Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa

Study Overview
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Brief Summary
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The purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing too much) compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility. Such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.

Detailed Description
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This is a three steps protocol. First, patients (with anorexia nervosa), controls (with no eating disorder) and first degree relatives (with no eating disorder) will be tested for emotional accuracy (seing faces on a screen with different core emotions), pain threshold (how long they can support a cold probe), body size (how they see themselves), appetite and cognitive flexibility (a test where the capacity to change rules during a game is done easily or not). Then all subjects will do a standardized physical exercise which represents an effort with the equivalent level of energy for each participants as being chosen according to each level of competency (assessed through the maximal aerobic power). The third step consists in the repetition of (nearly) initial tests.

Official Title
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Analysis of the Capacity to Regulate Physical Efforts and to Estimate Its Intensity as an Endophenotype of Anorexia Nervosa, Because of a Specific Impact of the Physical Effort at the Emotional, Cognitive, Pain, Genetic and Biological Level

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires
* Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients : Woman 18 - 50 years eating disorders (with or without bulimia) according to the EDI-2 (Eating Disorder Inventory) and the MINI (Mini International Neuropsychiatric Interview) BMI (Body Mass index) between 14 and 17,5 first degree relative without ED (eating disorders) First degree relatives : Woman 18 - 50 years Mother or sister of patient with eating disorders BMI (Body Mass index) upper to 17,5 Healthy of all ED (eating disorders) Controls : Woman 18 - 50 years BMI > 17,5 Without ED (eating disorders) Exclusion Criteria: All groups : Contraindication in the practice of an intensive sport Cardiovascular Family history with risk of cardiovascular unwanted events Cardiovascular, surgical personal Histories, ostéoarticulaires or musculo-tendinous against indicating to the practice of a sport Intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or acute) Related and controls : Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anorexia nervosa<br>Patients with DSM-5 criteria of anorexia nervosa | Other: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires<br>* Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires<br>|
| Other: First degree relatives<br>First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder | Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires<br>* Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires<br>|
| Other: Controls (with no eating disorder)<br>Other | Other: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires<br>* Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical power | Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain threshold | This threshold is based on the minimum temperature that the patient is able to suppor (the probe is placed on the skin of the forarm, and the temperature reduces its temperature every 10 seconds), knowing that the machine is not getting to temperatures that can be damageable. Comparison before and after bike test | Day 0 | 
| Wellbeing self-questionnaire | Comparison before and after bike test | Day 0 | 
| Hunger Visual analogical scale | Comparison before and after bike test | Day 0 | 
| PANAS score (self-questionnaire) | Emotions. Comparison before and after bike test | Day 0 | 
| Hunger Visual analogical scale | Apetite. Comparison before and after bike test | Day 0 | 
| Performance on the Briton cognitive test (number of errors) | Mental flexibility. Comparison before and after bike test | Day 0 | 
| Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups. | Tests. Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups. | Day 0 | 
| Genetical analysis | 10 candidate genes will be analyzed (following the collection of blood or saliva) assessing the frequency of their main alleles (variants), looking for a significant difference of allele frequency between the 3 groups. | Day 0 |