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

NCT07056712 | Not Yet Recruiting

• 1 other identifier: Fenugreek-MS
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Fenugreek; Insulin Secretion; Insulin Sensitivity; Nutraceutic

Outcome Measures

Primary Outcomes (9)

• Waist Circumference (WC)

  Waist Circumference (WC) is evaluated at baseline and after 12 weeks with a flexible tape in the midpoint between the lowest rib and the iliac crest

  Baseline to week 12 (end of intervention)

• Systolic Blood Pressure (SBP)

  Systolic Blood Pressure (SBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer

  Baseline to week 12 (end of intervention)

• Diastolic Blood Pressure (DBP)

  Diastolic Blood Pressure (DBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer

  Baseline to week 12 (end of intervention)

• High Density Lipoprotein Cholesterol (HDL-c)

  High Density Lipoprotein Cholestero (HDL-c) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques

  Baseline to week 12 (end of intervention)

• Triglycerides (TG)

  Triglycerides (TG) are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques

  Baseline to week 12 (end of intervention)

• Fasting Plasma Glucose (FPG)

  Fasting Plasma Glucose (FPG) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques

  Baseline to week 12 (end of intervention)

• Insulin Sensitivity (IS)

  Insulin Sensitivity (IS) will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity

  Baseline to week 12 (end of intervention)

• Total Insulin Secretion (TIS)

  Total Insulin Secretion (TIS) will be calculated at baseline and week 12. It is the result of the ratio between the AUC of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT. It allows estimating the proportion of total insulin secretion in relation to plasma glucose concentration.

  Baseline to week 12 (end of intervention)

• First Phase of Insulin Secretion (FPIS)

  The First Phase if Insulin Secretion (FPIS) will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion

  Baseline to week 12 (end of intervention)

Secondary Outcomes (11)

• Body Weight (BW)

  Baseline to week 12 (end of intervention)

• Body Mass Index (BMI)

  Baseline to week 12 (end of intervention)

• Body Fat Percentage (BF%)

  Baseline to week 12 (end of intervention)

• Total Cholesterol (TC)

  Baseline to week 12 (end of intervention)

• Low Density Lipoprotein Cholesterol (LDL-c)

  Baseline to week 12 (end of intervention)

Study Arms (2)

Fenugreek seed

EXPERIMENTAL

500 mg of fenugreek seed before each meal for 12 weeks

Dietary Supplement: Fenugreek seed

Placebo

PLACEBO COMPARATOR

500 mg of calcined magnesia before each meal for 12 weeks

Other: Placebo

Interventions

Fenugreek seed DIETARY_SUPPLEMENT

Fenugreek seed: 1500 mg per day for 12 weeks

Also known as: Trigonella foenum-graecum

Fenugreek seed

Placebo OTHER

Placebo: Calcined magnesia 1500 mg per day for 12 weeks

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

fenugreek seed meal

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marisol Cortez Navarrete, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisol Cortez Navarrete, PhD

CONTACT

(33) 1058-5200; marisol.cortez@academicos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-06

Locations

ME (1)