Circadian Rhythm Interventions for Binge Eating Disorder
(CHRONO-BE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how the body's internal clock (circadian rhythm) might influence binge eating disorder (BED) and whether adjusting this clock could help treat BED. Participants will receive treatments such as melatonin (a hormone that regulates sleep) or morning light exposure (also known as Bright Light Therapy or Phototherapy) to determine if these can reduce binge eating episodes. Those diagnosed with BED, who experience frequent binge eating (three or more episodes a week), and are not currently on certain medications might be suitable for this study. The goal is to discover new ways to help people manage BED by focusing on their body's natural rhythms.
As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking BED treatment strategies.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that affect the circadian system, like B-blockers, hypnotic sedatives, anticoagulants, antidiabetes drugs, oral corticosteroids, and other immunosuppressants. If you are on these medications, you should discuss with the trial team to see if adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that melatonin is usually safe for use. In studies on night-eating syndrome, similar to binge eating disorder, melatonin did not cause major side effects. Some participants experienced mild sleepiness, but this was neither serious nor common.
Morning light therapy has also proven safe for many people. It has been used for conditions like Seasonal Affective Disorder (SAD) without major safety issues. Some individuals might experience mild eye strain or headaches, but these effects typically do not last long.
Both treatments have been safely used in other contexts. Although this trial is in its early stages, existing research suggests these treatments are generally safe to try.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for binge eating disorder because they tap into the body's natural circadian rhythms for potential solutions. Unlike current medications, which often focus on neurotransmitter balance, these treatments use melatonin and morning light exposure to potentially reset the body's internal clock. This approach targets the timing and regulation of biological processes, which could provide a novel and more holistic way to manage binge eating behaviors. By addressing the underlying circadian misalignments, these treatments might offer benefits with fewer side effects compared to traditional pharmacological options.
What evidence suggests that this trial's treatments could be effective for binge eating disorder?
Research has shown that melatonin can help manage the sleep-wake cycle, often off-balance in people with binge eating disorder (BED). Studies suggest that melatonin might improve sleep quality and reduce binge eating by enhancing the body's internal clock function. In this trial, some participants will receive melatonin alongside morning light therapy.
Morning light therapy has also shown promise in boosting mood and reducing unhealthy eating habits. Exposure to bright light in the morning can help reset the body's internal clock and improve eating patterns. In this trial, other participants will receive morning light therapy with a placebo. These treatments focus on the body's natural timing system, which may be linked to BED. Early evidence suggests they could help manage symptoms by addressing these timing issues.678910Who Is on the Research Team?
Francisco Romo-Nava, MD, PhD
Principal Investigator
University of Cincinnati/ Lindner Center of HOPE
Are You a Good Fit for This Trial?
This trial is for adults aged 18-50 with a BMI of ≥30 kg/m2 and diagnosed with moderate to severe Binge Eating Disorder (BED) as per DSM-5 criteria. Participants should not be on any new BED medication or have started psychotherapy within the last 2 or 3 months, respectively. Other moderate psychiatric conditions are allowed if stable, and effective contraception must be used by those who can bear children.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational Phase
Circadian system function is evaluated in 80 adult obese subjects, 40 with BED and 40 without BED as a control group.
Treatment
A 4-week double-blinded, randomized, sham/placebo controlled study to evaluate the effect of morning lights and Melatonin/placebo on the circadian system and eating behavior.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Melatonin
- Morning light version 1
- Morning light version 2
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Cincinnati
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Lindner Center of HOPE
Collaborator