The Role of the Circadian System in Binge Eating Disorder

Phase 1

Completed

• Conditions: Circadian Rhythm Disorders; Binge-Eating Disorder

• Registration Number: NCT04724668
• Lead Sponsor: University of Cincinnati

Brief Summary

Binge eating disorder (BED) shows prominent circadian features that suggest a delay in circadian phase, and preliminary evidence shows binge eating may be responsive to chronobiological interventions, implicating a circadian system dysfunction in its pathophysiology. What remains lacking, however, is comprehensive knowledge of the characteristics of circadian system dysfunction in BED, and whether this dysfunction represents a therapeutic target in BED. There is therefore a critical need to characterize circadian system dysfunction in BED, and evaluate it as a potential therapeutic target. Without such information, the understanding on the role of the circadian system in BED and its potential as a new therapeutic target will remain limited.

Detailed Description

The overall objective of the research strategy will be to characterize circadian system dysfunction in BED and its potential as a therapeutic target. The central hypothesis is that a circadian system dysfunction (phase delay) plays a role in the pathophysiology of BED, and that advancing the circadian phase will improve BED symptoms. To attain the overall objectives, the following specific aims will be pursued in two phases:

Specific aim 1) To characterize circadian system dysfunction in BED (Phase 1). Circadian system function will be evaluated in 80 adult (18 to 50yrs) obese subjects, 40 with BED and 40 without BED as a control group matched by age, body mass index (BMI), and gender, during a two-week observational phase. Based on preliminary data, the working hypothesis is that DLMO (the primary outcome measure) and secondary circadian parameters (i.e., locomotor activity acrophase) will occur later in the BED group compared with the control group, and a later circadian phase will be associated with worse BED clinical features.

Specific aim 2) To evaluate circadian phase as a predictive biomarker for response to a chronobiological intervention and evidence of circadian system target engagement in BED (Phase 2). A mechanistic clinical trial with a 4-week double-blinded, randomized, sham/placebo controlled study design will evaluate the effect of a combination of morning lights+Melatonin/placebo on the circadian system and eating behavior on 40 BED subjects that complete phase 1. Subjects will be randomized to receive a combination of morning lights at usual wake time + Melatonin(3mg) or placebo (3hr before DLMO). Based on preliminary data, the working hypothesis is that a chronobiological intervention will induce a greater DLMO advance (primary outcome measure), greater decrease in binge eating days/week (secondary outcome measure), and change in exploratory metabolic outcomes. In addition, a later baseline DLMO (secondary outcome) will predict change in binge eating days/week and metabolic parameters in response to a chronobiological intervention.

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-26
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Phase 1 Dim Light Melatonin Onset (DLMO)	Phase 1 baseline (visit 0)	Difference in mean DLMO (measured in time) between subjects with binge eating disorder (BED) and control subjects without BED.
Phase 2 Dim Light Melatonin Onset (DLMO)	Phase 2 baseline (visit 0) to endpoint, on average one month.	Differences in DLMO (measured in time) change from baseline to endpoint between two intervention groups will be analyzed using an ANCOVA model with age as a covariate.

Secondary Outcome Measures

Name	Time	Method
Phase 1 Association between DLMO and binge eating days/week	Phase 1 baseline (visit 0)	The association between DLMO (measured in time) and binge eating days/week in BED subjects.
Phase 2 Locomotor activity acrophase	Phase 2 baseline (visit 0) to endpoint, on average one month.	Differences in locomotor activity acrophase from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Phase 1 Midline Estimating Statistic of Rhythm (MESOR)	Phase 1 baseline (visit 0)	Difference in mean MESOR (7 days) measured in time between BED and control subjects without BED
Phase 2 baseline (visit 0) to endpoint	Phase 2 baseline (visit 0) to endpoint, on average one month.	Differences in MESOR (Midline Estimating Statistic of Rhythm) from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Phase 1 Locomotor activity acrophase	Phase 1 baseline (visit 0)	Difference in mean locomotor activity acrophase (7 days) measured in time between BED and control subjects without BED
Phase 2 Binge eating days/week	Phase 2 baseline (visit 0) to endpoint, on average one month.	Differences in Binge eating days/week from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Phase 1 MEQ	Phase 1 baseline (visit 0)	Difference in mean Morningness Eveningness Questionnaire scores (MEQ) between BED and control subjects without BED. MEQ score range 18 to 86, lower scores indicate more eveningness, higher scores indicate more morningness.

Trial Locations

Locations (1)

Lindner Center of HOPE / University of Cincinnati; 🇺🇸 Mason, Ohio, United States