About this trial
Constitutional Thinness (CT) is a form of stable thinness without malnutrition but with resistance to weight gain, affecting approximately 1% of the general population. The clinical consequences are numerous and the pathophysiology remains poorly understood.
Currently, conventional management involves a high-calorie and frequent diet, combined with the avoidance of endurance physical activity, although there is no significant evidence of its effectiveness.
Our hypothesis is that an adapted physical activity program (APA) combined with compensatory nutrition (CN) could help these patients gain lean mass (muscle mass).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gender: Female
BMI: ≤ 18.5 kg/m²
Weight Stability: Stable weight for at least 3 months
Age: 18 to 50 years old at the inclusion visit
Disqualifiers
Pregnancy, Parturition, or Lactation
Legal Restrictions: Individuals deprived of liberty, involuntarily hospitalized, or hospitalized for reasons other than research purposes, adults under legal protection (guardianship or curatorship) or unable to provide consent
Eating Disorders: Individuals with eating disorders (DSM IV and 5 criteria)
Excessive Alcohol Consumption: Consumption exceeding the equivalent of 10 glasses of wine per week
Trial design
Parallel
Treatments tested in this trial
Adapted Physical Activity (APA)
Other interventionThe APA intervention will consist of a 2-week running-in period, followed by a period of adapted physical activity (APA) for 8 weeks.
Compensatory Nutrition (NC)
BehavioralThe Compensatory Nutrition (NC) intervention will consist of a 2-week running-in period, followed by a period of compensated nutrition (NC) for 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Lean body mass
Lean body mass gain (kg) measured by bioimpedance
Secondary outcomes
BMI
Body masse index : ratio between weight and height
Energy balance
Ratio between calorie intake and calorie expenditure Caloric intake measured by dietary records over 2 weeks (calorie); Calorie expenditure: Resting metabolism measured by indirect calorimetry (kcal/24h); + Postprandial thermogenesis measured by indirect calorimetry (kcal/24h);; + Physical activity energy expenditure measured by connected watch (kcal/24h);
Physical exercise capacity
Changes in VO2max
Quality of life SF-12 questionnaire
SF-12 questionnaire; Self-measurement questionnaire SF-12 (Short Form Health Survey 12); comprising 12 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite);
Sponsors and contacts
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Centre Hospitalier Universitaire de Saint Etienne
Lead sponsor
Laboratoire Interuniversitaire de Biologie de la Motricité
Collaborator
Target Tape
Collaborator