Beta-hydroxybutyrate mixed salt compositions and methods of use

Patent metadata

Field	Value
Publication number	US-11896565-B2
Application number	US-202117557429-A
Country	US
Kind code	B2
Filing date	Dec 21, 2021
Priority date	Mar 11, 2016
Publication date	Feb 13, 2024
Grant date	Feb 13, 2024

Abstract

Ketogenic compositions including a plurality of beta-hydroxybutyrate (BHB) salts are formulated to induce or sustain ketosis in a subject to which the ketogenic compositions are administered. The BHB mixed salt is formulated to provide a biologically balanced set of cationic electrolytes and avoid detrimental health effects associated with imbalanced electrolyte ratios. A ketogenic composition includes BHB salts selected from sodium, potassium, calcium, and magnesium salts. The BHB composition may also include transition metal cations (e.g., zinc or iron), one or more BHB-amino acid salts, one or more ketone precursors, supplements, or other compounds that cause a rise in blood ketone levels without adding more electrolytes to the bloodstream, a short-, medium-, or long-chain fatty acid source, vitamins, minerals, flavorants, or other excipients.

First claim

The invention claimed is:

1. A composition for increasing ketone level in a subject, comprising:
a plurality of beta-hydroxybutyrate salts comprised of:
at least one beta-hydroxybutyrate salt selected from:
calcium beta-hydroxybutyrate; and
magnesium beta-hydroxybutyrate; and

at least one other beta-hydroxybutyrate salt selected from:
sodium beta-hydroxybutyrate;
potassium beta-hydroxybutyrate;
calcium beta-hydroxybutyrate; and
magnesium beta-hydroxybutyrate; and

at least one additional ketone body or ketone precursor selected from the group consisting of acetoacetate, ketone ester, amino acid salt of beta-hydroxybutyrate, and other ketone body or ketone precursor that causes a rise in blood ketone level without adding more electrolytes to the subject's bloodstream,
wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof.

2. The composition of claim 1 , wherein the other ketone body or ketone precursor that causes a rise in blood ketone level without adding more electrolytes to the subject's bloodstream is beta-hydroxybutyric acid.

3. The composition of claim 1 , wherein the other ketone body or ketone precursor that causes a rise in blood ketone level without adding more electrolytes to the subject's bloodstream is not a ketone body ester or acetoacetate.

4. The composition of claim 1 , wherein the other ketone body or ketone precursor that causes a rise in blood ketone level without adding more electrolytes to the subject's bloodstream is acetoacetate.

5. The composition of claim 1 , wherein the plurality of beta-hydroxybutyrate salts are characterized by at least one of:
10% to 70% by weight of calcium beta-hydroxybutyrate;
10% to 70% by weight of magnesium beta-hydroxybutyrate;
10% to 70% by weight of sodium beta-hydroxybutyrate; or
10% to 70% by weight of potassium beta-hydroxybutyrate.

6. The composition of claim 1 , wherein the composition comprises a greater total weight of calcium and magnesium beta-hydroxybutyrate salts than a total weight of sodium and potassium beta-hydroxybutyrate salts.

7. The composition of claim 1 , wherein the composition comprises at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate.

8. The composition of claim 1 , wherein the composition comprises calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, and at least one of sodium beta-hydroxybutyrate or potassium beta-hydroxybutyrate.

9. The composition of claim 1 , wherein the composition comprises calcium beta-hydroxybutyrate and magnesium beta-hydroxybutyrate.

10. The composition of claim 9 , wherein the composition further comprises at least one of sodium beta-hydroxybutyrate or potassium beta-hydroxybutyrate.

11. The composition of claim 1 , further comprising at least one of vitamin, lithium, chromium, manganese, cobalt, copper, zinc, iron, molybdenum, selenium, amino acid, flavoring agent, essential oil, natural sweetener, artificial sweetener, or other supplement.

12. The composition of claim 1 , further comprising at least one of anticaking agent, flow agent, moisture absorber, aluminosilicate, ferrocyanide, carbonate salt, bicarbonate salt, silicate, phosphate, talcum, or powdered cellulose.

13. A composition for increasing ketone level in a subject, comprising:
a plurality of beta-hydroxybutyrate salts comprising calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, and optionally at least one of:
sodium beta-hydroxybutyrate; or
potassium beta-hydroxybutyrate; and

at least one additional ketone body or precursor selected from the group consisting of acetoacetate, ketone ester, amino acid salt of beta-hydroxybutyrate, and other ketone body or ketone precursor that causes a rise in blood ketone level without adding more electrolytes to the subject's bloodstream,
wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof.

14. The composition of claim 13 , wherein the beta-hydroxybutyrate salts comprise:
calcium beta-hydroxybutyrate;
magnesium beta-hydroxybutyrate; and
at least one other beta-hydroxybutyrate salt selected from:
sodium beta-hydroxybutyrate;
potassium beta-hydroxybutyrate; and
amino acid salts of beta-hydroxybutyrate.

15. The composition of claim 14 , wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate.

16. The composition of claim 14 , wherein the beta-hydroxybutyrate salts comprise at least 30% by combined weight of calcium beta-hydroxybutyrate and magnesium beta-hydroxybutyrate.

17. The composition of claim 16 , wherein the beta-hydroxybutyrate salts further comprise at least one of sodium beta-hydroxybutyrate or potassium beta-hydroxybutyrate.

18. The composition of claim 1 , wherein the composition comprises only one of calcium beta-hydroxybutyrate or magnesium beta-hydroxybutyrate.

19. The composition of claim 14 , wherein the composition comprises only one of sodium beta-hydroxybutyrate or potassium beta-hydroxybutyrate.

20. A composition for increasing ketone level in a subject, comprising:
at least three beta-hydroxybutyrate salts selected from:
calcium beta-hydroxybutyrate;
magnesium beta-hydroxybutyrate;
sodium beta-hydroxybutyrate; and
potassium beta-hydroxybutyrate;

at least one additional ketone body or precursor selected from the group consisting of acetoacetate, ketone ester, amino acid salt of beta-hydroxybutyrate, and other ketone body or ketone precursor that causes a rise in blood ketone level without adding more electrolytes to the subject's bloodstream; and
at least one of vitamin, lithium, chromium, manganese, cobalt, copper, zinc, iron, molybdenum, selenium, amino acid, flavoring agent, essential oil, natural sweetener, artificial sweetener, or other supplement,
wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof.

21. The composition of claim 1 , further comprising at least one short chain fatty acid having fewer than 6 carbons, or a mono-, di- or triglyceride, or other ester of the at least one short chain fatty acid.

22. The composition of claim 13 , further comprising at least one short chain fatty acid having fewer than 6 carbons, or a mono-, di- or triglyceride, or other ester of the at least one short chain fatty acid.

23. The composition of claim 20 , further comprising at least one short chain fatty acid having fewer than 6 carbons, or a mono-, di- or triglyceride, or other ester of the at least one short chain fatty acid.

Assignees

• Axcess Global Sciences Llc

Inventors

• Millet Gary

Classifications

• A61K31/19 Primary

  Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) · CPC title

• A23L33/12

  Fatty acids or derivatives thereof · CPC title

• A23L33/16

  Inorganic salts, minerals or trace elements · CPC title

• A23L33/175

  Amino acids · CPC title

• A61K9/006

  Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays · CPC title