Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
The purpose of this study is to determine if bread containing fenugreek reduces blood sugar and insulin compared to identical bread without fenugreek.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pilot Study of the Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans|
- Area under the curve for insulin and glucose [ Time Frame: 4 hrs. after eating the bread ] [ Designated as safety issue: No ]
- Any adverse event experienced by the subjects [ Time Frame: 2 times, 1 wk. apart ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Whole blood drawn for glucose and insulin levels.
|Study Start Date:||November 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597350
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Frank Greenway, M.D.||Pennington Biomedical Research Center|
|Study Director:||Amber Torres, RD, LDN||Pennington Biomedical Research Center|