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Polyphenols and Insulin Resistance

NCT01478841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-02-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-07-31
Completion
2012-01-31

Countries

  • France

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478841 on ClinicalTrials.gov