The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome; Complementary Therapies

• Registration Number: NCT06114134
• Lead Sponsor: Tehran University of Medical Sciences

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.

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study Start: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Primary Completion: 2023-12-15
• Study Completion: 2024-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Lipid profile	baseline and 2 months	Low-Density Cholesterol (LDL-C)
Antropometric Indices	baseline and 2 months	Hip Circumference