Time-Restricted Eating and Bipolar Disorder

Time-Restricted Eating as an Adjunctive Intervention for Bipolar Disorder: Acceptability and Feasibility

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

Study Overview

• Status: Terminated
• Conditions: Bipolar Disorder
• Intervention / Treatment: Behavioral: time-restricted eating

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: time-restricted eating; Post-baseline, participants will be asked to restrict their eating to a 10-hour window.	Behavioral: time-restricted eating; Restrict eating to a 10-hour window.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability as assessed using self-ratings on items designed for this study	self-ratings of the acceptability of the intervention	Immediately post-treatment (10 weeks)
Feasibility as assessed by percent of clients who complete the assessments and intervention	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.	Immediately post-treatment (10 weeks)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Higher Functional impairment on the World Health Organization Disability Assessment Schedule (WHO-DAS2.0)	WHO-DAS2.0 nonphysical health-related scales	Change from baseline to immediatly post-treatment (10 weeks)

Collaborators and Investigators

• Sponsor: University of California, Berkeley

Publications and helpful links

Helpful Links

• link to study team website

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: eating; circadian
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 2022-10-15725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be available at OSF post-study.
• IPD Sharing Time Frame: Within one year of study completion, if ethics board approves.
• IPD Sharing Access Criteria: Available through OSF.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No