Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

Diabetes Mellitus Clinical Trial

— Fenugreek  

Official title:

Pilot Study of the Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597350
• Other study ID #: PBRC 27031
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: December 17, 2015
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if bread containing fenugreek reduces blood sugar and insulin compared to identical bread without fenugreek.

Description:

Trigonella foenum-graecum (fenugreek) has been used in traditional medicine for the treatment of diabetes. Fenugreek has been demonstrated to lower blood glucose in response to a glucose load while leaving the levels of serum insulin unaffected in rodents. This effect of lowering blood sugar without changing insulin levels demonstrates improved insulin action. Fenugreek has also been shown to decrease glucose absorption by inhibiting intestinal disaccharidases. Fenugreek decreases glycohemoglobin in diabetic rodents. An amino acid extracted from fenugreek seeds, 4-hydroxyisoleucine, decreases glucose and insulin in diabetic rodents, improves glucose tolerance and stimulates insulin secretion from isolated pancreatic rodent islets.

Fenugreek imparts a bitter taste to products into which it is placed, and this property has limited its use in treating diabetes. Dr. Losso and his associates developed a process that allows incorporation of fenugreek into bread and other bakery goods without imparting a bitter taste, and the success of this process was confirmed in taste testing. This study is designed to evaluate the effect of fenugreek bread made by Dr. Losso's proprietary process on glucose and insulin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Healthy male or female with diet controlled diabetes mellitus.

• Between 18 and 70 years of age.

Exclusion criteria:

• Pregnant or nursing.

• Taking medication for diabetes or a medication like oral cortisone that is known to affect blood sugar or blood insulin.

• Taking any chronic medication that has not had a stable dose for 1 month or longer. Oral contraceptives are accepted.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Trigonella foenum-graecum (fenugreek)
2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

References & Publications (3)

Broca C, Gross R, Petit P, Sauvaire Y, Manteghetti M, Tournier M, Masiello P, Gomis R, Ribes G. 4-Hydroxyisoleucine: experimental evidence of its insulinotropic and antidiabetic properties. Am J Physiol. 1999 Oct;277(4 Pt 1):E617-23. — View Citation

Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br J Nutr. 2007 Mar;97(3):514-21. — View Citation

Xue WL, Li XS, Zhang J, Liu YH, Wang ZL, Zhang RJ. Effect of Trigonella foenum-graecum (fenugreek) extract on blood glucose, blood lipid and hemorheological properties in streptozotocin-induced diabetic rats. Asia Pac J Clin Nutr. 2007;16 Suppl 1:422-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve for insulin and glucose		4 hrs. after eating the bread	No
Secondary	Any adverse event experienced by the subjects		2 times, 1 wk. apart	No