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Healthy Lifestyles in Bipolar Disorder: Bay Area Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site contact updatedv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2024 to Nov 22, 2024
    v3
  3. Secondary endpoints: details revised at 6 of 7 entries
    • Eligibility criteria expanded, about 3 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06555406
Lead Sponsor University of California, Berkeley
Collaborators: Salk Institute for Biological Studies, University College, London, Swinburne University of Technology, Deakin University, University of British Columbia, Wellcome Trust
Conditions
(from sponsor)		 Bipolar Disorder, Time Restricted Eating
Related terms Bipolar Disorder, Intermittent Fasting, Sleep Initiation and Maintenance Disorders
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov