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.
