Clinical trial NCT02145780: Polyphenols and Overfeeding
Official title: Polyphenols: Protection From Overfeeding-induced Insulin Resistance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overfeeding
Keywords: Overfeeding
Fat distribution
Subcutaneous and visceral adipose tissue
Insulin sensitivity
Insulin resistance
Peripheral and hepatic insulin sensitivity
Stable isotopes
Lipid oxidation
Energy expenditure
Muscle and subcutaneous adipose tissue gene expression
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peripheral insulin sensitivity
timeFrame: During 31 days
Secondary outcomes:
measure: Hepatic insulin sensitivity
timeFrame: before and after the 31 days of overfeeding
measure: Change in genes expression in adipose and muscle tissues
timeFrame: Before and after the 31 days of overfeeding
measure: Anthropometry, Fat quantification and Abdominal fat distribution
timeFrame: During 31 days
measure: Fasting and Postprandial partitioning of exogenous lipid
timeFrame: Fasting and during all the postprandial period (0-300 minutes)
measure: Modification in intestinal microbiota
timeFrame: Before and after the 31 days of overfeeding
measure: Energy expenditure and substrate oxidation with indirect calorimetry
timeFrame: Fasting and during all the postprandial period (0-300 minutes)
Other outcomes:
Locations:
city: Pierre-bénite
country: France
facility: Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
Study officials:
affiliation: Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
name: Martine LAVILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartova S, Madrid-Gambin F, Fernandez L, Carayol J, Meugnier E, Segrestin B, Delage P, Vionnet N, Boizot A, Laville M, Vidal H, Marco S, Hager J, Moco S. Grape polyphenols decrease circulating branched chain amino acids in overfed adults. Front Nutr. 2022 Oct 26;9:998044. doi: 10.3389/fnut.2022.998044. eCollection 2022.
citation: Segrestin B, Delage P, Nemeth A, Seyssel K, Disse E, Nazare JA, Lambert-Porcheron S, Meiller L, Sauvinet V, Chanon S, Simon C, Ratiney H, Beuf O, Pralong F, Yassin NA, Boizot A, Gachet M, Burton-Pimentel KJ, Vidal H, Meugnier E, Vionnet N, Laville M. Polyphenol Supplementation Did Not Affect Insulin Sensitivity and Fat Deposition During One-Month Overfeeding in Randomized Placebo-Controlled Trials in Men and in Women. Front Nutr. 2022 May 9;9:854255. doi: 10.3389/fnut.2022.854255. eCollection 2022.