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

August 28, 2020 updated by: Manuel González Ortiz, University of Guadalajara

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45037
        • Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol
Resveratrol capsules, 500 mg, three times per day before meals during 90 days
Drug: Resveratrol
Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.
Other Names:
  • Trans resveratrol
  • 3, 5, 4' -trihidroxiestilbeno
Placebo Comparator: Placebo
Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days
Drug: Placebo
Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Other Names:
  • Calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure at Week 12.
Time Frame: 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
Diastolic Blood Pressure at Week 12
Time Frame: 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
Triglycerides Levels at Week 12
Time Frame: 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.
Time Frame: Baseline. 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.
Time Frame: 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
First Phase of Insulin Secretion at Week 12.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index at Week 12
Time Frame: 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
Time Frame: 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
Weight at Week 12.
Time Frame: 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
Low Density Lipoproteins (c-LDL) at Week 12
Time Frame: 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.
Time Frame: Baseline. 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.
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESV-MS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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