Study of the Mechanisms of Metabolic Adaptations to Overfeeding (Polynut)

March 5, 2016 updated by: Francois Pralong, Centre Hospitalier Universitaire Vaudois

Study of the Determinants and Mechanisms of Adaptation of Metabolic Responses to Controlled Overfeeding in Female and Male Healthy Volunteers

Obesity results from complex interactions between genetic and environmental factors, and are strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is defined as an excessive fat accumulation that presents a risk to health, a risk that is highly dependent upon the type of adipose tissue accumulation, whether visceral or sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory cells accumulation. Because of the well known sexual difference in fat accretion, this obesity-associated risk may also be very different for men and for women. In addition, recent data indicate that various factors such as the intestinal microbiota, but also the dietary intake of protective nutrients might be important determinants of the metabolic complications of obesity.

Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue accumulation during a period of controlled caloric over-nutrition, both in men and in women; 2) evaluate the potential protective effects of a supplementation with polyphenols on insulin resistance and other metabolic adaptations.

Study Overview

Detailed Description

To achieve these goals, healthy male and female volunteers will be enrolled into a one month longitudinal, prospective study on the influence of hypercaloric overfeeding (+50% of daily caloric needs) on different tissues (adipose tissue, muscle and blood).

They will be separated into two different groups: hypercaloric nutrition and placebo, and hypercaloric nutrition and polyphenols (2g/day), where polyphenols administration will be randomized and administered in a double blind fashion. Whole body and hepatic insulin sensitivity, total energy expenditure, glucose hepatic production, protein and gene expression in muscle, adipose tissue and blood as well as intestinal microbiota will be assessed at base line, and after one month of overfeeding.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • CHUVaudois
        • Contact:
          • Weilin Kong, MD
        • Principal Investigator:
          • Francois P Pralong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal healthy male and female volunteer

Exclusion Criteria:

  • Diabetes mellitus
  • High blood pressure
  • Liver disease
  • Kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypercaloric diet and polyphenols

polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.

Hypercaloric diet will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.

Hypercaloric diet will be designed to provide 50% excess in calories compared to daily requirements. It will consist in a "snack" type, high fat and high carbohydrates diet.
Other Names:
  • Overfeeding
Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.
Active Comparator: Hypercaloric diet and placebo

Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.

Overfeeding will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.

Hypercaloric diet will be designed to provide 50% excess in calories compared to daily requirements. It will consist in a "snack" type, high fat and high carbohydrates diet.
Other Names:
  • Overfeeding
Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in insulin sensitivity
Time Frame: baseline, day 31 of overfeeding
Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.
baseline, day 31 of overfeeding

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in muscle and adipose tissue gene expression
Time Frame: Baseline, day 28 of overfeeding
Transcriptomic experiments will be performed on muscle and adipose tissue samples
Baseline, day 28 of overfeeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Francois P Pralong, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 5, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 391/13
  • SNF 320030_141065 (Other Grant/Funding Number: Swiss National Science Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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