Adapted exercise plus targeted nutrition to help women with constitutional thinness gain muscle
Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
This trial will test whether a tailored physical activity program combined with compensatory nutrition helps adult women with constitutional thinness gain lean (muscle) mass.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne, France) |
| Trial ID | NCT06894043 on ClinicalTrials.gov |
What this trial studies
Constitutional thinness is a stable form of low body weight without malnutrition and is resistant to conventional high-calorie approaches. This interventional program combines adapted physical activity (focused on resistance-type training) with compensatory nutritional support to promote lean mass gain. Adult women meeting strict inclusion criteria (BMI ≤ 18.5, age 18–50, stable weight) will follow the combined program at the coordinating center, with muscle mass and related outcomes monitored over the intervention period. The protocol aims to provide structured exercise sessions alongside nutrition strategies tailored to counteract resistance to weight and muscle gain.
Who should consider this trial
Good fit: Adult women aged 18–50 with a diagnosis of constitutional thinness, BMI ≤ 18.5 kg/m², and stable weight for at least 3 months who are not pregnant and have no eating disorder or severe progressive illness.
Not a fit: People who are pregnant or lactating, have eating disorders or severe progressive diseases, engage in intense regular physical activity, are heavy smokers, or are under legal/psychiatric restrictions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could increase lean (muscle) mass, improve strength and physical resilience, and offer a more evidence-based management option for affected women.
How similar studies have performed: Combined resistance exercise and nutritional supplementation have shown benefits in other underweight or muscle-loss conditions, but applying this specific approach to constitutional thinness is relatively novel and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint-Etienne, France
- CHU de Saint-Etienne — Saint-Etienne, France, France (Recruiting)
Study contacts
- Study coordinator: Natacha GERMAIN, PhD
- Email: natacha.germain@chu-st-etienne.fr
- Phone: (0)477120621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.