Circadian Rhythm Interventions for Binge Eating Disorder

(CHRONO-BE Trial)

Overseen by Francisco Romo-Nava, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Cincinnati

Must not be taking: B-blockers, sedatives, anticoagulants, others

Disqualifiers: Severe MDD, substance use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if exposing patients with Binge Eating Disorder to morning light and giving them a Melatonin pill can help reset their body clock and reduce binge eating. Melatonin is a hormone involved in appetite regulation and food intake, and its supplementation has been studied for its potential to restore balance in cases of circadian disruption. The study focuses on obese adults aged 18-50.

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.

What data supports the effectiveness of the treatment for Binge Eating Disorder?

Research suggests that bright light therapy, a component of the treatment, can reduce binge eating episodes in individuals with eating disorders by helping to regulate circadian rhythms, which are often disrupted in these conditions. ^{1 2 3 4 5}

Is bright light therapy safe for humans?

Bright light therapy is generally considered safe for humans, as it is a noninvasive treatment used for various conditions, including eating disorders. Studies have shown it can be used without significant adverse effects. ^{1 2 4 5 6}

How does the circadian rhythm intervention treatment differ from other treatments for binge eating disorder?

This treatment is unique because it focuses on regulating the body's natural 24-hour cycle (circadian rhythm) to address binge eating disorder, using methods like bright light exposure to improve mood and eating patterns. Unlike traditional treatments that may focus solely on behavior or nutrition, this approach targets the underlying biological rhythms that can contribute to disordered eating. ^{1 2 3 6 7}

Research Team

Francisco Romo-Nava, MD, PhD

Principal Investigator

University of Cincinnati/ Lindner Center of HOPE

Eligibility Criteria

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

Current BED diagnoses by Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria confirmed by Structured Clinical Interview (SCID-5)

Moderate or severe BED (≥3 binge eating episodes/week in the past 14 days)

I have been in stable psychotherapy for 3 months and will continue it during the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Phase

Circadian system function is evaluated in 80 adult obese subjects, 40 with BED and 40 without BED as a control group.

2 weeks

1 visit (in-person)

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.

4 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Melatonin (Other)
• Morning light version 1 (Behavioural Intervention)
• Morning light version 2 (Behavioural Intervention)
• Placebo (Other)

Trial Overview The study tests whether interventions like melatonin taken before the body's natural dim light melatonin onset (DLMO), or exposure to morning light therapy can help manage BED by targeting circadian system dysfunction. It compares these treatments against a placebo to see which is more effective.

Participant Groups

Group I: Morning light version+ Placebo Experimental Treatment 2 Interventions

Morning light version and placebo capsule (3hrs before DLMO)

Group II: Morning light version+ Melatonin Experimental Treatment 2 Interventions

Morning light version and melatonin 3mg capsule (3hrs before DLMO)

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Dr. Greg Postel

University of Cincinnati

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Dr. Neville G. Pinto

University of Cincinnati

Chief Executive Officer since 2017

PhD in Chemistry from the University of Virginia

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Lindner Center of HOPE

Collaborator

Trials

29

Recruited

1,400+

Findings from Research

In a study involving 34 females with binge-eating disorder and bulimia nervosa, morning bright light exposure significantly reduced binge eating and food preoccupation for those with high dietary restraint and negative affect.

These results suggest that morning bright light could be an effective complementary treatment for individuals with binge-spectrum eating disorders, particularly for those who are harder to treat due to their specific psychological profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses to bright light exposure in individuals with binge-spectrum eating disorders characterized by high dietary restraint and negative affect. Kambanis, PE., Bottera, AR., De Young, KP.[2023]

Individuals with eating disorders often experience disrupted eating rhythms, characterized by delayed mealtime peaks and atypical hunger patterns, which may lead to binge-eating episodes later in the day.

The proposed biobehavioral circadian model suggests that circadian disruptions play a significant role in the development and maintenance of restrictive and binge eating behaviors, indicating that interventions aimed at regulating circadian rhythms could enhance the effectiveness of existing eating disorder treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biobehavioral circadian model of restrictive eating and binge eating. De Young, KP., Bottera, AR.[2022]

Women with Binge Eating Disorder (BED) showed significant differences in their circadian rhythm compared to a control group, with reduced MESOR and Amplitude, but improved sleep quality after undergoing a structured multidisciplinary therapy.

The study, which included 28 women (14 with BED and 14 controls) monitored over 5 days, found that the BED group had better synchronization of their rest-activity rhythms and higher sleep efficiency, suggesting that a regular lifestyle can positively impact sleep patterns in patients with eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The multidisciplinary therapy in binge eating disorder is able to influence the interdaily stability and sleep quality? Galasso, L., Montaruli, A., Mulè, A., et al.[2020]

In a study of 34 female outpatients with bulimia nervosa, those receiving 10,000 lux bright light therapy experienced a significant reduction in binge frequency compared to those receiving a placebo dim red light treatment.

Despite the improvement in binge eating behaviors, the study found no significant differences in depressive symptoms between the two groups, indicating that the light therapy specifically targeted binge eating rather than overall mood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy decreases winter binge frequency in women with bulimia nervosa: a double-blind, placebo-controlled study. Braun, DL., Sunday, SR., Fornari, VM., et al.[2019]

In a study involving 10 patients with anorexia nervosa (AN) and 12 with anorexia nervosa and bulimic symptoms (AN + BN), the AN + BN group showed significantly higher daytime and nighttime levels of sulphatoxy-melatonin (aMT6s) compared to both the AN group and healthy controls, suggesting a potential link between melatonin output and the severity of symptoms.

The findings indicate that altered melatonin levels may reflect greater disruptions in circadian rhythms in patients with AN + BN, which could influence the progression of their illness, although no significant differences were observed between the two patient groups after 7 or 14 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effects of starvation on 6-sulphatoxy-melatonin output in subgroups of patients with anorexia nervosa. Kennedy, SH., Brown, GM., Ford, CG., et al.[2019]

Misalignment of food intake with our natural circadian rhythms can lead to serious health issues like obesity and disordered eating, particularly in evening-type individuals who tend to skip meals and eat late at night.

Chronotherapeutic interventions, such as bright light therapy, show promise in reducing disordered eating behaviors, but more research is needed to fully understand their effects on metabolic disorders and obesity-related eating issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding and Eating Disorders in the Context of Circadian Rhythms. Kandeğer, A., Eğilmez, Ü., Selvi, Y.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Responses to bright light exposure in individuals with binge-spectrum eating disorders characterized by high dietary restraint and negative affect. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A biobehavioral circadian model of restrictive eating and binge eating. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The multidisciplinary therapy in binge eating disorder is able to influence the interdaily stability and sleep quality? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Bright Light Therapy for Eating Disorders. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Bright light therapy decreases winter binge frequency in women with bulimia nervosa: a double-blind, placebo-controlled study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The acute effects of starvation on 6-sulphatoxy-melatonin output in subgroups of patients with anorexia nervosa. [2019]

7. Turkey pubmed.ncbi.nlm.nih.gov

Feeding and Eating Disorders in the Context of Circadian Rhythms. [2022]