Trial record 7 of 81 for:    resveratrol

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: NA
Last verified: April 2014
History: No changes posted
  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:
  • Change from baseline of waist circumference at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The waist circumference is going to be evaluated at baseline and week 12 with a flexible tape with standardized techniques. Differences will be calculated.

  • Change from baseline of triglycerides levels at week 12 [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The triglycerides levels are going to be evaluated at baseline and week 12 with enzymatic-colorimetric techniques. Differences will be calculated.

  • Change from baseline of high density lipoprotein (c-HDL) levels at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The c-HDL levels are going to be evaluated at baseline and week 12 with enzymatic/colorimetric techniques. Differences will be calculated.

  • Change from baseline of fasting glucose levels at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The fasting glucose levels are going to be evaluated at baseline and week 12 with enzymatic/colorimetric techniques. Differences will be calculated.

  • Change from baseline of blood pressure at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The blood pressure is going to be evaluated at baseline and week 12 with a digital sphygmomanometer. Differences will be calculated.

  • Change from baseline of first phase of insulin secretion at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The first phase of insulin secretion is going to be calculated at baseline and week 12 with Stumvoll index. Differences will be calculated.

  • Change from baseline of total insulin secretion at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The total insulin secretion is going to be calculated at baseline and week 12 with insulinogenic index. Differences will be calculated.

  • Change from baseline of total insulin sensitivity at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The insulin sensitivity is going to be calculated at baseline and week 12 with Matsuda index. Differences will be calculated.


Secondary Outcome Measures:
  • Change from baseline of weight at week 12. [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The weight it's going to be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance. Differences will be calculated

  • Change from baseline of Body Mass Index at week 12 [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The Body Mass index it's going to be calculated at baseline and at week 12 with the Quetelet index. Differences will be calculated.

  • Change from baseline of total cholesterol at week 12 [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The total cholesterol will be estimated by standardized techniques at baseline and week 12. Differences will be calculated.

  • Change from baseline of low density lipoproteins (c-LDL) at week 12 [ Time Frame: Baseline. Week 12 ] [ Designated as safety issue: No ]
    The c-LDL levels are going to be measured at baseline and at week 12 with standardized techniques.

  • Change from baseline of hepatic transaminases at week 12. [ Time Frame: Baseline. Week 12. ] [ Designated as safety issue: No ]
    The hepatic transaminases levels are going to be measured at baseline and at week 12 with standardized techniques.

  • Change from baseline of creatinine at week 12. [ Time Frame: Baseline. Week 12. ] [ Designated as safety issue: No ]
    The creatinine levels are going to be measured at baseline and at week 12 with standardized techniques.

  • Change from baseline of uric acid at week 12. [ Time Frame: Baseline. Week 12. ] [ Designated as safety issue: No ]
    The uric acid levels are going to be measured at baseline and at week 12 with standardized techniques.


Enrollment: 21
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
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
Last Updated: April 11, 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
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Magnesium Oxide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents

ClinicalTrials.gov processed this record on July 24, 2014