The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Metabolic Syndrome, Complementary Therapies, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Fenobet
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenugreek extract<br>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<br>* receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)<br>|
| Placebo Comparator: Placebo<br>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<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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