Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06555406

Time-restricted Eating as an Adjunctive Intervention for Bipolar Disorder

Led by University of California, Berkeley · Updated on 2026-01-14

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, Berkeley

Lead Sponsor

S

Salk Institute for Biological Studies

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how sticking to a time-restricted eating (TRE) plan affects daily biological rhythms, mood symptoms, and quality of life in adults with bipolar disorder who are already receiving medication treatment. The study aims to understand how changes in the body's internal clock, measured by gene activity, relate to improvements in mania and depression symptoms, even when considering changes in glucose tolerance and inflammation. This research focuses on people with bipolar disorder who experience sleep or circadian rhythm difficulties. Participants will follow a TRE plan where they limit their eating to a 10-hour window each day for eight weeks, alongside their usual medication. Initially, they will receive an introduction to TRE and then get brief online education several times per week, with optional weekly coaching. If their baseline eating window is longer than 14 hours, they will first reduce it to 12 hours in week one, then to 10 hours in week two. Participants choose their 10-hour eating period based on their usual sleep, family, and social schedules. During the eating window, there are no restrictions on food type or amount, and participants are encouraged to maintain their usual calorie intake. During the study, participants will complete daily records of eating, sleep, and mood for two weeks before starting TRE. They will have assessments of mania, depression, and quality of life at the start, midpoint, end of the 8-week TRE period, and again 3 months later. Researchers will monitor symptom changes, daily emotional fluctuations, and adherence to the eating schedule. The total study participation includes baseline tracking, 8 weeks of TRE, and follow-up assessments up to 16 weeks after starting.

CONDITIONS

Brief Title

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of bipolar I or bipolar II disorder (not cyclothymia or other bipolar types) confirmed by a diagnostic interview
  • Presence of sleep or circadian rhythm problems causing impairment
  • Living in an English-speaking country with ability to understand English well
  • Receiving medical care for bipolar disorder with stable mood-stabilizing medication for at least one month
  • Weight change less than 5 kg in the past 3 months
  • Eating window of 12 hours or more at least twice per week
  • Able to use a phone camera and respond to web surveys
  • Not working night shifts or having responsibilities that disrupt sleep
  • Able to complete 7 days of dietary logs and baseline questionnaires adequately
Not Eligible

You will not qualify if you...

  • Current episode of depression, hypomania, mania, or psychosis
  • History or current diagnosis of an eating disorder
  • Alcohol or substance use disorder in the past 3 months
  • Active suicidal thoughts with plan or intent
  • Conditions interfering with participation such as pregnancy, breastfeeding, thyroid issues, or gastrointestinal problems
  • Conditions affecting immune or study measures like HIV, lupus, or multiple sclerosis
  • Use of medications that conflict with fasting, including clozapine and some diabetes drugs
  • Cognitive deficits indicated by low scores on memory or orientation tests

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants follow time-restricted eating by limiting their food intake to a 10-hour window each day for 8 weeks, alongside standard medication for bipolar disorder. They receive brief online psychoeducation several times per week with optional weekly coaching sessions.

Several online sessions per week with optional weekly coaching

Follow-up

Duration - 3 months post-intervention

Participants complete assessments of symptoms and quality of life at the mid-point and end of treatment, and again at 3 months post-intervention to monitor changes after the time-restricted eating period.

3 follow-up assessments (online or in-person)

Trial Site Locations

Total: 1 location

1

University of California Berkeley

Berkeley, California, United States, 94720-2010

Actively Recruiting

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Research Team

S

Sheri L Johnson, PhD

N

Nandini A Rajgopal, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder.

Sheri L Johnson, Greg Murray, Emily N C Manoogian...

https://pubmed.ncbi.nlm.nih.gov/39434066