Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inhibitory Control and Eating Disorders (InhibEating)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850288
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Executive functions are part of the high-level cognitive processes essential to the proper functioning of human cognition. They consist mainly of flexibility, updating and inhibition. Some studies have shown a correlation between executive disorders (impaired executive function) and psychiatric disorders such as obsessive-compulsive disorder or phobias. These executive disorders are related to dysfunctions of the fronto-striatal loops.

In addition, other studies have investigated the link that may exist between eating disorders such as anorexia or bulimia nervosa and executive functioning. Anorexia nervosa, bulimia nervosa and binge eating disorders are eating disorders characterized by a dysfunction in food intake with restriction of food or compulsions as well as strong concerns about the body schema. Concerning the executive functioning, these studies highlight a lack of cognitive flexibility for patients with anorexia nervosa and bulimia nervosa but also dysfunctions depending on the type of pathology (anorexia nervosa or bulimia nervosa). These studies also highlight the beneficial effects of cognitive remediation on people with eating disorders.

However, the investigation of the inhibitory control has not yet been specifically studied. Moreover, since eating disorders are structurally different, a comparison between several pathologies would be interesting to consider.

The aim of this study is to determine if a dysfunction of inhibitory control can be highlighted in people with eating disorders. This study would also allow further researches about cognitive remediation suitable for the specific difficulties encountered in these diseases.


Condition or disease Intervention/treatment
Anorexia Nervosa Bulimia Nervosa Binge Eating Other: Neuropsychological assessment : Stroop task Other: Neuropsychological assessment : Go No Go task

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Inhibitory Control in Eating Disorders (Anorexia Nervosa, Bulimia Nervosa and Binge Eating Disorder)
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Group/Cohort Intervention/treatment
Anorexia Nervosa
Patients with a diagnosis of anorexia nervosa (According to the DSM-V criteria). These patients are characterized by a restriction of food intake leading to weight loss or a failure to gain weight resulting in a "significantly low body weight" of what would be expected for someone's age, sex and height. Moreover, there is a fear of becoming fat or of gaining weight.Then, these patients have a distorted view of themselves and of their condition.
Other: Neuropsychological assessment : Stroop task

Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink.

This test is non-invasive.


Other: Neuropsychological assessment : Go No Go task

Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus.

This test is non-invasive.


Bulimia Nervosa

Patients with a diagnosis of bulimia nervosa. According to the DSM-V criteria, these patients are characterized by recurrent episodes of binge eating (eating, in a discrete period of time, an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances), a sense of lack of control over eating during the episode, recurrent inappropriate compensatory behaviour in order to prevent weight gain, such as self-induced vomiting, misuse of laxatives, diuretics, or other medications, fasting, or excessive exercise.

The binge eating and inappropriate compensatory behaviours both occur, on average, at least once a week for three months. Moreover, there is a self-evaluation influenced by body shape and weight.

Other: Neuropsychological assessment : Stroop task

Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink.

This test is non-invasive.


Other: Neuropsychological assessment : Go No Go task

Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus.

This test is non-invasive.


Binge Eating Disorder
Patients with a diagnosis of Binge Eating Disorder. These patients are characterized by recurrent episodes of binge eating (eating, in a discrete period of time (e.g. within any 2-hour period), an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances), a sense of lack of control over eating during the episode. The binge eating episodes are associated with three or more of the following: eating much more rapidly than normal, eating until feeling uncomfortably full, eating large amounts of food when not feeling physically hungry, eating alone because of feeling embarrassed by how much one is eating, feeling disgusted with oneself, depressed or very guilty afterward,marked distress regarding binge eating is present. Moreover, binge eating occurs, on average, at least once a week for three months
Other: Neuropsychological assessment : Stroop task

Stroop task is an interference task assessing cognitive inhibitory control. This "paper-and-pencil" task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink.

This test is non-invasive.


Other: Neuropsychological assessment : Go No Go task

Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus.

This test is non-invasive.





Primary Outcome Measures :
  1. Inhibition processes assessment - the Stroop task, Execution time [ Time Frame: 1 day ]
    Execution time in the Stroop task

  2. Inhibition processes assessment - the Stroop task, Errors [ Time Frame: 1 day ]
    Errors in the Stroop task

  3. Inhibition processes assessment - the Go No Go task, Execution time [ Time Frame: 1 day ]
    Execution time in the Go No Go task.

  4. Inhibition processes assessment - the Go No Go task, Variability of execution time [ Time Frame: 1 day ]
    Variability of execution time in the Go No Go task

  5. Inhibition processes assessment - the Go No Go task, Errors [ Time Frame: 1 day ]
    Errors in the Go No Go task



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 19 to 40 years old, with a BMI between 13 and 40 kg/m2, outpatients of the Refering Center of Eating Disorders ('Hospices Civils de Lyon' in Lyon), with an eating disorder diagnosis (Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder).
Criteria

Inclusion Criteria:

  • Woman aged 19 to 40 years old
  • Patient with a BMI between 13 and 40 kg/m2
  • Outpatients of the Refering Center of Eating Disorders ('Hospices Civils de Lyon' in Lyon) suffering of an eating disorder diagnosis (Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder)
  • Patient who agrees to participate to the study.

Exclusion Criteria:

  • Patient with psychiatric comorbidity
  • Patient with psychotropic treatment
  • Major patient protected by a measure of legal protection
  • Patient younger than 19 years old
  • Participation to another study at the same time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850288


Contacts
Layout table for location contacts
Contact: Bérénice SEGRESTIN, Dr 04 27 85 60 11 ext +33 berenice.segrestin@chu-lyon.fr
Contact: Perrine BERTRAND, Neuropsychologist 04 27 85 60 22 ext +33 perrine.bertrand@chu-lyon.fr

Locations
Layout table for location information
France
Centre Référent pour l'Anorexie et les Troubles du Comportement Alimentaire Recruiting
Bron, France, 69500
Contact: Bérénice SEGRESTIN, Dr    04 27 85 60 11 ext +33    berenice.segrestin@chu-lyon.fr   
Contact: Perrine BERTRAND, Neuropsychologist    04 27 85 60 22 ext +33    perrine.bertrand@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03850288     History of Changes
Other Study ID Numbers: 69HCL18_0621
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia