NCT06894043 Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
| NCT ID | NCT06894043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Constitutional Thinness |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-07-07 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06894043 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Constitutional Thinness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894043 currently recruiting?
Yes, NCT06894043 is actively recruiting participants. Contact the research team at natacha.germain@chu-st-etienne.fr for enrollment information.
Where is the NCT06894043 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT06894043 clinical trial?
NCT06894043 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 62 participants.