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Clinical Trials/NCT06894043
NCT06894043RecruitingNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country62 target enrollmentStarted: July 7, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
62
Locations
1
Primary Endpoint
Lean body mass
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

APA + NC

Experimental

Intervention: Adapted Physical Activity (APA) (Other)

APA + NC

Experimental

Intervention: Compensatory Nutrition (NC) (Behavioral)

Control

No Intervention
  • 2-week run-in period
  • Followed by an 8-week period of conventional management without APA and without NC

Outcomes

Primary Outcomes

Lean body mass

Time Frame: From day 1 to week 8

Lean body mass gain (kg) measured by bioimpedance

Secondary Outcomes

  • BMI(From day 1 to week 8)
  • Physical exercise capacity(From day 1 to week 8)
  • Energy balance(From day 1 to week 8)
  • Quality of life SF-12 questionnaire(From day 1 to week 8)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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