Trial record 1 of 2 for:    Open Studies | "Thinness"
Previous Study | Return to List | Next Study

Clinical Trial in Constitutional Thinness

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT02004821
First received: November 15, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Individuals With Constitutional Thinness
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 Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Molecular analyses of plasma, fat and muscle biopsies and urine


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 70
Study Start Date: December 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004821

Contacts
Contact: Bruno Estour, Prof. 0033 4 77 12 77 27 bruno.estour@chu-st-etienne.fr
Contact: Natacha Germain, Prof. 0033 4 77 12 77 27 natacha.germain@chu-st-etienne.fr

Locations
France
CHU de Saint-Étienne Recruiting
St-Etienne, France, 42055
Contact: Bruno Estour, Prof.    +33 4 77 12 77 27    bruno.estour@chu-st-etienne.fr   
Contact: Natacha Germain, Prof.    +33 4 77 12 77 27    natacha.germain@chu-st-etienne.fr   
Principal Investigator: Bruno Estour, Prof.         
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Bruno Estour, Prof. CHU de Saint-Étienne
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02004821     History of Changes
Other Study ID Numbers: 12.17.NIHS
Study First Received: November 15, 2013
Last Updated: June 4, 2014
Health Authority: France: ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé)

Additional relevant MeSH terms:
Thinness
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014