Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study

Not Applicable

Not yet recruiting

• Conditions: Anorexia Nervosa
• Interventions: Other: physical activity program (APA)

• Registration Number: NCT04817436
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26
• Study Start: 2021-06-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

1. Female
2. Patient > 18 years
3. Follow-up in the department of clinical Nutrition of Rouen
4. BMI ≥15,0 and <18,5 kg/m²
5. Diagnosis of anorexia nervosa according to DSM-V classification

Exclusion Criteria

1. Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension
2. Patients with poor understanding of spoken or written French
3. Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults
4. Person subject to a safeguard of justice, guardianship or curatorship.
5. Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With adapted physical activity program (APA)	physical activity program (APA)	-
Without adapted physical activity program (APA)	physical activity program (APA)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism	3 months	Variation of plasmatic kynurenin acid between V1 and V2 in patients undergoing APA during refeeding versus other patients (control group without APA)

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)	3 months	Mesaurement of fat and free mass
To evaluate the involving of gut microbiota composition and diversity	3 months	gut microbiota analyses
To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation	3 months	Dosage of auto-antibodies against neuropeptides involved in food intake regulation using ELISA method (enzyme-linked immunosorbent assay)
To evaluate the effects of adapated physical activity program on anthropometric data.	3 months	Anthropometric data
To evaluate the effects of adapated physical activity program on quality of life	3 months	Self-administered questionnaires assessing the quality of life