Individuals With Constitutional Thinness Clinical Trial
Official title:
Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle
The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | May 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 35 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Saint-Étienne | St-Etienne |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |