Trial Outcomes & Findings for The Role of the Circadian System in Binge Eating Disorder (NCT NCT04724668)
NCT ID: NCT04724668
Last Updated: 2026-08-21
Results Overview
Difference in mean DLMO (measured in hours) between subjects with binge eating disorder (BED) and control subjects without BED.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Phase 1 baseline (visit 0)
Results posted on
2026-08-21
Participant Flow
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
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.
Participant milestones
| Measure |
Morning Light Version+ Melatonin
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
|
Morning Light Version+ Placebo
Morning light version and placebo capsule (3hrs before DLMO)
|
Control Group
Adults with obesity without binge eating disorder
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
41
|
|
Overall Study
COMPLETED
|
13
|
12
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
Morning Light Version+ Melatonin
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
|
Morning Light Version+ Placebo
Morning light version and placebo capsule (3hrs before DLMO)
|
Control Group
Adults with obesity without binge eating disorder
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Out of window
|
1
|
0
|
0
|
|
Overall Study
Early withdrawal
|
0
|
0
|
2
|
Baseline Characteristics
Includes data from phase 2 participants with BED that were randomized and had endpoint data. Includes data from controls.
Baseline characteristics by cohort
| Measure |
Morning Light Version+ Melatonin
n=14 Participants
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
|
Morning Light Version+ Placebo
n=12 Participants
Morning light version and placebo capsule (3hrs before DLMO)
|
Control Group
n=37 Participants
Adults with obesity without BED. Only participated in the phase 1 observational study. This group did not receive an intervention.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data. Includes data from controls.
|
39.9 years
STANDARD_DEVIATION 10.3 • n=109 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data. Includes data from controls.
|
42.1 years
STANDARD_DEVIATION 6.6 • n=133 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data. Includes data from controls.
|
39.65 years
STANDARD_DEVIATION 8.85 • n=86 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data. Includes data from controls.
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
12 Participants
n=109 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
36 Participants
n=133 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
62 Participants
n=86 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
0 Participants
n=109 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
1 Participants
n=133 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
1 Participants
n=86 Participants • Includes data from phase 2 participants with BED that were randomized and had endpoint data
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
7 Participants
n=133 Participants
|
11 Participants
n=86 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=109 Participants
|
28 Participants
n=133 Participants
|
49 Participants
n=86 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
3 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=109 Participants
|
37 Participants
n=133 Participants
|
63 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
PRIMARY outcome
Timeframe: Phase 1 baseline (visit 0)Difference in mean DLMO (measured in hours) between subjects with binge eating disorder (BED) and control subjects without BED.
Outcome measures
| Measure |
Binge Eating Disorder
n=35 Participants
Participants with obesity with binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
Control Group
n=34 Participants
Individuals with obesity without binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
|---|---|---|
|
Phase 1 Dim Light Melatonin Onset (DLMO)
|
21.03 hours
Standard Deviation 61
|
20.13 hours
Standard Deviation 69
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Binge Eating Disorder
n=11 Participants
Participants with obesity with binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
Control Group
n=10 Participants
Individuals with obesity without binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
|---|---|---|
|
Phase 2 Dim Light Melatonin Onset (DLMO)
|
0.03 hours
Standard Deviation 1.57
|
-0.27 hours
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Binge Eating Disorder
n=35 Participants
Participants with obesity with binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
Control Group
n=37 Participants
Individuals with obesity without binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
|---|---|---|
|
Phase 1 MEQ
|
54.7 MEQ score
Standard Deviation 8.7
|
54.3 MEQ score
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Binge Eating Disorder
n=14 Participants
Participants with obesity with binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
Control Group
n=11 Participants
Individuals with obesity without binge eating disorder that completed phase 1 with a dim light melatonin onset assessment
|
|---|---|---|
|
Phase 2 Binge Eating Days/Week
|
-2.9 binge eating days/week change
Standard Deviation 3.1
|
-3.5 binge eating days/week change
Standard Deviation 2.4
|
Adverse Events
Morning Light Version+ Melatonin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Morning Light Version+ Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Morning Light Version+ Melatonin
n=14 participants at risk
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
|
Morning Light Version+ Placebo
n=12 participants at risk
Morning light version and placebo capsule (3hrs before DLMO)
|
Control Group
n=37 participants at risk
Adults with obesity without BED participated only in Phase 1, they did not receive an intervention.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
28.6%
4/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
16.7%
2/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
5.4%
2/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Nervous system disorders
Vivid dreams
|
21.4%
3/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Nervous system disorders
Nausea
|
14.3%
2/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
16.7%
2/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Infections and infestations
Respiratory infection
|
14.3%
2/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
General disorders
Tooth ache
|
14.3%
2/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
General disorders
Fatigue
|
7.1%
1/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
7.1%
1/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge
|
7.1%
1/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Infections and infestations
Streptococcal pharyngitis
|
7.1%
1/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Renal and urinary disorders
Urinary tract infection
|
7.1%
1/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Psychiatric disorders
Low mood
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Reproductive system and breast disorders
Menstrual Pain
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Infections and infestations
Norovirus
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/14 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
8.3%
1/12 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
0.00%
0/37 • 1 month for BED participants in phase 2 from randomization to phase 2 endpoint. Controls represent AEs documented during phase 1 with a duration of two-weeks and they did not receive an intervention.
|
Additional Information
Francisco Romo-Nava (PI)
University of Cincinnati / Lindner Center of Hope
Phone: 513-372-5597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place