Effect of Fenugreek Seed Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

NCT ID: NCT07056712

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-09-15

Brief Summary

Fenugreek has been shown to have beneficial effects on various metabolic abnormalities associated with metabolic syndrome (MS). However, no clinical trials have evaluated its effect on all components of MS, insulin sensitivity, and insulin secretion. Therefore, the main objective of this study is to assess the effect of fenugreek seed administration versus placebo on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.

Detailed Description

A randomized, double-blind, placebo controlled clinical trial will be conducted in 28 patients with metabolic syndrome according to the criteria of the International Diabetes Federation. Patients will be assigned to two different arms: one group will receive fenugreek seed extract (1500 mg/day) or a matched placebo for 12 weeks.

At the beginning and end of the intervention, the following measurements will be taken: body weight, body mass index, waist circumference, body fat percentage, systolic blood pressure, diastolic blood pressure, glucose, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein, insulin, creatinine, uric acid, alanine aminotransferase, and aspartate aminotransferase. In addition, insulin sensitivity and insulin secretion will be calculated. Written informed consent will be obtained from all volunteers.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fenugreek seed

500 mg of fenugreek seed before each meal for 12 weeks

Group Type: EXPERIMENTAL

Fenugreek seed

Intervention Type: DIETARY_SUPPLEMENT

Fenugreek seed: 1500 mg per day for 12 weeks

Placebo

500 mg of calcined magnesia before each meal for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo: Calcined magnesia 1500 mg per day for 12 weeks

Interventions

Fenugreek seed

Fenugreek seed: 1500 mg per day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo: Calcined magnesia 1500 mg per day for 12 weeks

Intervention Type: OTHER

Other Intervention Names

Trigonella foenum-graecum; Calcined magnesia

Eligibility Criteria

Inclusion Criteria

• Men and women between 30 and 60 years old.
• Diagnosis of Metabolic Syndrome (MS) according to the International Diabetes Federation (IDF) criteria.

Waist circumference ≥90 cm in men and ≥80 cm in women, plus the presence of two or more of the following criteria:

• Fasting glucose ≥100 mg/dL or previous diagnosis of type 2 diabetes.
• Systolic Blood Pressure ≥130 mmHg.
• Diastolic Blood Pressure ≥85 mmHg.
• Triglycerides ≥150 mg/dL.
• HDL cholesterol <40 mg/dL in men and <50 mg/dL in women.

• Body Mass Index between 25.0 and 34.9 kg/m².
• Stable weight during the 3 months prior to the start of the study (weight variation less than 10%).
• Not receiving pharmacological treatment for any component of MS, insulin sensitivity, and/or insulin secretion.
• Signed informed consent form.

• Suspected or confirmed pregnancy.
• Breastfeeding period.
• Fasting glucose ≥126 mg/dL.
• LDL cholesterol ≥155 mg/dL.
• Triglycerides ≥500 mg/dL.
• Systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg.
• Use of medications and/or supplements known to influence the study variables.
• History of kidney, thyroid, liver disease, or ischemic heart disease.
• Active smoker.
• Not using an effective and stable contraceptive method.

Exclusion Criteria

• Voluntary withdrawal of informed consent.
• Treatment adherence ≤80%.
• Occurrence of a serious adverse event.
• Loss to follow-up.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Marisol Cortez Navarrete

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marisol Cortez Navarrete, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Locations

Instituto de Terapéutica Experimental y Clínica (INTEC), Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara.

Guadalajara, Jalisco, Mexico

Countries

Mexico

Central Contacts

Marisol Cortez Navarrete, PhD

Role: CONTACT

marisol.cortez@academicos.udg.mx

(33) 1058-5200 ext. 34211

Facility Contacts

Marisol Cortez Navarrete, PhD

Role: primary

marisol.cortez@academicos.udg.mx

3310585200 ext. 34211

Karina G Pérez Rubio, PhD

Role: backup

karina.prubio@academicos.udg.mx

3310585200 ext. 34212

Other Identifiers

Fenugreek-MS

Identifier Type: -

Identifier Source: org_study_id