Clinical Trial in Constitutional Thinness
Not Applicable
Completed
- Conditions
- Individuals With Constitutional Thinness
- Interventions
- 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.
- Registration Number
- NCT02004821
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renutryl® Booster 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. Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat).
- Primary Outcome Measures
Name Time Method 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 6 weeks Molecular analyses of plasma, fat and muscle biopsies and urine
- Secondary Outcome Measures
Name Time Method Metabolic, anthropometric, histological, and microbiome differences between a group of CT subjects and a control group before, during, and after 14 days of overnutrition 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
Trial Locations
- Locations (1)
CHU de Saint-Étienne
🇫🇷St-Etienne, France