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

Primary Purpose

Anorexia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical activity program (APA)
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorexia Nervosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Without adapted physical activity program (APA)

    With adapted physical activity program (APA)

    Arm Description

    Outcomes

    Primary Outcome Measures

    To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism
    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

    To evaluate the effects of adapated physical activity program on anthropometric data.
    Anthropometric data
    To evaluate the involving of gut microbiota composition and diversity
    gut microbiota analyses
    To evaluate the effects of adapated physical activity program on quality of life
    Self-administered questionnaires assessing the quality of life
    To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation
    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 Body composition (fat mass, fat free mass)
    Mesaurement of fat and free mass

    Full Information

    First Posted
    June 25, 2020
    Last Updated
    March 23, 2021
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04817436
    Brief Title
    Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
    Acronym
    APANOR
    Official Title
    Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia Nervosa

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Without adapted physical activity program (APA)
    Arm Type
    Active Comparator
    Arm Title
    With adapted physical activity program (APA)
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    physical activity program (APA)
    Intervention Description
    adapted physical activity program (APA)
    Primary Outcome Measure Information:
    Title
    To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism
    Description
    Variation of plasmatic kynurenin acid between V1 and V2 in patients undergoing APA during refeeding versus other patients (control group without APA)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    To evaluate the effects of adapated physical activity program on anthropometric data.
    Description
    Anthropometric data
    Time Frame
    3 months
    Title
    To evaluate the involving of gut microbiota composition and diversity
    Description
    gut microbiota analyses
    Time Frame
    3 months
    Title
    To evaluate the effects of adapated physical activity program on quality of life
    Description
    Self-administered questionnaires assessing the quality of life
    Time Frame
    3 months
    Title
    To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation
    Description
    Dosage of auto-antibodies against neuropeptides involved in food intake regulation using ELISA method (enzyme-linked immunosorbent assay)
    Time Frame
    3 months
    Title
    To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)
    Description
    Mesaurement of fat and free mass
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female Patient > 18 years Follow-up in the department of clinical Nutrition of Rouen BMI ≥15,0 and <18,5 kg/m² Diagnosis of anorexia nervosa according to DSM-V classification Exclusion Criteria: Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension Patients with poor understanding of spoken or written French Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults Person subject to a safeguard of justice, guardianship or curatorship. Pregnant or breastfeeding woman

    12. IPD Sharing Statement

    Learn more about this trial

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