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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenugreek extract | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenobet | Dietary Supplement | receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Total Cholesterol | baseline and 2 months |
| Lipid profile | Triglyceride | baseline and 2 months |
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Inclusion Criteria:
People with metabolic syndrome
Exclusion Criteria:
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Dietary Supplement | Placebo |
|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |