Binge-Eating DisorderBEDVARNCT04184856
Binges and Neural Variability
An observational study of Binge-Eating Disorder, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
People who suffer from binge eating disorder experience recurrent episodes of binge eating.During these episodes, they consume an unusually large amount of food in a short amount of time and experience loss of control over eating. However, why such binge eating episodes occur is still largely unknown. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- fMRI
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2019to 31 May 2021
- 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The control group will consist of residents of the general area around Tübingen, Germany. BED patients will be recruited mainly from the outpatient clinic of the Department of Clinical Psychology of Tübingen, Germany.
Who may be able to join
- Binge eating disorder diagnosis
- Subsyndromal binge eating (control)
Who cannot join
- high risk of suicide
- co-occurring psychotic, bi-polar disorders, alcohol/substance dependence within the past six months
- lack of capacity for consent
- medical disorders that would affect weight and ability to participate
- insufficient German language skills (assessment will be in German)
- taking medication that would affect weight
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- MRI exclusion criteria
- irremovable metal attached to the body (e.g. piercings)
- irremovable medical devices (e.g. pacemakers)
- any trauma or surgery which may have left ferromagnetic material in the body
- large tattoos
- pregnancy
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychological Institute, University of Tübingen
Tübingen, Deutschland (deu), 72070
About this study
Official title: What is Driving the Binge in Binge Eating Disorder? Variability in Brain Response to Reward and the Escalation of Consumption
People who suffer from binge eating disorder experience recurrent episodes of binge eating.During these episodes, they consume an unusually large amount of food in a short amount of time and experience loss of control over eating. However, why such binge eating episodes occur is still largely unknown. This makes it difficult to develop targeted treatments. In this project, the experimenters are investigating the brain mechanisms that give rise to the disorder. They hypothesize that the binge eating episodes are due to an increased variability in reward processing, which they will assess repeatedly over days. They will test this hypothesis using mathematical models based on behavioural and MRI measurements that are related to the processing of rewards.
- Conditions
- Binge-Eating Disorder
- Being tested
- fMRI
- Keywords
- reward sensitivity, neuroimaging, variability, ecological momentary assessment (EMA)
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDiagnostic test
(Imaging while) performing reward related tasks.
| Study group | Role | What they receive |
|---|---|---|
| Binge eating disorder (BED) patients | Individuals with BED diagnosis. Receives: Diagnostic Test: fMRI | |
| non-BED controls | Individuals that do not experience binges Receives: Diagnostic Test: fMRI | |
| subsyndromal BED controls | individuals that experience binges but do not fulfill the requirements for BED diagnosis. Receives: Diagnostic Test: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task
Variability of BOLD signal in the nucleus accumbens (NAcc) over time and between trials while performing an effort allocation task. The signal is measured through functional magnetic resonance imaging (fMRI) and variability is determined through model residuals.
Measured: 100 min
Trial-to-trial variability in reward seeking in an effort allocation task
Variability of performance is an intra-individual measure, that is defined by the residuals of a linear mixed effects model of trial-to-trial performance on the effort allocation task.
Measured: 40 min
Variability in BOLD signalling in the NAcc for food-cue reactivity
Variability of BOLD signal in the NAcc between blocks of food pictures. The signal is measured through fMRI and variability is determined through model residuals.
Measured: 15
Secondary outcomes (1)
Variability in BOLD signalling in the NAcc during non-food-cue reactivity
Variability of BOLD signal in the NAcc between blocks of non-food pictures. The signal is measured through fMRI and variability is determined through model residuals.
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start6 Dec 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Responsible party
- Sponsor
- Investigators
- Nils B Kroemer, Dr, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184856
- Sponsor's protocol ID
- BEDVAR
- Acronym
- BEDVAR
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is Driving the Binge in Binge Eating Disorder? Variability in Brain Response to Reward and the Escalation of Consumption
- ClinicalTrials.gov ID
- NCT04184856
- Acronym / sponsor ID
- BEDVAR / BEDVAR
- Conditions
- Binge-Eating Disorder
- Keywords
- reward sensitivity, neuroimaging, variability, ecological momentary assessment (EMA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 4 Dec 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.
People who suffer from binge eating disorder experience recurrent episodes of binge eating.During these episodes, they consume an unusually large amount of food in a short amount of time and experience loss of control over eating. However, why such binge eating episodes occur is still largely unknown. This makes it difficult to develop targeted treatments. In this project, the experimenters are investigating the brain mechanisms that give rise to the disorder. They hypothesize that the binge eating episodes are due to an increased variability in reward processing, which they will assess repeatedly over days. They will test this hypothesis using mathematical models based on behavioural and MRI measurements that are related to the processing of rewards.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Binge eating disorder (BED) patients | – | Diagnostic Test: fMRIIndividuals with BED diagnosis. |
| non-BED controls | – | Diagnostic Test: fMRIIndividuals that do not experience binges |
| subsyndromal BED controls | – | Diagnostic Test: fMRIindividuals that experience binges but do not fulfill the requirements for BED diagnosis. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The control group will consist of residents of the general area around Tübingen, Germany. BED patients will be recruited mainly from the outpatient clinic of the Department of Clinical Psychology of Tübingen, Germany.
Key inclusion criteria (2 listed)
- Binge eating disorder diagnosis
- Subsyndromal binge eating (control)
Key exclusion criteria (13 listed)
- high risk of suicide
- co-occurring psychotic, bi-polar disorders, alcohol/substance dependence within the past six months
- lack of capacity for consent
- medical disorders that would affect weight and ability to participate
- insufficient German language skills (assessment will be in German)
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 |
|---|---|---|
| fMRI(Imaging while) performing reward related tasks. | Diagnostic test | Binge eating disorder (BED) patients, non-BED controls, subsyndromal BED controls |
Primary outcome
Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task
Time frame: 100 min
Variability of BOLD signal in the nucleus accumbens (NAcc) over time and between trials while performing an effort allocation task. The signal is measured through functional magnetic resonance imaging (fMRI) and variability is determined through model residuals.
Trial-to-trial variability in reward seeking in an effort allocation task
Time frame: 40 min
Variability of performance is an intra-individual measure, that is defined by the residuals of a linear mixed effects model of trial-to-trial performance on the effort allocation task.
Variability in BOLD signalling in the NAcc for food-cue reactivity
Time frame: 15
Variability of BOLD signal in the NAcc between blocks of food pictures. The signal is measured through fMRI and variability is determined through model residuals.
1 secondary outcome
Variability in BOLD signalling in the NAcc during non-food-cue reactivity
Time frame: 5
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 11 Aug 2021.
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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.
Nils B Kroemer, Dr principal investigator
University Hospital Tuebingen
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 Binge-Eating Disorder, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 13 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 11 Aug 2021. 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 Germany. 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?
Variability in blood-oxygen-level dependent (BOLD) signalling in the NAcc during effort allocation task (time frame: 100 min). The study lists 3 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 11 Aug 2021.