The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome

NCT06114134 | Unknown

• 1 other identifier: 97-1151
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome; Complementary Therapies; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Lipid profile

  baseline and 2 months

• Lipid profile

  baseline and 2 months

• Lipid profile

  baseline and 2 months

• Lipid profile

  baseline and 2 months

• Antropometric Indices

  baseline and 2 months

Study Arms (2)

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

Dietary Supplement: Fenobet

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

Dietary Supplement: Placebo

Interventions

Fenobet DIETARY_SUPPLEMENT

receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)

Fenugreek extract

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People with metabolic syndrome
• Fasting sugar above 100 mg/dL
• Both men and women
• Age range 20-60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: February 20, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share