Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Study Overview
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Brief Summary
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The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight. The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed Description
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A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load. 12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months. The remaining 12 patients received placebo with the same prescription. Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index). This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers. Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Official Title
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Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Drug: Resveratrol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients both sexes Age between 30 and 50 years Metabolic Syndrome according to the IDF criteria Waist circumference Man ≥90 cm Woman ≥80 cm And two of the following criteria: High density lipoprotein Man ≤40 mg/dL Woman ≤50 mg/dL Fasting glucose ≥100 mg/dL Triglycerides ≥150 mg/dL Blood pressure ≥130/85 mmHg Informed consent signed Exclusion Criteria: Women with confirmed or suspected pregnancy Women under lactation and/or puerperium Hypersensibility to resveratrol Physical impossibility for taking pills Known uncontrolled renal, hepatic, heart or thyroid diseased Previous treatment for the metabolic syndrome components Body Mass Index ≥39.9 kg/m2 Fasting glucose ≥126 mg/dL Triglycerides ≥500 mg/dL Total cholesterol ≥240 mg/dL Low density lipoprotein (c-LDL) ≥190 mg/dL Blood Pressure ≥140/90 mmHg

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol<br>Resveratrol capsules, 500 mg, three times per day before meals during 90 days | Drug: Resveratrol<br>* Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.<br>* Other names: 3, 5, 4' -trihidroxiestilbeno;|
| Placebo Comparator: Placebo<br>Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days | Drug: Placebo<br>* Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg<br>* Other names: Calcined magnesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides Levels at Week 12 | The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Week 12 | 
| High Density Lipoprotein (c-HDL) Levels at Week 12. | The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | Baseline. Week 12 | 
| Fasting Glucose Levels at Week 12. | The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Week 12 | 
| Systolic Blood Pressure at Week 12. | The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12 | Week 12 | 
| First Phase of Insulin Secretion at Week 12. | The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12 | Week 12 | 
| Total Insulin Secretion at Week 12. | The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12 | Week 12 | 
| Total Insulin Sensitivity at Week 12. | The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12 | Week 12 | 
| Waist Circumference at Week 12 | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12 | Week 12 | 
| Diastolic Blood Pressure at Week 12 | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight at Week 12. | The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | Week 12 | 
| Body Mass Index at Week 12 | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | Week 12 | 
| Total Cholesterol at Week 12 | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 | Week 12 | 
| Low Density Lipoproteins (c-LDL) at Week 12 | The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 | Week 12 | 
| Creatinine at Week 12. | The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12 | Baseline. Week 12. | 
| Uric Acid at Week 12. | The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12 | Week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, central obesity, resveratrol, insulin secretion, insulin sensitivity