IP Library Granted Patent US 10,646,462
Granted Patent B2
US 10,646,462 · App. 15/610,668 · Granted May 12, 2020

Compositions and methods for producing elevated and sustained ketosis

Inventors: Dominic Paul D'Agostino (Tampa, FL); Patrick Arnold (Champaign, IL); Shannon Kesl (Long Beach, CA)
Assignee: University of South Florida
A61K31/23A23L2/52A61K31/047A61K31/19A61K31/20A61K31/22A23V2002/00
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Quick Facts
Patent No.
US 10,646,462
App. No.
15/610,668
Granted
May 12, 2020
Kind
B2
Abstract

Beta-hydroxybutyrate mineral salts in combination with medium chain fatty acids or an ester thereof such as medium chain triglycerides were used to induce ketosis, achieving blood ketone levels of (2-7 mmol/L), with or without dietary restriction. The combination results in substantial improvements in metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance in a short period of time. Further, use of these supplements to achieve ketosis yields a significant elevation of blood ketones and reduction of blood glucose levels. Use of these substances does not adversely affect lipid profiles. By initiating rapid ketosis and accelerating the rate of ketoadaptation, this invention is useful for the avoidance of glucose withdrawal symptoms commonly experienced by individuals initiating a ketogenic diet, and minimizes the loss of lean body mass during dietary restriction.

Claims (29)

1. A composition for inducing ketosis, suppressing appetite, or promoting weight loss in a mammal, comprising therapeutically effective amounts of:

at least one medium chain fatty acid or ester thereof; and

a beta-hydroxybutyrate monomer salt mixture comprising a plurality of beta-hydroxybutyrate monomer salts with at least two beta-hydroxybutyrate monomer salts selected from the group consisting of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, arginine beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, and citrulline beta-hydroxybutyrate.

2. The composition of claim 1 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least one of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate.

3. The composition of claim 1 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least two of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate.

4. The composition of claim 1 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least three of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate.

5. The composition of claim 1 , wherein the beta-hydroxybutyrate monomer salt mixture comprises:

at least one of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate; and

at least one of arginine beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, or citrulline beta-hydroxybutyrate.

6. The composition of claim 1 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least one of arginine beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, or citrulline beta-hydroxybutyrate.

7. The composition of claim 1 , wherein the beta-hydroxybutyrate monomer salt mixture comprises a racemic DL-beta-hydroxybutyrate monomer salt.

8. The composition of claim 1 , further comprising at least one of 1,3-butanediol, ethyl acetoacetate, ethyl beta-hydroxybutyrate.

9. The composition of claim 1 , wherein the at least one medium chain fatty acid or ester thereof is selected from the group consisting of medium chain triglycerides, coconut oil, coconut milk powder, fractionated coconut oil, palm kernel oil, isolated hexanoic acid, isolated octanoic acid, isolated decanoic acid, ethoxylated triglycerides thereof, enone triglyceride derivatives thereof, aldehyde triglyceride derivatives thereof, monoglyceride derivatives thereof, diglyceride derivatives thereof, triglyceride derivatives thereof, alkyl esters thereof, and mixtures thereof.

10. The composition of claim 1 , further comprising at least one additional component selected from the group consisting of amino acids, amino acid metabolites, vitamins, minerals, coconut milk powder, electrolytes, NADH, tetrahydrobiopeterin, alpha-ketoglutaric acid, alpha lipoic acid, nutritional co-factors, calcium beta-methyl-beta-hydroxybutyrate, arginine alphaketoglutarate, sodium R-alpha lipoic acid, thiamine, riboflavin, niacin, pyridoxine, ascorbic acid, citric acid, malic acid, sodium benzoate, potassium sorbate, acesulfame K, aspartame, xanthan gum, non-toxic minerals salts, and combinations thereof.

11. The composition of claim 1 , wherein the composition is a dry powder.

12. A composition for inducing ketosis, suppressing appetite, or promoting weight loss, comprising therapeutically effective amounts:

at least one medium chain fatty acid or ester thereof; and

a beta-hydroxybutyrate monomer salt mixture comprising a plurality of beta-hydroxybutyrate monomer salts with at least two being sodium beta-hydroxybutyrate monomer salt, potassium beta-hydroxybutyrate monomer salt, calcium beta-hydroxybutyrate monomer salt, or magnesium beta-hydroxybutyrate monomer salt.

13. The composition of claim 12 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least two beta-hydroxybutyrate monomer salts of sodium, potassium, calcium, or magnesium.

14. A method of inducing ketosis, suppressing appetite, or promoting weight loss in a mammal, comprising administering the composition of claim 1 to a mammal.

15. The method of claim 14 , wherein administering the composition comprises administering a daily amount of about 2 grams to about 50 grams of the beta-hydroxybutyrate monomer salt mixture.

16. The method of claim 14 , wherein administering the composition comprises administering a daily amount of about 5 grams to about 30 grams of the beta-hydroxybutyrate monomer salt mixture.

17. The method of claim 14 , wherein administering the composition comprises administering a daily amount of about 10 grams to about 20 grams of the beta-hydroxybutyrate monomer salt mixture.

18. The method of claim 14 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least two of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate.

19. The method of claim 14 , wherein the beta-hydroxybutyrate monomer salt mixture comprises at least three of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate.

20. The method of claim 14 , wherein the mammal is a human.

21. The method of claim 14 , wherein administering the composition comprises administering a daily amount of about 5 grams to about 50 grams of the at least one medium chain fatty acid or ester thereof.

22. The method of claim 14 , wherein administering the composition comprises administering a daily amount of about 10 grams to about 40 grams of the at least one medium chain fatty acid or ester thereof.

23. The method of claim 14 , wherein administering the composition comprises administering a daily amount of about 15 grams to about 30 grams of the at least one medium chain fatty acid or ester thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 2, 2018
From: D'AGOSTINO, DOMINIC PAUL; ARNOLD, PATRICK; KESL, SHANNON
To: UNIVERSITY OF SOUTH FLORIDA
Reel/Frame 046069/0797 →
CONFIRMATORY LICENSE Recorded Mar 14, 2018
From: SOUTH FLORIDA, UNIVERSITY OF
To: NAVY, SECRETARY OF THE UNITED STATES OF AMERICA
Reel/Frame 045604/0859 →
Continuity (6)
Continuation 14860092 · Sep 21, 2015
Continuation 14455385 · Aug 8, 2014
Continuation In Part PCTUS2014031237 · Mar 19, 2014
Provisional Application 61926664 · Jan 13, 2014
Provisional Application 61803203 · Mar 19, 2013
Related Publication 20170266148A1 · Sep 21, 2017
Cited By (2)
US 12,310,938 US 12,439,945