Clinical trial NCT06894043: Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
Official title: Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Constitutional Thinness
Keywords: Constitutional thinness (CT)
Adapted Physical Activity
Compensatory nutrition
Lean and muscle mass gain
Resistance to gain weight
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Laboratoire Interuniversitaire de Biologie de la Motricité
name: Target Tape
First posted: 2025-03-25
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Lean body mass
timeFrame: From day 1 to week 8
Secondary outcomes:
measure: BMI
timeFrame: From day 1 to week 8
measure: Energy balance
timeFrame: From day 1 to week 8
measure: Physical exercise capacity
timeFrame: From day 1 to week 8
measure: Quality of life SF-12 questionnaire
timeFrame: From day 1 to week 8
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
References: