Clinical trial NCT02004821: Clinical Trial in Constitutional Thinness
Official title: Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuals With Constitutional Thinness
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 weeks
Secondary outcomes:
measure: Metabolic, anthropometric, histological, and microbiome differences between a group of CT subjects and a control group before, during, and after 14 days of overnutrition
timeFrame: 6 weeks
Other outcomes:
Locations:
city: St-Etienne
country: France
facility: CHU de Saint-Étienne
Study officials:
affiliation: CHU de Saint-Étienne
name: Bruno Estour, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cominetti O, Nunez Galindo A, Corthesy J, Carayol J, Germain N, Galusca B, Estour B, Hager J, Gheldof N, Dayon L. Proteomics reveals unique plasma signatures in constitutional thinness. Proteomics Clin Appl. 2022 Sep;16(5):e2100114. doi: 10.1002/prca.202100114. Epub 2022 May 26.
citation: Bailly M, Germain N, Feasson L, Costes F, Estour B, Hourde C, N Merlet A, Thomas T, Hager J, Pereira B, Thivel D, Courteix D, Galusca B, Verney J. Skeletal muscle of females and males with constitutional thinness: a low intramuscular lipid content and oxidative profile. Appl Physiol Nutr Metab. 2020 Nov;45(11):1287-1298. doi: 10.1139/apnm-2020-0068. Epub 2020 Jun 1.
citation: Ling Y, Galusca B, Martin FP, Bartova S, Carayol J, Moco S, Epelbaum J, Grouselle D, Boirie Y, Montaurier C, Cuenco J, Minnion JS, Thomas T, Mure S, Hager J, Estour B, Gheldof N, Germain N. Resistance to lean mass gain in constitutional thinness in free-living conditions is not overpassed by overfeeding. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1187-1199. doi: 10.1002/jcsm.12572. Epub 2020 Apr 10.
citation: Ling Y, Carayol J, Galusca B, Canto C, Montaurier C, Matone A, Vassallo I, Minehira K, Alexandre V, Cominetti O, Nunez Galindo A, Corthesy J, Dayon L, Charpagne A, Metairon S, Raymond F, Descombes P, Casteillo F, Peoc'h M, Palaghiu R, Feasson L, Boirie Y, Estour B, Hager J, Germain N, Gheldof N. Persistent low body weight in humans is associated with higher mitochondrial activity in white adipose tissue. Am J Clin Nutr. 2019 Sep 1;110(3):605-616. doi: 10.1093/ajcn/nqz144.