# US 12,599,579 B2 · Compositions and compounds containing ketone bodies and/or ketone body precursors and one or more amino acids

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- Number: US 12,599,579 B2
- Document ID: US12599579B2
- Status: Granted
- Kind: B2
- Application number: 19/261,853
- Filed: 2025-07-07
- Published: 2025-10-30
- Granted: 2026-04-14
- Earliest claimed: 2016-04-19
- Assignees: Axcess Global Sciences, LLC
- Applicants: Axcess Global Sciences, LLC
- Inventors: Gary Millet; Ryan Lowery; Jacob Wilson; Terry Lacore
- Web page: https://patentgrep.com/patent/US12599579B2

## CPC

- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Compositions and methods for administering ketone bodies to a subject include a ketone body or ketone body precursor 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 1)

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.

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 1)

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.

### Claim 17 (depends on 1)

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.

### Claim 18 (depends on 17)

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

### Claim 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.

### Claim 20 (depends on 19)

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.

### Claim 21 (depends on 19)

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.

### Claim 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.
