Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness

Not Applicable

Not yet recruiting

• Conditions: Constitutional Thinness

• Registration Number: NCT06894043
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• 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
• Diagnosed with Constitutional thinness

Exclusion Criteria

• 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
• Severe Progressive Conditions: Progressive severe conditions (e.g., diabetes)
• Intense Physical Activity: Individuals engaging in intense physical activity (> 3 sessions per week)
• Heavy Smoking: Significant smoking (>10 cigarettes per day)
• Psychiatric Conditions: Presence of depressive or psychiatric conditions requiring antidepressant or psychotropic treatment
• Medical or Surgical History: Medical or surgical history deemed incompatible with the study by the investigator
• MRI Contraindication: Individuals with contraindications to MRI will not undergo spectro-MRI analyses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lean body mass	From day 1 to week 8	Lean body mass gain (kg) measured by bioimpedance

Secondary Outcome Measures

Name	Time	Method
BMI	From day 1 to week 8	Body masse index : ratio between weight and height
Energy balance	From day 1 to week 8	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	From day 1 to week 8	Changes in VO2max
Quality of life SF-12 questionnaire	From day 1 to week 8	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);

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France