Body clock linked to binge eating: new study reveals clues
NCT ID NCT04724668
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study looked at whether people with binge eating disorder have a disrupted body clock. Researchers compared 43 adults with and without the condition, measuring melatonin levels and activity patterns. The goal was to understand how the circadian system might be involved, which could lead to new treatments in the future.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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84 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 exclusion criteria: 1. Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease 2. Chronic treatment with BLT or melatonin in the past month 3. Routine shift work (work at night) in the past month 4. Travel across more than 1 time zone in the past two weeks 5. Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year 6. 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 7. Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements 8. Pregnant or breastfeeding 9. Participation in a clinical trial in the past month 10. Suspected IQ\<80 11. Any other clinically relevant reason as judged by the clinician
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lindner Center of HOPE / University of Cincinnati
Mason, Ohio, 45040, United States
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Other studies related to the condition(s) this trial covers.
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