The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06114134

Collaborator

(none)

Enrollment

Arms

3.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Complementary Therapies Diabetes Mellitus, Type 2	Dietary Supplement: Fenobet Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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.

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Feb 20, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fasting blood sugar (FBS) [baseline and 2 months]
Fasting blood sugar in mg/dL will be reported
Hemoglobin A1C (HbA1C) [baseline and 2 months]
HbA1C will be reported in percentage

Secondary Outcome Measures

Lipid profile [baseline and 2 months]
Total Cholesterol
Lipid profile [baseline and 2 months]
Triglyceride
Lipid profile [baseline and 2 months]
High-density Cholesterol (HDL-C)
Lipid profile [baseline and 2 months]
Low-Density Cholesterol (LDL-C)
Antropometric Indices [baseline and 2 months]
Weight
Antropometric Indices [baseline and 2 months]
Body Mass Index
Antropometric Indices [baseline and 2 months]
Waist Circumference
Antropometric Indices [baseline and 2 months]
Hip Circumference

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nazli Namazi, Assistant Professor, Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT06114134

Other Study ID Numbers:

97-1151

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Diabetes Mellitus, Type 2

Syndrome

Study Results

No Results Posted as of Nov 2, 2023