Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans (Fenugreek)

• ClinicalTrials.gov Identifier: NCT00597350
• Recruitment Status: Completed
• First Posted: January 18, 2008
• Last Update Posted: December 18, 2015
• Sponsor: Pennington Biomedical Research Center
• Collaborator: Louisiana State University Health Sciences Center in New Orleans
• Information provided by (Responsible Party): Frank Greenway, Pennington Biomedical Research Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Diabetes Mellitus	Dietary Supplement: Trigonella foenum-graecum (fenugreek)

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Pilot Study of the Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
• Study Start Date: November 2007
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: February 2008

Groups and Cohorts

Group/Cohort	Intervention/treatment
1; Group with diabetes mellitus	Dietary Supplement: Trigonella foenum-graecum (fenugreek); 2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart

Outcome Measures

Primary Outcome Measures :

1. Area under the curve for insulin and glucose [ Time Frame: 4 hrs. after eating the bread ]

Secondary Outcome Measures :

1. Any adverse event experienced by the subjects [ Time Frame: 2 times, 1 wk. apart ]

Biospecimen Retention:   Samples Without DNA

Whole blood drawn for glucose and insulin levels.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Community sample

Criteria

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.

Contacts and Locations

Locations

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

Louisiana State University Health Sciences Center in New Orleans

Investigators

• Principal Investigator: Frank Greenway, M.D.; Pennington Biomedical Research Center
• Study Director: Amber Torres, RD, LDN; Pennington Biomedical Research Center

More Information

Publications:

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. doi: 10.1017/S0007114507657869.

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.

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):E617-23. doi: 10.1152/ajpendo.1999.277.4.E617.

• Responsible Party: Frank Greenway, Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00597350
• Other Study ID Numbers: PBRC 27031
• First Posted: January 18, 2008
• Last Update Posted: December 18, 2015
• Last Verified: December 2015

Keywords provided by Frank Greenway, Pennington Biomedical Research Center:

Fenugreek; Trigonella foenum-graecum; Diabetes mellitus; Blood sugar; Insulin; Glucose

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases