Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of the Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Trigonella foenum-graecum (fenugreek)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Group with diabetes mellitus | Dietary Supplement: Trigonella foenum-graecum (fenugreek)<br>* 2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for insulin and glucose |  | 4 hrs. after eating the bread | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any adverse event experienced by the subjects |  | 2 times, 1 wk. apart | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fenugreek, Trigonella foenum-graecum, Diabetes mellitus, Blood sugar, Insulin, Glucose