Healthy Lifestyles in Bipolar Disorder: Bay Area Study

Part of paid clinical trials in Berkeley, California.

Sponsor
University of California, Berkeley
Study ID
NCT06555406
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Time-restricted eating for 8 weeks — BEHAVIORAL
    limiting food intake to 10 hours per day

Study Details

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.

Key Dates

Start date
Nov 22, 2024
Status verified
Jan 2026
Primary completion
Feb 1, 2029
Completion
Feb 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Time Restricted Eating (TRE) for 8 weeks
    Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window \> 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.

Primary Outcome Measure

Mania [ Time Frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California BerkeleyBerkeleyCalifornia94720-2010
Nandini Rajgopal, BS
[email protected]
(510) 519-4305
Sheri L Johnson, PhD
[email protected]
(510) 519-4305
Sheri L Johnson, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Berkeley, CA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California Berkeley· Berkeley, CA

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