drugset / Trial / NCT01478841

Polyphenols and Insulin Resistance

NCT01478841 ↗

Completed 44 enrolled University Hospital, Montpellier
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

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

Outcome

Met primary endpoint

paper All the deleterious effects of fructose were fully blunted by grape PP supplementation. PMID 23275372 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject grape polyphenols Unknown 2 g —