The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome
- Conditions
- Diabetes Mellitus, Type 2Metabolic SyndromeComplementary Therapies
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Fenobet
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
People with metabolic syndrome
- Fasting sugar above 100 mg/dL
- Both men and women
- Age range 20-60 years
- 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
- Arm && Interventions
Group Intervention Description Placebo 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 Fenugreek extract Fenobet 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
- 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