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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adapted Physical Activity (APA)

    Other intervention

    The APA intervention will consist of a 2-week running-in period, followed by a period of adapted physical activity (APA) for 8 weeks.

  • Compensatory Nutrition (NC)

    Behavioral

    The Compensatory Nutrition (NC) intervention will consist of a 2-week running-in period, followed by a period of compensated nutrition (NC) for 8 weeks.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: APA + NCExperimental treatment 2 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Lean body mass

Lean body mass gain (kg) measured by bioimpedance

Time frame
From day 1 to week 8

Secondary outcomes

1

BMI

Body masse index : ratio between weight and height

Time frame
From day 1 to week 8
2

Energy balance

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);

Time frame
From day 1 to week 8
3

Physical exercise capacity

Changes in VO2max

Time frame
From day 1 to week 8
4

Quality of life SF-12 questionnaire

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);

Time frame
From day 1 to week 8

Other outcomes

Sponsors and contacts

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Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Laboratoire Interuniversitaire de Biologie de la Motricité

Collaborator

Target Tape

Collaborator