Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder
Led by University of California, Berkeley · Updated on 2025-02-06
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Participants Needed
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8 weeks
Total Duration
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Brief Title
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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
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
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
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
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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
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...