The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome

NCT ID: NCT06114134

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-02-20

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.

Conditions

Metabolic Syndrome; Complementary Therapies; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Fenobet

Intervention Type: DIETARY_SUPPLEMENT

receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Fenobet

receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nazli Namazi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

97-1151

Identifier Type: -

Identifier Source: org_study_id