Binge-Eating Disorder, Circadian Rhythm Disorders
Conditions
Keywords
Binge eating, Circadian
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.
Interventions
DIETARY_SUPPLEMENTMelatonin (3hrs before DLMO)
Melatonin 3mg (3hrs before DLMO)
DIETARY_SUPPLEMENTPlacebo (3hrs before DLMO)
Placebo capsule (3hrs before DLMO)
DEVICEMorning light version 1
Morning light version
DEVICEMorning light version 2
Morning light version
Sponsors
University of Cincinnati
National Institute of Mental Health (NIMH)
Lindner Center of HOPE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
On the intervention phase 2 (Specific aim 2). Only subjects with BED (n=40) will participate and be randomly assigned to one of two combinations of morning lights and/or melatonin/placebo (20 subjects/each arm). Researchers and participants will be blinded to the intervention.
Intervention model description
The specific aims will be completed in a two-phase experimental approach. In the first phase (specific aim 1), subjects with obesity with BED (n=40) and without BED (n=40) will participate in a 2-week longitudinal study. In the second phase (specific aim 2), only BED subjects that complete phase 1 will rollover for a 4-week intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Binge Eating Disorder (BED) group inclusion criteria: 1. Age 18-50 years, inclusive 2. Female or male 3. BMI ≥30 kg/m2 4. Current BED diagnoses by Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria confirmed by Structured Clinical Interview (SCID-5) 5. Moderate or severe BED (≥3 binge eating episodes/week in the past 14 days) 6. No current pharmacological treatment for BED, or if receiving treatment dose stable for ≥ 2 months 7. If receiving psychotherapy, intervention must be stable for ≥ 3 months and agree to continue during the study 8. Other psychiatric disorders will be permitted as long as they are not more than moderate in severity 9. Using an effective contraceptive method (participants of childbearing potential) BED
Exclusion criteria
1. Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis) 2. Current (past month) substance use disorder (caffeine and nicotine allowed) 3. Chronic use of bright light therapy (BLT) or melatonin in the past month 4. Current contraindication or history of melatonin allergy or non-tolerability; 5. Current contraindication or history of BLT non-tolerability 6. Significant risk of suicide according to Columbia-Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year 7. Routine shift work (night work) in the past month 8. Travel across more than 1 time zone in the past two weeks 9. Current treatment with medication known to affect the circadian system or melatonin measurements, including: B-blockers, hypnotic sedatives, anticoagulants, antidiabetes drugs, oral corticosteroids, and other immunosuppressant medication 10. Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements 11. Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease 12. Pregnancy or breastfeeding 13. Participation in a clinical trial in the past month 14. Suspected intelligence quotient (IQ) \<80 15. Any other clinically relevant reason as judged by the clinician Control group inclusion criteria: 1. Age 18-50 years, inclusive 2. Female or male; 3. BMI ≥30 kg/m2 4. No current or lifetime history of BED or bulimia nervosa diagnoses confirmed by SCID-5 5. No current (past month) psychiatric diagnosis according to SCID-5, including substance use disorders (caffeine and nicotine allowed) 6. No current psychiatric or psychological treatment, or if receiving treatment dose/intervention stable for ≥ 2 months Control group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Dim Light Melatonin Onset (DLMO) | Phase 1 baseline (visit 0) | Difference in mean DLMO (measured in hours) 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 hours) change from baseline to endpoint between two intervention groups will be analyzed using an ANCOVA model with age as a covariate. Controls did not participate in the intervention (phase 2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrancisco Romo-Nava, MD, PhD
University of Cincinnati/ Lindner Center of HOPE
Participant flow
Recruitment details
Participants were recruited from 01/15/2021 to 05/30/2025 at the Lindner Center of Hope, the University of Cincinnati, and surrounding community through clinical referrals and advertising campaigns. nterested individuals completed an online IRB-approved prescreening questionnaire via Research Electronic Data Capture (REDCap, Vanderbilt University). Eligible candidates were then contacted by the research team to complete either an IRB-approved phone screen or an in-person screening visit. Parti
Pre-assignment details
The study consisted of two consecutive phases: the first phase involved an observational study to characterize circadian system function in adults with obesity with binge eating disorder (BED) compared to a control group with obesity without BED. For the second phase, only participants with BED that completed the first phase rolled over into a mechanistic pilot and feasibility clinical trial to further evaluate the role of the circadian system in BED.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.4 years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 | 0 / 37 |
| other Total, other adverse events | 4 / 14 | 2 / 12 | 2 / 37 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 | 0 / 37 |
Outcome results
None listed