Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
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| First Received Date ICMJE | January 9, 2008 | ||||||||
| Last Updated Date | March 19, 2008 | ||||||||
| Start Date ICMJE | November 2007 | ||||||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Area under the curve for insulin and glucose [ Time Frame: 4 hrs. after eating the bread ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00597350 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Any adverse event experienced by the subjects [ Time Frame: 2 times, 1 wk. apart ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Whole blood drawn for glucose and insulin levels. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Community sample |
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| Condition ICMJE | Diabetes Mellitus | ||||||||
| Intervention ICMJE | Dietary Supplement: Trigonella foenum-graecum (fenugreek)
2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart |
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| Study Group/Cohort (s) | 1
Group with diabetes mellitus
Intervention: Dietary Supplement: Trigonella foenum-graecum (fenugreek) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 8 | ||||||||
| Completion Date | February 2008 | ||||||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00597350 | ||||||||
| Other Study ID Numbers ICMJE | PBRC27031 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Frank Greenway, M.D., Pennington Biomedical Research Center | ||||||||
| Study Sponsor ICMJE | Pennington Biomedical Research Center | ||||||||
| Collaborators ICMJE | Louisiana State University Health Sciences Center in New Orleans | ||||||||
| Investigators ICMJE |
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| Information Provided By | Pennington Biomedical Research Center | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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