Anorexia NervosaInhibEatingNCT03850288
Inhibitory Control and Eating Disorders
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa, Binge Eating
- What is being tested?
- Neuropsychological assessment : Stroop task and Neuropsychological assessment : Go No Go task
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2019to 26 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- Patient with psychiatric comorbidity severe (DSM V) and not stable (during the 8 weeks before inclusion)
- Patient with psychotropic treatment (started or modified during the 8 weeks before inclusion)
- Major patient protected by a measure of legal protection
- Patient younger than 19 years old
- Participation to another study at the same time
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Référent pour l'Anorexie et les Troubles du Comportement Alimentaire
Bron, 69500
About this study
Official title: Inhibitory Control in Eating Disorders (Anorexia Nervosa, Bulimia Nervosa and Binge Eating Disorder)
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.
Read more
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge Eating
- Being tested
- Neuropsychological assessment : Stroop task, Neuropsychological assessment : Go No Go task
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessment : Stroop taskOther
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.
Neuropsychological assessment : Go No Go taskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neuropsychological assessment : Stroop task; Other: Neuropsychological assessment : Go No Go task | |
| 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. Receives: Other: Neuropsychological assessment : Stroop task; Other: Neuropsychological assessment : Go No Go task | |
| 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 Receives: Other: Neuropsychological assessment : Stroop task; Other: Neuropsychological assessment : Go No Go task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition processes assessment - the Stroop task, Execution time
Execution time in the Stroop task
Measured: 1 day
Inhibition processes assessment - the Stroop task, Errors
Errors in the Stroop task
Measured: 1 day
Inhibition processes assessment - the Go No Go task, Execution time
Execution time in the Go No Go task.
Measured: 1 day
Inhibition processes assessment - the Go No Go task, Variability of execution time
Variability of execution time in the Go No Go task
Measured: 1 day
Inhibition processes assessment - the Go No Go task, Errors
Errors in the Go No Go task
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start15 May 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850288
- Sponsor's protocol ID
- 69HCL18_0621
- Acronym
- InhibEating
- Status last verified
- Jan 2023
- First submitted
- 15 Feb 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibitory Control in Eating Disorders (Anorexia Nervosa, Bulimia Nervosa and Binge Eating Disorder)
- ClinicalTrials.gov ID
- NCT03850288
- Acronym / sponsor ID
- InhibEating / 69HCL18_0621
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge Eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | – | Other: Neuropsychological assessment : Stroop task, Other: Neuropsychological assessment : Go No Go taskPatients 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. |
| Bulimia Nervosa | – | Other: Neuropsychological assessment : Stroop task, Other: Neuropsychological assessment : Go No Go taskPatients 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. |
| Binge Eating Disorder | – | Other: Neuropsychological assessment : Stroop task, Other: Neuropsychological assessment : Go No Go taskPatients 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 |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Patient with psychiatric comorbidity severe (DSM V) and not stable (during the 8 weeks before inclusion)
- Patient with psychotropic treatment (started or modified during the 8 weeks before inclusion)
- Major patient protected by a measure of legal protection
- Patient younger than 19 years old
- Participation to another study at the same time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessment : Stroop taskStroop 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 | Anorexia Nervosa, Binge Eating Disorder, Bulimia Nervosa |
| Neuropsychological assessment : Go No Go taskGo 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. | Other | Anorexia Nervosa, Binge Eating Disorder, Bulimia Nervosa |
Primary outcome
Inhibition processes assessment - the Stroop task, Execution time
Time frame: 1 day
Execution time in the Stroop task
Inhibition processes assessment - the Stroop task, Errors
Time frame: 1 day
Errors in the Stroop task
Inhibition processes assessment - the Go No Go task, Execution time
Time frame: 1 day
Execution time in the Go No Go task.
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
Inhibition processes assessment - the Go No Go task, Errors
Time frame: 1 day
Errors in the Go No Go task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
Recruiting
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Hepatic Cytolysis
Active, not recruiting
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Anorexia Nervosa
Not yet recruitingPhase 2
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Specialist Supportive Clinical Management (SSCM) for Children and Adolescents With Anorexia Nervosa and Atypical Anorexia Nervosa
Anorexia Nervosa, Atypical Anorexia Nervosa
Recruiting
Influence of Control Deprivation on the Use of the Analytical Cognitive Style in Anorexic Subjects
Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition processes assessment - the Stroop task, Execution time (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.