An interventional study of Fenugreek seed and Placebo in Metabolic Syndrome, sponsored by University of Guadalajara. Not yet recruiting at 1 site in Mexico. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by University of Guadalajara · Not applicable, Interventional, and Treatment
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.
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 28 is below the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Guadalajara is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Waist circumference ≥90 cm in men and ≥80 cm in women, plus the presence of two or more of the following criteria:
HDL cholesterol \<40 mg/dL in men and \<50 mg/dL in women.
Non-Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500 mg of fenugreek seed before each meal for 12 weeks
Dietary Supplement: Fenugreek seed
500 mg of calcined magnesia before each meal for 12 weeks
Other: Placebo
Fenugreek seed: 1500 mg per day for 12 weeks
Also known as: Trigonella foenum-graecum
Placebo: Calcined magnesia 1500 mg per day for 12 weeks
Also known as: Calcined magnesia
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to week 12 (end of intervention)
Triglycerides (TG)
Triglycerides (TG) are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline to week 12 (end of intervention)
Body Weight (BW)
Body Weight (BW) is evaluated at baseline and after 12 weeks with an inbody 270
Time frame: Baseline to week 12 (end of intervention)
Body Mass Index (BMI)
Body Mass Index (BMI) is calculated at baseline and after 12 weeks with the Quetelet index formula
Time frame: Baseline to week 12 (end of intervention)
Body Fat Percentage (BF%)
Body Fat Percentage (BF%) will be measured at baseline and week 12 with a bioimpedance analysis
Time frame: Baseline to week 12 (end of intervention)
Total Cholesterol (TC)
Total Cholesterol (TC) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: Baseline to week 12 (end of intervention)
Low Density Lipoprotein Cholesterol (LDL-c)
Low Density Lipoprotein Cholesterol (LDL-c) level will be calculated at baseline and week 12 with Friedewald formula to get LDL-c level
Time frame: Baseline to week 12 (end of intervention)
Very Low Density Lipoprotein (VLDL)
Very Low Density Lipoprotein (VLDL) is calculated at baseline and after 12 weeks as triglycerides/5
Time frame: Baseline to week 12 (end of intervention)
Aspartate Aminotransferase (AST)
Aspartate Aminotransferase (AST) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: Baseline to week 12 (end of intervention)
Alanine Aminotransferase (ALT)
Alanine Aminotransferase (ALT) is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: Baseline to week 12 (end of intervention)
Creatinine
Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: Baseline to week 12 (end of intervention)
Uric Acid (UA)
Uric Acid (UA) is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques
Time frame: Baseline to week 12 (end of intervention)
Adverse Events (AE)
Adverse Events (AE) of fenugreek seed or placebo will be identified by clinical evaluation from baseline week to week 12 with continuous surveillance
Time frame: Baseline to week 12 (end of intervention)
Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fenugreek seed meal
University of Guadalajara