Polyphenols and Overfeeding

NCT02145780 | Completed

• 1 other identifier: 2013-807
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Peripheral insulin sensitivity

  Volunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.

  During 31 days

Secondary Outcomes (6)

• Hepatic insulin sensitivity

  before and after the 31 days of overfeeding

• Change in genes expression in adipose and muscle tissues

  Before and after the 31 days of overfeeding

• Anthropometry, Fat quantification and Abdominal fat distribution

  During 31 days

• Fasting and Postprandial partitioning of exogenous lipid

  Fasting and during all the postprandial period (0-300 minutes)

• Modification in intestinal microbiota

  Before and after the 31 days of overfeeding

Study Arms (2)

2g of grape polyphenol extract supplement

EXPERIMENTAL

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

Dietary Supplement: 2g of grape polyphenol extract

2g of placebo (lactose)

PLACEBO COMPARATOR

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

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

Interventions

2g of grape polyphenol extract DIETARY_SUPPLEMENT

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

2g of grape polyphenol extract supplement

Dietary Supplement: 2g of placebo (lactose) DIETARY_SUPPLEMENT

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

2g of placebo (lactose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)

Pierre-Bénite, 69495, France

Location

Related Publications (2)

• 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.

  PMID: 36386937 DERIVED

• 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.

  PMID: 35614978 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Dietary Supplements; Lactose

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Martine LAVILLE, MD, PhD

  Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 23, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

FR (1)