NCT04724668

The Role of the Circadian System in Binge Eating Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Binge-Eating Disorder
• Circadian Rhythm Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin (3hrs before DLMO)	Melatonin 3mg (3hrs before DLMO)
DIETARY_SUPPLEMENT	Placebo (3hrs before DLMO)	Placebo capsule (3hrs before DLMO)
DEVICE	Morning light version 1	Morning light version
DEVICE	Morning light version 2	Morning light version

Timeline

• Start date: 2021-01-15
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2021-01-26
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study