Polyphenols and Overfeeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2g of grape polyphenol extract supplement

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

Group Type EXPERIMENTAL

2g of grape polyphenol extract

Intervention Type DIETARY_SUPPLEMENT

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

2g of placebo (lactose)

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

Group Type PLACEBO_COMPARATOR

Dietary Supplement: 2g of placebo (lactose)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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2g of grape polyphenol extract

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

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: 2g of placebo (lactose)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male
* Aged from 18 to 55 years
* Body Mass Index of 23 to 27 kg/m²
* Normal blood pressure
* Fasting glycemia \< 7 mmol/L
* CRPus \< 10mg/L
* Triglycerides ≤ 3mmol/L

Exclusion Criteria

* Medical or surgical history which may affect the results (renal -cardiovascular - hepatic- endocrine-inflammatory diseases)
* Subjects under treatment which may interfere with the measured parameters
* Eating disorder
* Intensive sportive activity
* Dairy products allergy or intolerance

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes