Blue-Blocking Glasses + Time-Restricted Eating for Bipolar Mania
(CIS Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Hospital Research Institute
Must not be taking: Hypoglycemia-inducing
Disqualifiers: Eating disorders, Brain injury, Neurocognitive, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
6891112Eligibility 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
+2 more
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
+4 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Blue-blocking glasses and time-restricted eatingExperimental Treatment2 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 eatingActive Control1 Intervention
Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.
Group III: Lightly tinted glasses and time-restricted eatingActive Control2 Interventions
Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ottawa Hospital Research InsituteOttawa, Canada
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Who Is Running the Clinical Trial?
Ottawa Hospital Research InstituteLead Sponsor
References
Irregular eating patterns associate with hypomanic symptoms in bipolar disorders. [2021]Objective: We present novel dimensional methods to describe the timing of eating in psychopathology. We focused on the relationship between current mood in bipolar disorder (BD) and the stability of the temporal pattern of daily eating events. Methods: Consenting BD patients (n = 69) from an outpatient, tertiary care clinic completed hourly charts of mood and eating for two weeks. Mood was also evaluated with Montgomery-Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Results: Illustrative displays, or eatograms, enabling visualization of all recorded eating events were used to guide assessment of the temporal structure of eating across the two week assessment period. We computed indices to quantify irregularities in timing of eating, namely IFRQ, ITIM and IINT for the variability of frequency, timing, and interval of eating events, respectively. In this cohort, irregular temporal pattern of eating correlated with hypomanic symptoms (YMRS with IFRQ, Spearman rank order rh = 0.28, p = .019, with ITIM, rh = 0.44, p < .001, and with IINT rh = 0.38, p = .001), but not depressive symptoms or anthropometric measures. Conclusions: Our data suggest a link between the instability of the temporal order of daily eating and mood. The dimensional measures for eating pattern introduced here enable future investigations of correlations with psychopathology.
Comorbidity of binge eating disorder and the partial binge eating syndrome with bipolar disorder. [2004]The authors examined the prevalence of binge eating disorder (BED), partial binge eating syndrome, and night binge eating syndrome in subjects with bipolar disorder (BD).
Evening chronotype, disordered eating behavior, and poor dietary habits in bipolar disorder. [2021]Our aim was to evaluate the relationship between evening chronotype, a proxy marker of circadian system dysfunction, and disordered eating behavior and poor dietary habits in individuals with bipolar disorder (BD).
Relationship between bipolar illness and binge-eating disorders. [2008]In this study we describe the frequency of eating disorders (EDs) in a group of bipolar (BP) patients. We evaluated a sample of 51 outpatients, diagnosed as having BP I disorder on the basis of the Structured Clinical Interview for DSM-IV (SCID). Each of these subjects was administered the Binge Eating Disorder Clinical Interview (BEDCI) to determine the presence of binge eating disorder (BED) or bulimia nervosa (BN). Of the 51 BP patients, 14 (9 BED, 5 BN) met criteria for an ED. Most patients developed binge eating coincident with the first episode of BP disorder or after the onset of it. This was true for those who developed BED as well as BN, and involved both manic and depressive phases. All BN patients were women (5/5), and family history of binge eating was present in 80% of BN subjects, but only in 22.2% of BED and 29.7% of non-ED BP patients. We found a high frequency of concordance between BP illness and binge eating problems in our sample of BP patients. Given the temporal sequence of the mood disorder, which generally preceded the ED, we suggest a model in which the ED evolves due to modulation of emotions with food, as well as use of medications to treat BP disorder that disrupt hunger and satiety mechanisms. Given differences in gender distribution and family history, cultural and familial influences may also be significant in the minority of BP binge-eating patients who develop BN.
The association between meal timing and frequency with cardiometabolic profile in patients with bipolar disorder. [2018]The goal of this study was to explore the association of timing of and frequency of meals with markers of cardiometabolic risk in patients with bipolar disorder in out-patient maintenance treatment.
Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We also investigated the effect of the low-calorie, high-fat, low-carbohydrate, and low-protein "fasting snack" on blood glucose.
Safety of 8-h time restricted feeding in adults with obesity. [2019]This study examines the safety of time restricted feeding (TRF; 8-h feeding window/16-h fasting window daily) in obese adults. Twenty-three subjects participated in an 8-h TRF intervention for 12 weeks. Self-reported adverse events, body image perception, complete blood count, and disordered eating patterns did not change from baseline to week 12. These findings suggest that consuming food within an 8-h window can safely facilitate weight loss in subjects with obesity.
Time-restricted feeding is associated with mental health in elderly Italian adults. [2021]In recent years, mental disorders have represented a relevant public health problem due to their deleterious effect on quality of life and the difficulty of timely diagnosis. The growing trends have been shown to be highly influenced by modern society, unhealthy lifestyle and harmful dietary habits. Not only the specific foods or dietary patterns have been hypothesized to play a role on mental health; also, temporal regulation of feeding and fasting has emerged as an innovative strategy to prevent and treat mental health disease. The aim of this cross-sectional study was to investigate the association between time-restricted feeding (TRF) and mental health outcomes including perceived stress, depressive symptoms, and sleep quality assessed in a cohort of southern Italian adults. Demographic and dietary characteristics of 1,572 adults living in southern Italy were analyzed. Food frequency questionnaires were used to calculate dietary intakes; participants were also asked what time, on average, they consumed their meals to calculate the eating window of time and identify those eating within 8 hours or less. Logistic regression analyses were performed to test the association between mental health outcomes. After adjusting for potential confounding factors, including adherence to the Mediterranean diet and having breakfast/dinner, no associations were found between TRF and mental health outcomes; however, when performing the analyses by age groups, individuals older than 70 years having a feeding time window of 8 hours were less likely to have signs of mental health distress [odds ratio (OR) = 0.14, 95% confidence interval (CI): 0.03-0.65] compared to those having no feeding time restriction independently of diet quality; notably, adjusting for having breakfast nullified the association (OR = 0.13, 95% CI: 0.02-1.18), while adjusting for having dinner did not change it (OR = 0.14, 95% CI: 0.03-0.67). No further associations were found for specific mental health outcomes explored separately. In conclusion, restricting the daily time feeding window is associated with lower signs of mental health distress in individuals older than 70 years. Albeit preliminary, these findings on elderly individuals require further investigation using prospective design and an amended approach to control for fasting.
Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]Time-restricted eating (TRE) can facilitate weight loss, yet its effect on eating patterns remains unknown. Twenty adults with BMI ≥ 25 kg/m2 underwent a 12-week randomized trial, examining the effect of an 8-h, time-restricted eating intervention on dietary patterns. Oral intake was documented using a smartphone. Dietary patterns, assessed as frequency of eating occasions (EOs) and types of meals/snacks and beverages, were compared between baseline (T0), early-intervention (T1), and end-intervention (T2). At T1 and T2, both groups had less EOs compared to T0, with greater reduction seen in the TRE group (-28%) than the non-TRE group (-12%) at T2 (p = 0.01 vs. non-TRE). Comparing T1 to T0, the TRE group documented less incomplete meals (-32.5%: p = 0.02), high quality snacks (-23.6%: p = 0.03), and low quality snacks (-36.6%: p = 0.004). Comparing T2 to T0, the TRE group documented less incomplete meals (-33.9%: p = 0.03), high quality snacks (-28.1%: p < 0.001) and low quality snacks (-51.2%: p < 0.001). Caffeinated beverage intake was reduced in the TRE group at T1 (-20.2%) and T2 (-28.8%) vs. T0, but remained unaltered in the non-TRE group. By using a smartphone application to document dietary intake, TRE significantly reduced the number of EOs, snacks, and caffeinated beverages, relative to baseline and relative to the non-TRE.
Intermittent fasting implementation and association with eating disorder symptomatology. [2022]Intermittent fasting (IF) is an emerging dietary trend that remains understudied. This study aimed to describe the implementation and eating disorder (ED) symptomatology, relevant to engagement in IF among both men and women. Intermittent fasters (N = 44 women, N = 20 men) recruited from Amazon Mechanical Turk, Reddit, and a Midwestern University were administered a demographic questionnaire, an assessment of ED symptomatology (Eating Disorder Examination Questionnaire; EDE-Q), and asked about their IF use. To assess the level of ED symptomatology among individuals using IF community and clinical norms were used for comparison. We hypothesized a) men and women engaging IF would score higher on the EDE-Q and b) more individuals engaging in IF would endorse ED behaviors (e.g., self-induced vomiting) than community norms. Intermittent fasters reported fasting for approximately 16 hours daily and for weight loss purposes. Men and women engaging in IF scored significantly higher than community norms on all subscales of the EDE-Q, with 31.25% of participants' EDE-Q scores being at or above the clinical EDE-Q cut-off. Men and women engaging in IF reported engaging in ED behaviors. Results suggest that IF is associated with ED symptomatology. Further research on psychological characteristics and temporal order of the association between IF and ED symptomatology is warranted.
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]The aim of this study is to assess the acceptability of following three different fasting protocols [Early Time-restricted Feeding (eTRF; eating majority of kcals before 5pm), Time-restricted Feeding (TRF; restricting feeding window to 8 h/d), or Alternate Day Fasting (ADF; complete fasting every other day)].
Time-Restricted Eating to Improve Cardiovascular Health. [2021]Time-restricted eating (TRE) is a form of intermittent fasting that involves confining the eating window to 4-10 h and fasting for the remaining hours of the day. The purpose of this review is to summarize the current literature pertaining to the effects of TRE on body weight and cardiovascular disease risk factors.