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

NCT ID: NCT06894043

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Constitutional Thinness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APA + NC

Group Type EXPERIMENTAL

Adapted Physical Activity (APA)

Intervention Type OTHER

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)

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adapted Physical Activity (APA)

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

Intervention Type OTHER

Compensatory Nutrition (NC)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire Interuniversitaire de Biologie de la Motricité

OTHER

Sponsor Role collaborator

Target Tape

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Saint-Etienne

Saint-Etienne, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Natacha GERMAIN, PhD

Role: CONTACT

(0)477120621 ext. +33

Florence RANCON, Cheffe de projet

Role: CONTACT

(0) 477829458 ext. +33

Facility Contacts

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Natacha GERMAIN, PhD

Role: primary

(0)477120621 ext. +33

Florence RANCON, Cheffe de projet

Role: backup

(0) 477829458 ext. +33

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

24CH263

Identifier Type: -

Identifier Source: org_study_id

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