Clinical trial NCT06114134: The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Complementary Therapies
Diabetes Mellitus, Type 2
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Fasting blood sugar (FBS)
timeFrame: baseline and 2 months
measure: Hemoglobin A1C (HbA1C)
timeFrame: baseline and 2 months
Secondary outcomes:
measure: Lipid profile
timeFrame: baseline and 2 months
measure: Lipid profile
timeFrame: baseline and 2 months
measure: Lipid profile
timeFrame: baseline and 2 months
measure: Lipid profile
timeFrame: baseline and 2 months
measure: Antropometric Indices
timeFrame: baseline and 2 months
measure: Antropometric Indices
timeFrame: baseline and 2 months
measure: Antropometric Indices
timeFrame: baseline and 2 months
measure: Antropometric Indices
timeFrame: baseline and 2 months
Other outcomes:
Locations:
Study officials:
References: