Polyphenols and Insulin Resistance (POLYOXRESIST)

February 10, 2012 updated by: University Hospital, Montpellier

INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE

Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

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

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

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

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
  • Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT < 3 times the normal value and serum creatinine <150 micromol/l).
  • Age between 30 and 55 years.
  • Fasting plasma glucose <110 mg/dl and absence of any anti-diabetic treatment
  • No regular physical activity (Voorips index < 9)
  • Absence of any drug treatment in progress and during the last 2 months
  • Subjects with at least one 1st degree relative with T2D and with a body mass index between 25 and 35 kg/m² and a waist measurement >94 cm for males, and >80 cm for females.
  • Normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l).
  • Normal ferritin level (75 - 300 ng/ml)
  • hs-CRP <8 mg/l.
  • Absence of arterial hypertension (systolic pressure <140 mmHg and diastolic pressure <90 mmHg).
  • Non smoker or former smoker (quit smoking >1 year).
  • Alcohol consumption <30 g/day.

Exclusion Criteria:

  • Hyperthermia (T°>38°c)
  • Subject deprived of freedom by a court or administrative order
  • Major protected by the law
  • Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
  • Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
  • Subject who cannot be subjected to muscle biopsy.
  • Allergy to the anaesthetic
  • Woman in age to procreate and not taking any oral or intra-uterine contraception

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyphenols
9 weeks of supplementation with polyphenols(D56) and during the last week supplementation with polyphenols associated with a fructose load during the last 6 days (D63).
Drug: polyphenol
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
Placebo Comparator: placebo
9 weeks of supplementation with placebo (D56) and during the last week supplementation with placebo associated with a fructose load during the last 6 days (D63).
Drug: placebo
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral insulin-sensitivity
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
biochemical parameters
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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

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

October 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 13, 2012

Last Update Submitted That Met QC Criteria

February 10, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF8178

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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