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Recruiting NCT06555406

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

Trial Parameters

Condition Bipolar Disorder
Sponsor University of California, Berkeley
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-11-22
Completion 2029-02-01
Interventions
Time-restricted eating for 8 weeks

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.

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

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