Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06555406

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

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

150

Participants Needed

1

Research Sites

218 weeks

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

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.

CONDITIONS

Official 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...

  • Diagnosed with bipolar I or bipolar II disorder (not cyclothymia or other bipolar types) confirmed by DIAMOND interview
  • Reports some sleep or circadian-related problems
  • Lives in an English-speaking country with research expertise
  • Has spoken English for at least 10 years, uses English at home, or understands English well for the study
  • Receiving medical care for bipolar disorder
  • Mood-stabilizing medication stable for at least 1 month
  • Weight change less than 5 kg in past 3 months
  • Currently eats for 12 hours or more at least twice per week
  • Able to use phone camera and respond to web-based surveys (loaner phones available)
  • Not engaged in shift work or duties that disrupt sleep more than 3 hours between 10 PM and 5 AM at least one day per week
  • Able to complete 7 days of dietary logs adequately during baseline
  • Able to complete screening and baseline questionnaires with attention and validity
Not Eligible

You will not qualify if you...

  • Current episode of depression, hypomania, mania, or psychosis
  • History or current diagnosis of eating disorder
  • Alcohol or substance use disorder in past 3 months
  • Active suicidal thoughts with plan, intent, or past attempts
  • Conditions interfering with participation such as pregnancy, breastfeeding, thyroid disorders, or gastrointestinal problems
  • Conditions affecting immune or study measures like HIV, AIDS, lupus, or multiple sclerosis
  • Use of medications contraindicated for fasting, including clozapine, glucose-lowering drugs, or corticosteroids
  • Cognitive deficits indicated by interview or low test scores

AI-Screening

AI-Powered Screening

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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

CONTACT

N

Nandini A Rajgopal, BS

CONTACT

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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