Brief Summary

Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline

Completed

Started Jun 2006

Longer than P75 for not_applicable obesity

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.3 years study duration

Study Start

First participant enrolled

June 1, 2006

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed

Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

January 10, 2014

Last Update Submit

January 14, 2014

Conditions

Obesity Binge Eating Disorder

Keywords

ObesityBinge eating disorderfMRIgut hormones

Outcome Measures

Primary Outcomes (1)

fMRI responses to food cues
Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition.
45 min

Secondary Outcomes (2)

Gut hormone responses
120 min
Subjective appetite ratings
120 min

Study Arms (2)

Binge eating disorder (BED)

EXPERIMENTAL

Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who meet the current criteria for binge eating disorder (BED) in the fed condition and fasted condition.

Dietary Supplement: Fed ConditionDietary Supplement: Fasted conditionProcedure: Blood samplesBehavioral: Subjective appetite ratingsProcedure: fMRI scan

Control

EXPERIMENTAL

Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who do not meet the current criteria for BED (Controls) in the fed condition and fasted condition.

Dietary Supplement: Fed ConditionDietary Supplement: Fasted conditionProcedure: Blood samplesBehavioral: Subjective appetite ratingsProcedure: fMRI scan