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Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

NCT ID: NCT00597350

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

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.

Conditions

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Diabetes Mellitus

Keywords

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Fenugreek Trigonella foenum-graecum Diabetes mellitus Blood sugar Insulin Glucose

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Group with diabetes mellitus

Trigonella foenum-graecum (fenugreek)

Intervention Type DIETARY_SUPPLEMENT

2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart

Interventions

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Trigonella foenum-graecum (fenugreek)

2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Greenway, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Amber Torres, RD, LDN

Role: STUDY_DIRECTOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br J Nutr. 2007 Mar;97(3):514-21. doi: 10.1017/S0007114507657869.

Reference Type BACKGROUND
PMID: 17313713 (View on PubMed)

Xue WL, Li XS, Zhang J, Liu YH, Wang ZL, Zhang RJ. Effect of Trigonella foenum-graecum (fenugreek) extract on blood glucose, blood lipid and hemorheological properties in streptozotocin-induced diabetic rats. Asia Pac J Clin Nutr. 2007;16 Suppl 1:422-6.

Reference Type BACKGROUND
PMID: 17392143 (View on PubMed)

Broca C, Gross R, Petit P, Sauvaire Y, Manteghetti M, Tournier M, Masiello P, Gomis R, Ribes G. 4-Hydroxyisoleucine: experimental evidence of its insulinotropic and antidiabetic properties. Am J Physiol. 1999 Oct;277(4):E617-23. doi: 10.1152/ajpendo.1999.277.4.E617.

Reference Type BACKGROUND
PMID: 10516120 (View on PubMed)

Other Identifiers

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PBRC 27031

Identifier Type: -

Identifier Source: org_study_id