Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

This study has been completed.
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center in New Orleans
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00597350
First received: January 9, 2008
Last updated: March 19, 2008
Last verified: March 2008

January 9, 2008
March 19, 2008
November 2007
January 2008   (final data collection date for primary outcome measure)
Area under the curve for insulin and glucose [ Time Frame: 4 hrs. after eating the bread ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00597350 on ClinicalTrials.gov Archive Site
Any adverse event experienced by the subjects [ Time Frame: 2 times, 1 wk. apart ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
Pilot Study of the 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood drawn for glucose and insulin levels.

Non-Probability Sample

Community sample

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
1
Group with diabetes mellitus
Intervention: Dietary Supplement: Trigonella foenum-graecum (fenugreek)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597350
PBRC27031
No
Frank Greenway, M.D., Pennington Biomedical Research Center
Pennington Biomedical Research Center
Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Frank Greenway, M.D. Pennington Biomedical Research Center
Study Director: Amber Torres, RD, LDN Pennington Biomedical Research Center
Pennington Biomedical Research Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP