Binges and Neural Variability (BEDVAR)

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.

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Diagnostic test: fMRI

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Germany
  • Deutschland (deu)
    • Tübingen, Deutschland (deu), Germany, 72070
      • Psychological Institute, University of Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Binge eating disorder diagnosis
• Subsyndromal binge eating (control)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Binge eating disorder (BED) patients; Individuals with BED diagnosis.	Diagnostic test: fMRI; (Imaging while) performing reward related tasks.
non-BED controls; Individuals that do not experience binges	Diagnostic test: fMRI; (Imaging while) performing reward related tasks.
subsyndromal BED controls; individuals that experience binges but do not fulfill the requirements for BED diagnosis.	Diagnostic test: fMRI; (Imaging while) performing reward related tasks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Else Kröner Fresenius Foundation
• Investigators: Principal Investigator: Nils B Kroemer, Dr, University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: neuroimaging; variability; reward sensitivity; ecological momentary assessment (EMA)
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: BEDVAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No