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

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ClinicalTrials.gov Identifier: NCT00597350
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Primary Completion Date : January 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00597350     History of Changes
Other Study ID Numbers: PBRC 27031
First Posted: January 18, 2008    Key Record Dates
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
Fenugreek seed meal
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs