Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06188754

Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder

Led by University of California, Berkeley · Updated on 2025-02-06

300

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of California, Berkeley

Lead Sponsor

U

University College, London

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two healthy lifestyle plans on people with bipolar disorder who are already receiving medication treatment. The study aims to understand how acceptable time-restricted eating and the Mediterranean diet are for participants, and to see how these diets influence manic and depressive symptoms as well as quality of life. This is a randomized controlled trial comparing these two dietary approaches as additions to usual medical care for bipolar disorder. Participants will first complete daily tracking of their eating, sleep, and mood for two weeks. Then, they will be randomly assigned to follow either a time-restricted eating plan, which limits food intake to a 10-hour window each day, or a Mediterranean diet emphasizing vegetables, fruits, whole grains, and olive oil, for eight weeks. Both groups receive online psychoeducation several times per week and optional coaching sessions. The study includes follow-up assessments at 3, 6, and 12 months after the intervention. During the study, participants will undergo evaluations of their bipolar symptoms, quality of life, and adherence to the assigned diet. Measures include standardized rating scales for mania and depression, sleep patterns, and daily mood variability. Assessments occur at baseline, after the 8-week intervention, and during follow-up visits. Researchers will also monitor how well participants stick to the diets and record any changes in sleep and daily routines. The total participation period extends over a year to evaluate longer-term outcomes.

CONDITIONS

Brief Title

Healthy Lifestyles for Bipolar Disorder

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 related conditions)
  • Current sleep or circadian rhythm problems indicated by self-report or interview
  • Living in an English-speaking country with research expertise
  • Speaking English well, demonstrated during screening
  • Receiving medical care for bipolar disorder
  • Stable mood-stabilizing medication for at least one month
  • Less than 5 kg weight change in past 3 months
  • Eating for 12 or more hours at least twice per week
  • Able to use a camera and complete web-based surveys
  • Not doing shift work or having responsibilities that disrupt sleep regularly
  • Able to complete 7 days of dietary logs during baseline
  • Able to complete screening and baseline questionnaires adequately
Not Eligible

You will not qualify if you...

  • Current episode of depression, hypomania, mania, or psychosis
  • History or diagnosis of eating disorder
  • Alcohol or substance use disorder in past 3 months
  • Active suicidal thoughts with plan or intent
  • Conditions interfering with participation (e.g., pregnancy, breastfeeding, thyroid disorders, gastrointestinal issues)
  • Medical conditions that could affect mood assessments (e.g., HIV, lupus, multiple sclerosis)
  • Use of medications contraindicated for fasting (e.g., clozapine, certain diabetes medications, corticosteroids)
  • Cognitive deficits indicated by screening tests

AI-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 or online) for screening and baseline questionnaires

Outpatient Treatment

Duration - 8 weeks

Participants receive behavioral interventions by following either time-restricted eating or the Mediterranean diet alongside their standard medication for bipolar disorder.

Brief online psychoeducation several times per week with optional weekly coaching sessions

Follow-up

Duration - Up to 12 months post-intervention

Participants complete symptom, quality of life, and treatment mechanism assessments after the intervention ends to monitor ongoing effects.

Assessments at 1.5, 3, 6, and 12 months after treatment completion

Trial Site Locations

Total: 1 location

1

University of California

Berkeley, California, United States, 94720

Actively Recruiting

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Research Team

S

Sheri L Johnson, PhD

N

Nandini Rajgopal, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder.

Sheri L Johnson, Greg Murray, Lance J Kriegsfeld...

https://pubmed.ncbi.nlm.nih.gov/38762486