Compositions and methods for glycemic control of subjects with impaired fasting glucose

• US 9,610,276 B2
• Filed: 07/29/2015
• Issued: 04/04/2017
• Est. Priority Date: 06/17/2013
• Status: Active Grant

• Current Assignee: 1242753 Ontario Incorporated
• Original Assignee: KGK Synergize Incorporated
• Inventors: Guthrie, Najla
• Primary Examiner(s): SHIAO, REI TSANG
• Application Number:
  US14/812,256
• Publication Number:
  US 20150328184A1
• Time in Patent Office: 615 Days
• Field of Search: 514458, 514456, 514473
• 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 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 38/168 from plants
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

Compositions and methods for providing anti-diabetic and anti-hyperlipidemia benefits to diabetic subjects currently on medication but not meeting recommended targets for blood glucose, HbA1c, blood pressure and total cholesterol.

Claims

1. A method comprising administering an effective amount of a composition to a subject diagnosed with diabetes, wherein the subject is currently taking one or more prescribed medications for control of diabetes, wherein the one or more prescribed medications are selected from the group consisting of:

metformin, acarbose, fibrates, thiazolidienodiones, Sulphonylureas, and combinations thereof, wherein the subject does not have the following;

HbA1c≦

7%;

LDL-C≦

100 mg/dL;

total cholesterol≦

200 mg/dL; and

systolic blood pressure≦

130 mmHg, wherein after a predetermined period of supplementation with the composition, the subject has at least one of the following;

HbA1c≦

7%;

LDL-C≦

100 mg/dL;

total cholesterol≦

200 mg/dL; and

systolic blood pressure≦

130 mmHg; and

wherein the composition comprises at least one polymethoxyflavone.

2. The method of claim 1, wherein the one or more prescribed medications are metformin.

3. The method of claim 1, wherein the composition comprises about 300 mg of the at least one polymethoxyflavone.

4. The method of claim 1, wherein the composition comprises greater than or equal to approximately 62% of the at least one polymethoxyflavone.

5. The method of claim 1, wherein the composition further comprises at least one limonoid, at least one flavonoid and at least one tocotrienol.

6. The method of claim 5, wherein the composition comprises 1-500 mg/day of the at least one liminoid.

7. The method of claim 6, wherein the composition comprises 1-100 mg/day of the at least one liminoid.

8. The method of claim 5, wherein the composition comprises 200-5,000 mg/day of the at least one flavinoid.

9. The method of claim 8, wherein the composition comprises 500-1,500 mg/day of the at least one flavinoid.

10. The method of claim 5, wherein the composition comprises 1-1,200 mg/day of the at least one tocotrienol.

11. The method of claim 10, wherein the composition comprises 1-60 mg/day of the at least one tocotrienol.

12. The method of claim 1, wherein the composition further comprises soy protein.

13. The method of claim 12, wherein the composition comprises 1-500 mg/day of the soy protein.

14. The method of claim 13, wherein the composition comprises 25-100 mg/day of the soy protein.

15. The method of claim 5, wherein the composition comprises about 300 mg of the at least one polymethoxyflavone, and further comprises about 30 mg of at least one liminoid, about 200 mg of at least one flavinoid, and about 10 mg of at least one tocotrienol.

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

17. The method of claim 1, wherein the predetermined period of supplementation is at least 12 weeks.

18. The method of claim 17, wherein the predetermined period of supplementation is at least 24 weeks.

19. The method of claim 1, wherein the composition is administered orally, transdermally, rectally, intravenously, intramuscularly, intraperitoneally, subcutaneously, topically, or by inhalation.