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Trial record 6 of 24 for:    fenugreek

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:
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Tracking Information
First Submitted Date January 9, 2008
First Posted Date January 18, 2008
Last Update Posted Date December 18, 2015
Study Start Date November 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2008)
Area under the curve for insulin and glucose [ Time Frame: 4 hrs. after eating the bread ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00597350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 19, 2008)
Any adverse event experienced by the subjects [ Time Frame: 2 times, 1 wk. apart ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
Official Title Pilot Study of the Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood drawn for glucose and insulin levels.
Sampling Method Non-Probability Sample
Study Population Community sample
Condition Diabetes Mellitus
Intervention Dietary Supplement: Trigonella foenum-graecum (fenugreek)
2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart
Study Groups/Cohorts 1
Group with diabetes mellitus
Intervention: Dietary Supplement: Trigonella foenum-graecum (fenugreek)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2008)
8
Original Actual Enrollment Same as current
Actual Study Completion Date February 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00597350
Other Study ID Numbers PBRC 27031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Frank Greenway, Pennington Biomedical Research Center
Study Sponsor Pennington Biomedical Research Center
Collaborators 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
PRS Account Pennington Biomedical Research Center
Verification Date December 2015