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Completed

NCT Number: NCT00597350

Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trigonella foenum-graecum (fenugreek)

Dietary Supplement

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

Primary outcomes

  1. Area under the curve for insulin and glucose

    Time frame: 4 hrs. after eating the bread

Secondary outcomes

  1. Any adverse event experienced by the subjects

    Time frame: 2 times, 1 wk. apart

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

Registry information

Official study title

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

Acronym: Fenugreek

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 18, 2008
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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