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Search / Trial NCT07056712

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

Launched by UNIVERSITY OF GUADALAJARA · Jun 29, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Metabolic Syndrome Fenugreek Insulin Secretion Insulin Sensitivity Nutraceutic

ClinConnect Summary

This clinical trial is looking at whether taking fenugreek seeds can help improve health problems related to metabolic syndrome, a condition that includes things like high blood pressure, high blood sugar, extra belly fat, and unhealthy cholesterol levels. The study will compare people who take fenugreek seeds with those who take a placebo (a harmless pill with no active ingredient) to see if fenugreek can improve these health measures, as well as how well the body uses and produces insulin, which is important for controlling blood sugar.

People eligible for this study are men and women aged 30 to 60 who have metabolic syndrome, defined by specific criteria like having a larger waist size plus at least two other issues such as high blood sugar, high blood pressure, or unhealthy cholesterol levels. Participants should have a stable weight and not be taking any medications for these conditions. If you join the study, you will be asked to take fenugreek seeds or a placebo and have your health monitored to see any changes. Important to know is that the study has strict rules about who can join, excluding people with certain health problems, those who smoke, or women who are pregnant or breastfeeding. This study is not yet recruiting participants.

Gender

ALL

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.
  • Non-Inclusion Criteria:
  • 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.

About University Of Guadalajara

The University of Guadalajara, a prominent academic institution in Mexico, is dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. With a commitment to scientific excellence and ethical standards, the university collaborates with various stakeholders to conduct rigorous studies aimed at addressing critical health challenges. Its multidisciplinary approach harnesses the expertise of faculty and researchers across diverse fields, fostering a robust environment for the development of groundbreaking treatments and interventions. By actively contributing to the global body of medical knowledge, the University of Guadalajara plays a vital role in enhancing patient care and promoting public health initiatives.

Locations

Guadalajara, Jalisco, Mexico

Patients applied

0 patients applied

Trial Officials

Marisol Cortez Navarrete, PhD

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported