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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara
ClinicalTrials.gov Identifier:
NCT02114892
First received: April 11, 2014
Last updated: December 16, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome X
Drug: Resveratrol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Resource links provided by NLM:


Further study details as provided by University of Guadalajara:

Primary Outcome Measures:
  • Triglycerides Levels at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12

  • High Density Lipoprotein (c-HDL) Levels at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Fasting Glucose Levels at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Systolic Blood Pressure at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • First Phase of Insulin Secretion at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Total Insulin Secretion at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Total Insulin Sensitivity at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12

  • Waist Circumference at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Diastolic Blood Pressure at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Weight at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Body Mass Index at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Total Cholesterol at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Low Density Lipoproteins (c-LDL) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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

  • Creatinine at Week 12. [ Time Frame: Baseline. Week 12. ] [ Designated as safety issue: No ]
    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

  • Uric Acid at Week 12. [ Time Frame: Week 12. ] [ Designated as safety issue: No ]
    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


Enrollment: 24
Study Start Date: April 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Calcined magnesia

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114892

Locations
Mexico
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 45037
Sponsors and Collaborators
University of Guadalajara
Investigators
Principal Investigator: MANUEL GONZALEZ, PhD University of Guadalajara
  More Information

Additional Information:
Publications:

Responsible Party: Manuel González Ortiz, Senior Researcher, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02114892     History of Changes
Other Study ID Numbers: RESV-MS 
Study First Received: April 11, 2014
Results First Received: December 2, 2014
Last Updated: December 16, 2014
Health Authority: Mexico: Local Committee of University of Guadalajara

Keywords provided by University of Guadalajara:
metabolic syndrome
central obesity
resveratrol
insulin secretion
insulin sensitivity

Additional relevant MeSH terms:
Resveratrol
Syndrome
Metabolic Syndrome X
Hypersensitivity
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Magnesium Oxide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016