The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome (Fenobet)

November 1, 2023 updated by: Nazli Namazi, Tehran University of Medical Sciences

The Effect of Fenobet® Capsules (Fenugreek Seed Extract) on Glycemic Status, Lipid Pattern and Anthropometric Indices in People With Metabolic Syndrome: a Randomized, Double-blind, Controlled Clinical Trial.

The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. The eligible participants were allocated randomly to one of the two study groups (Fenobet, Placebo). Then, the eligible people were in one of two groups 1) receiving fenugreek extract, 2), receiving placebos and were examined for 8 weeks. At baseline and after two months of intervention, biochemical parameters, and anthropometric indices will be measured.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. According to the ATP criteria, a person who has at least 3 of the following 5 components was considered as metabolic syndrome.

After providing the necessary information about the study to patients, written informed consent will be obtained from eligible volunteers.

Inclusion criteria:

  • People with metabolic syndrome
  • Fasting sugar above 100 mg/dL
  • Both men and women
  • Age range 20-60 years Exclusion criteria
  • Injection of insulin or liraglutide
  • People under 20 years old and over 60 years old
  • having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer
  • Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months
  • Patients who are treated with a special diet such as vegetarianism or a special exercise program.
  • Allergy
  • Pregnant and lactating women The participants were allocated randomly to one of the two study groups (Fenobet, Placebo) by a random number table. Then, the eligible people were in one of two groups 1) receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals), 2), receiving placebos (3 capsules of 500 mg, 1 capsule half an hour before meals) and were examined for 8 weeks. It is worth noting that the participants were asked not to change their physical activity and diet during the study and to report any changes in the type and dosage of the drug to the researchers. The capsule and container intended for the placebo will be exactly the same size and color as the fenugreek capsule and a dark container will be chosen for the capsules. At baseline and after two months of intervention, biochemical parameters (fasting blood sugar, HbA1C, lipid profile, C-reactive protein), and anthropometric indices (weight, body mass index, waist circumference, Hip circumference) will be measured.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

People with metabolic syndrome

  • Fasting sugar above 100 mg/dL
  • Both men and women
  • Age range 20-60 years

Exclusion Criteria:

  • Injection of insulin or liraglutide
  • People under 20 years old and over 60 years old
  • having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer
  • Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months
  • Patients who are treated with a special diet such as vegetarianism or a special exercise program.
  • Allergy
  • Pregnant and lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fenugreek extract
Participants in this group will receive fenugreek extract capsules (500 mg/day, three times a day, 30 minutes before each main meal) along with common treatments
Dietary supplement: Fenobet
receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)
Placebo Comparator: Placebo
Participants in this group will receive starch with added color (similar to the color of fenugreek extract) capsules (with the same size and color of fenugreek) (500 mg/day, three times a day, 30 minutes before each main meal) along with common treatments
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood sugar (FBS)
Time Frame: baseline and 2 months
Fasting blood sugar in mg/dL will be reported
baseline and 2 months
Hemoglobin A1C (HbA1C)
Time Frame: baseline and 2 months
HbA1C will be reported in percentage
baseline and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: baseline and 2 months
Total Cholesterol
baseline and 2 months
Lipid profile
Time Frame: baseline and 2 months
Triglyceride
baseline and 2 months
Lipid profile
Time Frame: baseline and 2 months
High-density Cholesterol (HDL-C)
baseline and 2 months
Lipid profile
Time Frame: baseline and 2 months
Low-Density Cholesterol (LDL-C)
baseline and 2 months
Antropometric Indices
Time Frame: baseline and 2 months
Weight
baseline and 2 months
Antropometric Indices
Time Frame: baseline and 2 months
Body Mass Index
baseline and 2 months
Antropometric Indices
Time Frame: baseline and 2 months
Waist Circumference
baseline and 2 months
Antropometric Indices
Time Frame: baseline and 2 months
Hip Circumference
baseline and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-1151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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