Polyphenols and Overfeeding (Poly-Nut)

Civil Hospices of Lyon

Status: Completed

Conditions: Overfeeding

Treatments: Dietary Supplement: 2g of grape polyphenol extract; Dietary Supplement: Dietary Supplement: 2g of placebo (lactose)

Study type: Interventional

Funder types: Other

Identifiers

NCT02145780

2013-807

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

2g of grape polyphenol extract supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: 2g of grape polyphenol extract

2g of placebo (lactose)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary Supplement: 2g of placebo (lactose)