Viewing Study NCT00597350


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Study NCT ID: NCT00597350
Status: COMPLETED
Last Update Posted: 2015-12-18
First Post: 2008-01-09
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
Sponsor: Pennington Biomedical Research Center
Organization:

Study Overview

Official Title: Pilot Study of the Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
Status: COMPLETED
Status Verified Date: 2015-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Fenugreek
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: