Clinical Trial in Constitutional Thinness

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

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

Conditions
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Individuals With Constitutional Thinness

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renutryl® Booster<br>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.<br> <br> |

What is the study measuring?
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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 | 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 | 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 |