Branched chain fatty acids for prevention or treatment of gastrointestinal disorders

• US 10,258,587 B2
• Filed: 11/17/2015
• Issued: 04/16/2019
• Est. Priority Date: 09/17/2007
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Brenna, James Thomas, Ran-Ressler, Rinat
• Primary Examiner(s): Fetterolf, Brandon J
• Assistant Examiner(s): Matos Negron, Taina D
• Application Number:
  US14/943,500
• Publication Number:
  US 20160095833A1
• Time in Patent Office: 1,246 Days
• Field of Search: 514183
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/127 Antibiotics
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/20 having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: C12N 1/20 Bacteria; Culture media therefor
• CPC Class Codes: C12N 1/38 Chemical stimulation of growth or activity by addition of chemical compounds which are not essential growth factors; Stimulation of growth by removal of a chemical compound C12N1/34 takes precedence
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention is directed to a method of preventing or treating a gastrointestinal condition in a subject, that includes administering one or more branched chain fatty acid to the subject under conditions effective to prevent or treat the gastrointestinal condition in the subject. The present invention is also directed to methods of promoting gastrointestinal health in a subject and propagation of probiotic organisms. Also disclosed is a formulation which includes one or more branched chain fatty acid and an aqueous phase emulsified with the one or more branched chain fatty acids, where the formulation includes over 25 wt % of the one or more branched chain fatty acid.

Claims

1. A method of treating a gastrointestinal condition in a subject, said method comprising:

selecting a subject in need of treatment of the gastrointestinal condition, and

administering a composition comprising one or more branched chain fatty acid to the subject under conditions effective to treat the gastrointestinal condition in the subject,

wherein the one or more branched chain fatty acid is a C₁₁ to C₂₆ mono- or di-alkyl-substituted branched chain fatty acid or mixture thereof, wherein the one or more branched chain fatty acid comprises at least one mono-alkyl-substituted iso- or anteiso-branched chain fatty acid, wherein the gastrointestinal condition is associated with inflammation, and wherein the composition is not milk or colostrum.

2. The method of claim 1, wherein the gastrointestinal condition is mediated by infection of the subject'"'"'s gastrointestinal tract by a pathogenic bacteria.

3. The method of claim 1, wherein the gastrointestinal condition is necrotizing enterocolitis.

4. The method of claim 1, wherein the gastrointestinal condition is a disease of the intestine involving inflammation.

5. The method of claim 4, wherein the gastrointestinal condition is inflammatory bowel disease.

6. The method of claim 1, wherein the at least one mono-alkyl-substituted iso- or anteiso-branched chain fatty acid is selected from the group consisting of iso-dodecanoic acid, iso-tridecanoic acid, anteiso-tridecanoic acid, iso-tetradecanoic acid, iso-pentadecanoic acid, anteiso-pentadecanoic acid, iso-hexadecanoic acid, anteiso-hexadecanoic acid, iso-heptadecanoic acid, anteiso-heptadecanoic acid, iso-octadecanoic acid, iso-eicosanoic acid, anteiso-heneicosanoic acid, iso-dodecanoic acid, iso-tetracosanoic acid, iso-pentacosanoic acid, anteiso-pentacosanoic acid, iso-hexacosanoic acid, and mixtures thereof.

7. The method of claim 6, wherein the at least one mono-alkyl-substituted iso- or anteiso-branched chain fatty acid is selected from the group consisting of iso-hexadecanoic acid, anteiso-hexadecanoic acid, and a mixture thereof.

8. The method of claim 1, wherein the one or more branched chain fatty acid is selected from the group consisting of saturated and monounsaturated fatty acids and mixtures thereof.

9. The method of claim 8, wherein the one or more branched chain fatty acid is a branched form of a fatty acid selected from the group consisting of an octanoic acid, a decanoic acid, a lauric acid, a myristic acid, a palmitic acid, a stearic acid, an eicosanoic acid, a palmitoleic acid, an oleic acid, and mixtures thereof.

10. The method of claim 1, wherein the subject is human.

11. The method of claim 10, wherein the subject is an infant.

12. The method of claim 11, wherein the subject is a newborn infant.

13. The method of claim 10, wherein the subject is a child.

14. The method of claim 10, wherein the subject is an adult.

15. The method of claim 1, wherein the composition comprises at least 25 wt % of the one or more branched chain fatty acids.

16. The method of claim 1, wherein the composition comprises at least 20 wt % of the one or more branched chain fatty acids.

17. The method of claim 1, wherein the composition comprises at least 10 wt % of the one or more branched chain fatty acids.

18. The method of claim 1, wherein the composition comprises at least 5 wt % of the one or more branched chain fatty acids.

19. The methods of claim 1, wherein the composition comprises at least 2 wt % of the one or more branched chain fatty acids.

20. The method of claim 1, wherein the composition is in the form of a tablet, capsule, powder, solution, suspension, or emulsion.

21. The method of claim 1, wherein the composition is in the form of an emulsion.

22. The method of claim 1, wherein the composition comprises the one or more branched chain fatty acids emulsified in an aqueous phase.

23. The method of claim 1, wherein the composition is a food product supplemented with the one or more branched chain fatty acid.

24. The method of claim 23, wherein the food product is selected from the group consisting of infant formula, baby food, a dietary supplement, vegetable oil, mayonnaise, yogurt, margarine, shortening, and a combination thereof.

25. The method of claim 23, wherein the food product is infant formula.

27. The method of claim 5, wherein the inflammatory bowel disease is Crohn'"'"'s disease.

48. The method of claim 1, wherein the one or more branched chain fatty acid further comprises 4,7-dimethyl-nonanoic acid, 4,8-dimethyl-decanoic acid, 8-methyl-undecanoic acid, 4,8-dimethyl-undecanoic acid, 4,9-dimethyl-undecanoic acid, 4,10-dimethyl-dodecanoic acid, 4,11-dimethyl-tridecanoic acid, 8,10-dimethyl-tetradecanoic acid, 4,12-dimethyl-tetradecanoic acid, 2-methyl hexadecanoic acid, 4,11-dimethyl-pentadecanoic acid, 4,13-dimethyl-pentadecanoic acid, or mixtures thereof.

26. A method of treatment or prevention of necrotizing enterocolitis in a subject, said method comprising:

selecting a subject in need of prevention or treatment of necrotizing enterocolitis, and

administering a composition comprising one or more branched chain fatty acid to the subject under conditions effective to prevent or treat the necrotizing enterocolitis in the subject, wherein the one or more branched chain fatty acid is a C₁₁ to C₂₆ mono- or di-alkyl-substituted branched chain fatty acid or mixture thereof, wherein the one or more branched chain fatty acid comprises at least one mono-alkyl-substituted iso- or anteiso-branched chain fatty acid, and wherein the composition is not milk or colostrum.

28. The method of claim 26, wherein the at least one mono-alkyl-substituted iso- or anteiso-branched chain fatty acid is selected from the group consisting of iso-dodecanoic acid, iso-tridecanoic acid, anteiso-tridecanoic acid, iso-tetradecanoic acid, iso-pentadecanoic acid, anteiso-pentadecanoic acid, iso-hexadecanoic acid, anteiso-hexadecanoic acid, iso-heptadecanoic acid, anteiso-heptadecanoic acid, iso-octadecanoic acid, iso-eicosanoic acid, anteiso-heneicosanoic acid, iso-dodecanoic acid, iso-tetracosanoic acid, iso-pentacosanoic acid, anteiso-pentacosanoic acid, iso-hexacosanoic acid, and mixtures thereof.

29. The method of claim 28, wherein the at least one mono-alkyl-substituted iso- or anteiso-branched chain fatty acid is selected from the group consisting of iso-hexadecanoic acid, anteiso-hexadecanoic acid, and a mixture thereof.

30. The method of claim 26, wherein the one or more branched chain fatty acid is selected from the group consisting of saturated and monounsaturated fatty acids and mixtures thereof.

31. The method of claim 30, wherein the one or more branched chain fatty acid is a branched form of a fatty acid selected from the group consisting of an octanoic acid, a decanoic acid, a lauric acid, a myristic acid, a palmitic acid, a stearic acid, an eicosanoic acid, a palmitoleic acid, an oleic acid, and mixtures thereof.

32. The method of claim 26, wherein the subject is human.

33. The method of claim 32, wherein the subject is an infant.

34. The method of claim 33, wherein the subject is a newborn infant.

35. The method of claim 32, wherein the subject is a child.

36. The method of claim 32, wherein the subject is an adult.

37. The method of claim 26, wherein the composition comprises at least 25 wt % of the one or more branched chain fatty acids.

38. The method of claim 26, wherein the composition comprises at least 20 wt % of the one or more branched chain fatty acids.

39. The method of claim 26, wherein the composition comprises at least 10 wt % of the one or more branched chain fatty acids.

40. The method of claim 26, wherein the composition comprises at least 5 wt % of the one or more branched chain fatty acids.

41. The methods of claim 26, wherein the composition comprises at least 2 wt % of the one or more branched chain fatty acids.

42. The method of claim 26, wherein the composition is in the form of a tablet, capsule, powder, solution, suspension, or emulsion.

43. The method of claim 26, wherein the composition is in the form of an emulsion.

44. The method of claim 26, wherein the composition comprises the one or more branched chain fatty acids emulsified in an aqueous phase.

45. The method of claim 26, wherein the composition is a food product supplemented with the one or more branched chain fatty acid.

46. The method of claim 45, wherein the food product is selected from the group consisting of infant formula, baby food, a dietary supplement, vegetable oil, mayonnaise, yogurt, margarine, shortening, and a combination thereof.

47. The method of claim 45, wherein the food product is infant formula.

49. The method of claim 26, wherein the one or more branched chain fatty acid further comprises 4,7-dimethyl-nonanoic acid, 4,8-dimethyl-decanoic acid, 8-methyl-undecanoic acid, 4,8-dimethyl-undecanoic acid, 4,9-dimethyl-undecanoic acid, 4,10-dimethyl-dodecanoic acid, 4,11-dimethyl-tridecanoic acid, 8,10-dimethyl-tetradecanoic acid, 4,12-dimethyl-tetradecanoic acid, 2-methyl hexadecanoic acid, 4,11-dimethyl-pentadecanoic acid, 4,13-dimethyl-pentadecanoic acid, or mixtures thereof.