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Completed

NCT Number: NCT02145780

Polyphenols and Overfeeding

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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Key information

Conditions

Overfeeding Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2g of grape polyphenol extract

Dietary Supplement

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

Dietary Supplement: 2g of placebo (lactose)

Dietary Supplement

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

Primary outcomes

  1. Peripheral insulin sensitivity

    Time frame: During 31 days

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

Secondary outcomes

  1. Hepatic insulin sensitivity

    Time frame: before and after the 31 days of overfeeding

    Endogenous glucose production (EGP) will be determined during the last 30 minutes of the low-dose insulin infusion.

  2. Change in genes expression in adipose and muscle tissues

    Time frame: Before and after the 31 days of overfeeding

    RT-PCR

  3. Anthropometry, Fat quantification and Abdominal fat distribution

    Time frame: During 31 days

    Weight, height, waist and hip circumferences, fat mass using dual x-ray absorptiometry (DEXA) and abdominal fat distribution using resonance magnetic imaging (RMI).

  4. Fasting and Postprandial partitioning of exogenous lipid

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

    13C enrichment will be measured in blood samples and breath test during a test meal performed before and after the 31 days of overfeeding.

  5. Modification in intestinal microbiota

    Time frame: Before and after the 31 days of overfeeding

    Feces analyses

  6. Energy expenditure and substrate oxidation with indirect calorimetry

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

    Energy metabolism will be measured before and after the 31 days of overfeeding.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Polyphenols: Protection From Overfeeding-induced Insulin Resistance?

Acronym: Poly-Nut

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 23, 2014
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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