Clinical Trials in Mexico / NCT07056712
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Effect of Fenugreek Seed Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
NCT07056712 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Metabolic Syndrome
Investigational drug(s) / intervention(s)
Fenugreek seedPlacebo
Fenugreek seed: Fenugreek seed: 1500 mg per day for 12 weeks
Placebo: Placebo: Calcined magnesia 1500 mg per day for 12 weeks
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Waist Circumference (WC) — Baseline to week 12 (end of intervention)
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 - Systolic Blood Pressure (SBP) — Baseline to week 12 (end of intervention)
Systolic Blood Pressure (SBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer - Diastolic Blood Pressure (DBP) — Baseline to week 12 (end of intervention)
Diastolic Blood Pressure (DBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer - High Density Lipoprotein Cholesterol (HDL-c) — Baseline to week 12 (end of intervention)
High Density Lipoprotein Cholestero (HDL-c) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques - Triglycerides (TG) — Baseline to week 12 (end of intervention)
Triglycerides (TG) are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques - Fasting Plasma Glucose (FPG) — Baseline to week 12 (end of intervention)
Fasting Plasma Glucose (FPG) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques - Insulin Sensitivity (IS) — Baseline to week 12 (end of intervention)
Insulin Sensitivity (IS) will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity - Total Insulin Secretion (TIS) — Baseline to week 12 (end of intervention)
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. - First Phase of Insulin Secretion (FPIS) — Baseline to week 12 (end of intervention)
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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Instituto de Terapéutica Experimental y Clínica (INTEC), Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara. | Guadalajara | Jalisco |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07056712 on ClinicalTrials.gov ↗ ← All trials in Mexico