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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Constitutional Thinness

Treatments: Behavioral: Compensatory Nutrition (NC); Other: Adapted Physical Activity (APA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06894043

ANSM (Other Identifier)

24CH263

Details and patient eligibility

About

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).

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

APA + NC

Experimental group

Treatment:

Other: Adapted Physical Activity (APA)

Behavioral: Compensatory Nutrition (NC)

Control

No Intervention group

Description:

* 2-week run-in period * Followed by an 8-week period of conventional management without APA and without NC