Blue-Blocking Glasses + Time-Restricted Eating for Bipolar Mania

(CIS Trial)

Overseen By Jessica Yu, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Hypoglycemia-inducing

Disqualifiers: Eating disorders, Brain injury, Neurocognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking hypoglycemia-inducing medications, you cannot participate in the trial.

What data supports the effectiveness of the treatment Blue-Blocking Glasses + Time-Restricted Eating for Bipolar Mania?

Research suggests that irregular eating patterns are linked to mood instability in people with bipolar disorder, and time-restricted eating may help stabilize these patterns. Additionally, blue-blocking glasses can improve sleep quality, which is often disrupted in bipolar disorder, potentially helping to manage mood symptoms. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) and time-restricted feeding (TRF) have been studied in adults with obesity and found to be generally safe, with no significant changes in adverse events or disordered eating patterns over 12 weeks. However, intermittent fasting (IF) has been associated with eating disorder symptoms in some individuals, suggesting that while TRE/TRF can be safe, IF may not be suitable for everyone. ^{6 7 8 9 10}

How does the treatment of blue-blocking glasses and time-restricted eating for bipolar mania differ from other treatments?

This treatment is unique because it combines blue-blocking glasses, which may help regulate sleep patterns by reducing exposure to blue light, with time-restricted eating, a form of intermittent fasting that confines eating to specific hours. Unlike traditional medications for bipolar mania, this approach focuses on lifestyle changes that may influence mental health through improved sleep and metabolic regulation. ^{6 8 9 11 12}

What is the purpose of this trial?

The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination.

Research Team

Jess G Fiedorowicz, MD, PhD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for individuals experiencing mania as part of bipolar disorder. Participants should be interested in non-medication therapies and willing to try special glasses or change their eating patterns. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate.

Inclusion Criteria

I am over 16 years old.

I have manic symptoms not caused by substances with a YMRS score of 20 or more.

Be willing to have investigators obtain information from the treatment team and electronic medical record

Exclusion Criteria

Have a history of eating disorders

I have had a serious brain injury, surgery, or stroke with lasting effects.

Have a neurocognitive disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blue-blocking glasses, time-restricted eating, or both as interventions for mania

2 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Qualitative Interviews

Interviews conducted to assess feasibility and identify barriers to treatment

End of participation

Treatment Details

Interventions

• Blue-blocking glasses
• Time-restricted eating

Trial Overview The study tests the effectiveness of blue-blocking glasses and time-restricted eating on managing symptoms of mania in bipolar disorder. It aims to see if these treatments can help regulate sleep-wake cycles without medication, using interviews and symptom tracking.

Participant Groups

Group I: Blue-blocking glasses and time-restricted eating Experimental Treatment 2 Interventions

Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am.

Group II: Blue-blocking glasses and no time-restricted eating Active Control 1 Intervention

Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.

Group III: Lightly tinted glasses and time-restricted eating Active Control 2 Interventions

Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

In a study of 69 bipolar disorder patients, irregular patterns in the timing of daily eating events were found to correlate with hypomanic symptoms, indicating that mood instability may influence eating behaviors.

The research introduced new methods to quantify eating patterns, which could help in understanding the relationship between eating habits and mood disorders in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irregular eating patterns associate with hypomanic symptoms in bipolar disorders. Buyukkurt, A., Bourguignon, C., Antinora, C., et al.[2021]

In a study of 61 individuals with bipolar disorder, 13% were diagnosed with binge eating disorder (BED) and 25% exhibited partial binge eating syndrome, indicating a higher prevalence of these eating disorders compared to community samples.

The study also found that 10 subjects reported night binge eating, typically occurring between 2:00 and 4:00 a.m., suggesting a potential link between mood regulation and binge eating behaviors in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidity of binge eating disorder and the partial binge eating syndrome with bipolar disorder. Krüger, S., Shugar, G., Cooke, RG.[2004]

In a study of 783 adults with bipolar disorder, those with an evening chronotype exhibited significantly higher rates of disordered eating behaviors, including binge-eating and bulimia nervosa, as well as poorer dietary habits compared to non-evening types.

The findings suggest that circadian system dysfunction, indicated by evening chronotype, may contribute to unhealthy eating patterns in bipolar disorder patients, highlighting the potential for targeting circadian rhythms in future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evening chronotype, disordered eating behavior, and poor dietary habits in bipolar disorder. Romo-Nava, F., Blom, TJ., Guerdjikova, A., et al.[2021]

In a study of 51 outpatients with bipolar disorder, 14 patients (27.5%) were found to have eating disorders, specifically binge eating disorder (BED) or bulimia nervosa (BN), indicating a significant overlap between these conditions.

The majority of patients developed their eating disorders either coinciding with or after the onset of bipolar disorder, suggesting that emotional regulation through food may play a role in the development of these eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between bipolar illness and binge-eating disorders. Ramacciotti, CE., Paoli, RA., Marcacci, G., et al.[2008]

In patients with bipolar disorder, later dinnertime is linked to increased waist circumference, suggesting that meal timing may influence cardiometabolic risk.

Longer intervals between breakfast and lunch are also associated with greater waist circumference, indicating that meal frequency and timing could play a role in managing weight and cardiovascular health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between meal timing and frequency with cardiometabolic profile in patients with bipolar disorder. Soreca, I., Wallace, ML., Hall, MH., et al.[2018]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

In a study of 1,572 southern Italian adults, time-restricted feeding (TRF) was associated with lower signs of mental health distress in individuals over 70 years old, suggesting a potential benefit of this dietary pattern for older adults.

However, the association was influenced by whether participants had breakfast, indicating that meal timing and dietary habits may interact in complex ways affecting mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding is associated with mental health in elderly Italian adults. Currenti, W., Godos, J., Castellano, S., et al.[2021]

In a 12-week study involving 20 adults with a BMI of 25 kg/m2 or higher, time-restricted eating (TRE) significantly reduced the frequency of eating occasions by 28% compared to only 12% in the non-TRE group, indicating a more structured eating pattern.

TRE participants also reported a notable decrease in both high and low-quality snacks and caffeinated beverage intake, suggesting that this eating pattern not only aids in weight loss but also promotes healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. Malaeb, S., Harindhanavudhi, T., Dietsche, K., et al.[2022]

Intermittent fasting (IF) participants, consisting of 44 women and 20 men, reported higher levels of eating disorder (ED) symptomatology compared to community norms, with 31.25% scoring at or above the clinical cutoff on the Eating Disorder Examination Questionnaire (EDE-Q).

The study indicates a concerning association between IF and ED behaviors, suggesting that individuals engaging in IF may be at risk for developing or exhibiting disordered eating patterns, highlighting the need for further research on this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting implementation and association with eating disorder symptomatology. Cuccolo, K., Kramer, R., Petros, T., et al.[2022]

In a study involving 32 participants over six weeks, the Time-restricted Feeding (TRF) diet was found to be the most acceptable, with participants reporting it as the easiest to follow compared to Early Time-restricted Feeding (eTRF) and Alternate Day Fasting (ADF).

Despite differences in dietary acceptability, there were no significant differences in weight loss or energy intake among the three fasting protocols, indicating that adherence may be more influenced by personal preference than by the specific diet's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. Turner-McGrievy, GM., Wirth, MD., Bernhart, JA., et al.[2022]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Irregular eating patterns associate with hypomanic symptoms in bipolar disorders. [2021]

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

Comorbidity of binge eating disorder and the partial binge eating syndrome with bipolar disorder. [2004]

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

Evening chronotype, disordered eating behavior, and poor dietary habits in bipolar disorder. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Relationship between bipolar illness and binge-eating disorders. [2008]

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

The association between meal timing and frequency with cardiometabolic profile in patients with bipolar disorder. [2018]

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

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Time-restricted feeding is associated with mental health in elderly Italian adults. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]

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

Intermittent fasting implementation and association with eating disorder symptomatology. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. [2022]

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

Time-Restricted Eating to Improve Cardiovascular Health. [2021]