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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06114134
Other study ID # 97-1151
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date February 20, 2024

Study information

Verified date October 2023
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date February 20, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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


Intervention

Dietary Supplement:
Fenobet
receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting blood sugar (FBS) Fasting blood sugar in mg/dL will be reported baseline and 2 months
Primary Hemoglobin A1C (HbA1C) HbA1C will be reported in percentage baseline and 2 months
Secondary Lipid profile Total Cholesterol baseline and 2 months
Secondary Lipid profile Triglyceride baseline and 2 months
Secondary Lipid profile High-density Cholesterol (HDL-C) baseline and 2 months
Secondary Lipid profile Low-Density Cholesterol (LDL-C) baseline and 2 months
Secondary Antropometric Indices Weight baseline and 2 months
Secondary Antropometric Indices Body Mass Index baseline and 2 months
Secondary Antropometric Indices Waist Circumference baseline and 2 months
Secondary Antropometric Indices Hip Circumference baseline and 2 months
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