Time-Restricted Eating and Bipolar Disorder

Not Applicable

Terminated

• Conditions: Bipolar Disorder
• Interventions: Behavioral: time-restricted eating

• Registration Number: NCT06105294
• Lead Sponsor: University of California, Berkeley

Brief Summary

This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.

Detailed Description

Time-restricted eating (TRE) is a way of scheduling food intake that has been shown to improve circadian rhythms in animals and humans. TRE is based on animal and human science that shows that the timing of eating powerfully influences diurnal rhythms. Animal research has shown that feeding during sleep periods leads to a surge of norepinephrine, cortisol, wakefulness, and activity. Drawing on this, over a decade of studies have examined the impact of experimentally randomizing mice to time-restricted feeding during wake hours (vs. 24-hour ad libitum feeding). Importantly, caloric intake and other facets of diet were yoked for strict control. A consistent finding is that TRE had powerful benefits for circadian and metabolic indicators across studies,and more recent data also shows benefit for animal longevity.

Here, the investigators' goal is to extend this work to bipolar disorder (BD). More specifically, the investigators will gather data to examine the acceptability and feasibility of TRE among those who self-identify with bipolar disorder and who experience some problems with sleep, circadian rhythms, or schedules. The investigators will gather measures of mania, depression, sleep, and QOL, to provide preliminary evidence of change on these dimensions.

Study Timeline

• Study First Submitted: 2023-02-06
• Study Start: 2023-06-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
• Experiencing schedule/sleep or circadian problem in the past 3 months
• Medication regimens stable for past month
• Adequate English language skills for taking part in the program.
• Living in California.

Exclusion Criteria

• Cognitive deficits (Screening OMC Test)

• Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)

• High scores (> 5) on the Screening Eating Disorder Examination Questionnaire

• Current shift work

• >5 kg weight change within 3 months

• Pregnancy

• Breastfeeding

• Uncorrected hypo or hyperthyroidism

  * diabetes type 1

• Gastrointestinal conditions impairing nutrient absorption

• Medications contraindicated for fasting, including clozapine, glucose-lowering medications, diabetes-related injections, requiring food early morning or late evening, corticosteroids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
time-restricted eating	time-restricted eating	Post-baseline, participants will be asked to restrict their eating to a 10-hour window.

Primary Outcome Measures

Name	Time	Method
Acceptability as assessed using self-ratings on items designed for this study	Immediately post-treatment (10 weeks)	self-ratings of the acceptability of the intervention
Feasibility as assessed by percent of clients who complete the assessments and intervention	Immediately post-treatment (10 weeks)	Percentage of clients who do not drop out of the trial. Drop out would be defined as not completing the TRE intervention, or failing to complete the end-of-treatment intervention.

Secondary Outcome Measures

Name	Time	Method
Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales	Change from baseline to immediately post-treatment (10 weeks)	PROMIS self-report of sleep disturbance and sleep-related impairment (summed together)
higher scores on Self-rated Quality of Life	Change from baseline to immediatly post-treatment (10 weeks)	Brief Quality of Life in Bipolar Disorder scale
Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9	Change from baseline to immediately post-treatment (10 weeks)	Self-Rated Patient Mania Questionnaire-9
Lower Depression symptoms as assessed with the Patient Health Questionnaire-9	Change from baseline to immediately post-treatment (10 weeks)	PHQ-9

Trial Locations

Locations (1)

University of California; 🇺🇸 Berkeley, California, United States