Individuals With Constitutional Thinness
Conditions
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.
Interventions
DIETARY_SUPPLEMENTRenutryl® 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.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed