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
  Purpose

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


Condition Intervention
Diabetes Mellitus
Dietary Supplement: Trigonella foenum-graecum (fenugreek)

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Area under the curve for insulin and glucose [ Time Frame: 4 hrs. after eating the bread ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597350

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:
Responsible Party: Frank Greenway, M.D., Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00597350     History of Changes
Other Study ID Numbers: PBRC27031
Study First Received: January 9, 2008
Last Updated: March 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Fenugreek seed meal
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014