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Polyphenols and Overfeeding

NCT02145780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-08-23

No results posted yet for this study

Summary

Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. The model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human.

The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal.

During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.

Conditions

  • Overfeeding

Interventions

DIETARY_SUPPLEMENT

2g of grape polyphenol extract

Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.

DIETARY_SUPPLEMENT

Dietary Supplement: 2g of placebo (lactose)

Men will have to consume daily 2g of placebo during the 31 days of overfeeding.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Martine LAVILLE, MD, PhD · Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • France

Study Locations

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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 NCT02145780 on ClinicalTrials.gov