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Completed

NCT Number: NCT02004821

Clinical Trial in Constitutional Thinness

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Étienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2013
Registry last updated
Sep 28, 2016

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.