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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenugreek seed | Experimental | 500 mg of fenugreek seed before each meal for 12 weeks |
|
| Placebo | Placebo Comparator | 500 mg of calcined magnesia before each meal for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenugreek seed | Dietary Supplement | Fenugreek seed: 1500 mg per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight (BW) | Body Weight (BW) is evaluated at baseline and after 12 weeks with an inbody 270 | 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 |
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Inclusion 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.
Non-Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marisol Cortez Navarrete, PhD | Contact | (33) 1058-5200 | 34211 | marisol.cortez@academicos.udg.mx |
| Name | Affiliation | Role |
|---|---|---|
| Marisol Cortez Navarrete, PhD | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de TerapĂ©utica Experimental y ClĂnica (INTEC), Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara. | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C056164 | fenugreek seed meal |
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A randomized, double-blind, placebo-controlled clinical trial
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| Placebo | Other | Placebo: Calcined magnesia 1500 mg per day for 12 weeks |
|
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| 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) |
| 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 | 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 | 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 | 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 | 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 | 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 | Baseline to week 12 (end of intervention) |
| Creatinine | Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques | 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 | 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 | Baseline to week 12 (end of intervention) |