Time-Restricted Eating and Bipolar Disorder

NCT ID: NCT06105294

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-07-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

time-restricted eating

Post-baseline, participants will be asked to restrict their eating to a 10-hour window.

Group Type: EXPERIMENTAL

time-restricted eating

Intervention Type: BEHAVIORAL

Restrict eating to a 10-hour window.

Interventions

time-restricted eating

Restrict eating to a 10-hour window.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California

Berkeley, California, United States

Countries

United States

Related Links

https://calm.berkeley.edu/participate/

link to study team website

Other Identifiers

2022-10-15725

Identifier Type: -

Identifier Source: org_study_id