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

March 23, 2021 updated by: University Hospital, Rouen
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Without adapted physical activity program (APA)
Other: physical activity program (APA)
adapted physical activity program (APA)
Experimental: With adapted physical activity program (APA)
Other: physical activity program (APA)
adapted physical activity program (APA)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/0383/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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