Healthy Lifestyles in Bipolar Disorder: Bay Area Study

NCT ID: NCT06555406

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2029-02-01

Brief Summary

The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.

Detailed Description

This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.

Conditions

Bipolar Disorder; Time Restricted Eating

Study Design

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

Study Groups

Time Restricted Eating (TRE) for 8 weeks

Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window \> 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.

Group Type: EXPERIMENTAL

Time-restricted eating for 8 weeks

Intervention Type: BEHAVIORAL

limiting food intake to 10 hours per day

Interventions

Time-restricted eating for 8 weeks

limiting food intake to 10 hours per day

Intervention Type: BEHAVIORAL

Other Intervention Names

intermittent fasting

Eligibility Criteria

Inclusion Criteria

• Meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, bipolar disorder Not otherwise specified or bipolar disorder due to another medical condition) assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders [DIAMOND])
• current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview
• Living in an English-speaking country (and one that the researchers have expertise in research procedures and diet)
• Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.
• Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)
• Mood-stabilizing medication regimens stable for at least one month
• < 5 kg weight change in the past 3 months
• Currently eating ≥ 12 hours per day at least twice per week
• Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
• Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., > 3 h between 22:00 and 05:00 h for at least 1 day/week)
• Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
• Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of < 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, their answers will be manually reviewed for possible invalidity.

Exclusion Criteria

• Current episode of depression, hypomania or mania, or psychosis (assessed by the DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
• Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
• Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
• Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
• Conditions that would interfere with ability to take part in the intervention, including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption
• Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis
• Cognitive deficits as noted during the initial interview or as indicated by low performance on the Orientation Memory Concentration Test- Short Version (weighted score < 20)

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

Sponsors

Salk Institute for Biological Studies

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Swinburne University of Technology

OTHER

Sponsor Role: collaborator

Deakin University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheri L Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

University of California Berkeley

Berkeley, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sheri L Johnson, PhD

Role: CONTACT

calmprogram@berkeley.edu

(510) 519-4305

Nandini A Rajgopal, BS

Role: CONTACT

calmprogram@berkeley.edu

(510) 519-4305

Facility Contacts

Nandini Rajgopal, BS

Role: primary

calmprogram@berkeley.edu

(510) 519-4305

Sheri L Johnson, PhD

Role: backup

calmprogram@berkeley.edu

(510) 519-4305

References

Johnson SL, Murray G, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Bower CD, Berle EF, Joyner K, Villanueva R, Michalak EE, Kriegsfeld LJ. A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 Oct 21;24(1):711. doi: 10.1186/s12888-024-06157-5.

Reference Type: DERIVED

PMID: 39434066 (View on PubMed)

Other Identifiers

TRE_Study2

Identifier Type: -

Identifier Source: org_study_id