Granted Patent US 12,251,362
Granted Patent B2
US 12,251,362 · App. 18/219,556 · Granted Mar 18, 2025

Administration of R-beta-hydroxybutyrate and related compounds in humans

Inventors: 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 12,251,362
App. No.
18/219,556
Granted
Mar 18, 2025
Kind
B2
Abstract

In various implementations, beta-hydroxybutyrate, related compounds, and/or one or more other compounds may be administered to an individual to cause weight loss, weight maintenance, elevate blood ketone levels, maintain blood ketone levels, reduce blood glucose levels, maintain blood glucose levels, improve energy, focus, mood, cognitive function, or aide with neurological or inflammatory disorders and/or combinations thereof.

Claims (34)

1. A beta-hydroxybutyrate composition formulated for ingestion by oral delivery as a beverage, dietary supplement, or food product, or as a dietary supplement for addition to water, beverage, or food product, to increase blood ketone level in a subject, comprising:

a liquid carrier comprising at least one of water, milk, drinkable liquid, coconut water, watermelon water, or electrolyte water;

beta-hydroxybutyrate, wherein the beta-hydroxybutyrate comprises beta-hydroxybutyric acid and optionally one or more beta-hydroxybutyrate salts; and

at least one additive selected from the group consisting of 1,3-butanediol, butyrate, butyric acid, tributyrin, acetoacetate esters, beta-hydroxybutyrate esters, fatty acids, esters of fatty acids, berberine, berberine metabolites, amino acids, 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.

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

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

4. The beta-hydroxybutyrate composition of claim 1 , wherein the composition provides a dose of from about 0.5 g to about 15 g of beta-hydroxybutyrate.

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

6. The beta-hydroxybutyrate composition of claim 1 , wherein the beta-hydroxybutyrate consists essentially of beta-hydroxybutyric acid.

7. The beta-hydroxybutyrate composition of claim 1 , wherein the beta-hydroxybutyrate comprises beta-hydroxybutyric acid and at least one beta-hydroxybutyrate salt selected from the group consisting of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, and amino acid salt of beta-hydroxybutyrate.

8. The beta-hydroxybutyrate composition of claim 1 , wherein the beta-hydroxybutyrate comprises R-beta-hydroxybutyrate and S-beta-hydroxybutyrate.

9. The beta-hydroxybutyrate composition of claim 1 , wherein the composition provides an amount of beta-hydroxybutyrate to cause weight loss, assist weight maintenance, elevate blood ketone level, maintain blood ketone level, reduce blood glucose level, maintain blood glucose level, improve focus, improve energy, improve cognitive function, improve mental acuity, treat traumatic brain injury, treat diabetes, treat neurological disorders, treat cancer, treat inflammatory conditions, suppress appetite, provide anti-aging effects, provide anti-glycation effects, treat epilepsy, treat depression, improve performance, improve muscle mass, improve motor function, increase strength, increase metabolism, promote fat loss, increase fat oxidation, improve body composition, improve mood, or as a medicament.

10. The beta-hydroxybutyrate composition of claim 1 , wherein the composition omits medium chain fatty acids and esters thereof.

11. The beta-hydroxybutyrate composition of claim 1 , wherein the beta-hydroxybutyrate comprises at least one beta-hydroxybutyrate salt selected from the group consisting of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, and amino acid salt of beta-hydroxybutyrate.

12. The beta-hydroxybutyrate composition of claim 1 , wherein the composition includes the at least one additive.

13. The beta-hydroxybutyrate composition of claim 8 , wherein the beta-hydroxybutyrate comprises greater than 90% R-beta-hydroxybutyrate and less than 10% S-beta-hydroxybutyrate.

14. The beta-hydroxybutyrate composition of claim 8 , wherein the beta-hydroxybutyrate comprises D,L-beta-hydroxybutyrate.

15. A beta-hydroxybutyrate composition formulated for ingestion by oral delivery as a beverage, dietary supplement, or food product, or as a dietary supplement for addition to water, beverage, or food product, to increase blood ketone level in a subject, comprising:

a liquid carrier comprising at least one of water, milk, drinkable liquid, coconut water, watermelon water, or electrolyte water;

beta-hydroxybutyrate, wherein the beta-hydroxybutyrate comprises beta-hydroxybutyric acid and one or more beta-hydroxybutyrate salts; and

optionally at least one additive selected from the group consisting of 1,3-butanediol, butyrate, butyric acid, tributyrin, acetoacetate esters, beta-hydroxybutyrate esters, fatty acids, esters of fatty acids, berberine, berberine metabolites, amino acids, 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 beta-hydroxybutyrate composition of claim 15 , wherein the composition provides a dose of from about 0.1 g to about 50 g of beta-hydroxybutyrate.

17. A beta-hydroxybutyrate composition formulated for ingestion by oral delivery as a beverage, dietary supplement, or food product to increase blood ketone level in a subject, comprising:

a liquid carrier comprising at least one of water, milk, drinkable liquid, coconut water, watermelon water, or electrolyte water;

beta-hydroxybutyrate, wherein the beta-hydroxybutyrate comprises R-beta-hydroxybutyric acid and optionally one or more R-beta-hydroxybutyrate salts; and

optionally at least one additive selected from the group consisting of 1,3-butanediol, butyrate, butyric acid, tributyrin, acetoacetate esters, beta-hydroxybutyrate esters, fatty acids, esters of fatty acids, berberine, berberine metabolites, amino acids, 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,

wherein the composition provides a dose of from about 0.1 g to about 50 g of beta-hydroxybutyrate.

18. The beta-hydroxybutyrate composition of claim 17 , wherein the composition provides a dose of from about 0.5 g to about 30 g of beta-hydroxybutyrate.

19. A beta-hydroxybutyrate composition formulated as a dietary supplement for addition to water, beverage, or food product to increase blood ketone level in a subject, comprising:

a liquid carrier comprising at least one of water, milk, drinkable liquid, coconut water, watermelon water, or electrolyte water;

beta-hydroxybutyrate, wherein the beta-hydroxybutyrate comprises R-beta-hydroxybutyric acid and optionally one or more R-beta-hydroxybutyrate salts; and

optionally at least one additive selected from the group consisting of 1,3-butanediol, butyrate, butyric acid, tributyrin, acetoacetate esters, beta-hydroxybutyrate esters, fatty acids, esters of fatty acids, berberine, berberine metabolites, amino acids, 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,

wherein the composition provides a dose of from about 0.1 g to about 50 g of beta-hydroxybutyrate.

20. The beta-hydroxybutyrate composition of claim 19 , wherein the composition provides a dose of from about 0.5 g to about 30 g of beta-hydroxybutyrate.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 7, 2023
From: LOWERY, RYAN; WILSON, JACOB; LACORE, TERRY
To: AXCESS GLOBAL SCIENCES, LLC
Reel/Frame 064189/0670 →
Continuity (4)
Continuation 17367206 · Jul 2, 2021
Continuation 15491924 · Apr 19, 2017
Provisional Application 62324798 · Apr 19, 2016
Related Publication 20230346723A1 · Nov 2, 2023
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