Clinical Trial in Constitutional Thinness

September 27, 2016 updated by: Nestlé

Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle

The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • France
      • St-Etienne, France, 42055
        • CHU de Saint-Etienne

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

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria specific to subjects with constitutional thinness
  • Women: BMI less or equal to 17.5
  • Men: BMI less or equal to 18.5
  • Stable weight for at least 3 months

Inclusion criteria specific to subjects with normal weight

  • Men and women: BMI above or equal to 20 but not more than 25
  • Stable weight for at least 3 months
  • No previous family history of first or second-degree obesity

Inclusion criteria common to both groups

  • Age: between 18 and 35 at the inclusion visit
  • Normal blood sugar, liver function, lipid and coagulation profiles
  • Signed consent form to participate in the study
  • Signed consent form for genetic analysis
  • Acceptance of a moderate weight gain of 2 kg (less than 10% of body weight)
  • Beneficiary or member of a social security system.

Exclusion Criteria:

  • Adults with a legal guardian, or subjects unable to act freely due to a decision by a legal or administrative authority,
  • Pregnancy in the case of women
  • Women without contraception
  • Vegetarian subjects or those with lactose intolerance
  • Subjects with an eating disorder (DSM IV)
  • Significant alcohol consumption equivalent to more than 10 glasses of wine per week
  • Severe progressive disorder (diabetes, for example)
  • Subjects who undertake intensive physical activity (more than 3 sessions of physical activity per week)
  • Significant tobacco consumption equivalent to more than 10 cigarettes per day
  • Depression or psychiatric condition (treated with antidepressant or psychotropic medication), depression questionnaire/score
  • Medical or surgical history considered by the investigator to be incompatible with this study (stomach or intestinal surgery, for example)
  • Subjects receiving treatment that may interfere with the parameters measured: antihypertensives (blockers, centrally acting antihypertensives), anti-hyperlipidemic agents or corticosteroids for more than 8 days
  • Inclusion in a different clinical study within the previous 12 weeks.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renutryl® Booster
Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat).
Dietary supplement: Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular differences (evaluated in plasma, fat and muscle biopsies, urines) between a group of CT subjects and a control group before, during and after 14 days of overnutrition
Time Frame: 6 weeks
Molecular analyses of plasma, fat and muscle biopsies and urine
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic, anthropometric, histological, and microbiome differences between a group of CT subjects and a control group before, during, and after 14 days of overnutrition
Time Frame: 6 weeks
  • Metabolic differences (eg: lipids, amino-acids… in plasma and urine)
  • Anthropometric differences (eg: weight, BMI, waist/ hip ratio)
  • Histological (eg: muscle and fat tissue biopsies)
  • Inflammation and metabolism specific marker differences
  • Energy metabolism differences (eg: RER, RQ, Cox, Lox…)
  • Bone quality differences (eg: bone mineral density)
  • Microbiome differences
6 weeks

Collaborators and Investigators

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

Sponsor

Nestlé

Investigators

  • Principal Investigator: Bruno Estour, Prof., CHU de Saint-Etienne

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.

General Publications

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 (Actual)

March 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.17.NIHS

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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