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Clinical Trial in Constitutional Thinness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02004821
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE November 15, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial in Constitutional Thinness
Official Title  ICMJE Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle
Brief Summary The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Individuals With Constitutional Thinness
Intervention  ICMJE 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.
Study Arms  ICMJE 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).
Intervention: 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.
Publications * Ling Y, Carayol J, Galusca B, Canto C, Montaurier C, Matone A, Vassallo I, Minehira K, Alexandre V, Cominetti O, Núñez Galindo A, Corthésy J, Dayon L, Charpagne A, Métairon S, Raymond F, Descombes P, Casteillo F, Peoc'h M, Palaghiu R, Féasson L, Boirie Y, Estour B, Hager J, Germain N, Gheldof N. Persistent low body weight in humans is associated with higher mitochondrial activity in white adipose tissue. Am J Clin Nutr. 2019 Sep 1;110(3):605-616. doi: 10.1093/ajcn/nqz144.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
70
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004821
Other Study ID Numbers  ICMJE 12.17.NIHS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruno Estour, Prof. CHU de Saint-Étienne
PRS Account Nestlé
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP