Intermittent Fasting for Bipolar Disorder

N/A

Recruiting

Led By Sheri L Johnson, PhD

Research Sponsored by University of California, Berkeley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study how following a time-restricted eating plan affects daily rhythms in the body's clock genes, and how this may impact symptoms of mania and depression in individuals with bipolar disorder.

Who is the study for?

This trial is for individuals with bipolar I or II disorder, who speak English and have been on a stable mood-stabilizing medication regimen for at least one month. They should not have had significant weight changes recently, eat over a 12-hour period regularly, and can use a phone camera and web surveys. People with sleep disorders or those doing shift work that disrupts sleep are excluded.

What is being tested?

The study tests if following an 8-week time-restricted eating plan affects the body's natural rhythms and if these changes can improve mania and depression symptoms in people with bipolar disorder. Participants will also track their eating, sleep, mood daily before starting TRE.

What are the potential side effects?

While specific side effects are not detailed here, time-restricted eating may lead to hunger outside of eating windows, potential changes in energy levels during fasting periods, possible headaches or irritability due to adjustments in meal timing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depression

Mania

Self-rated Quality of Life (QOL)

Secondary study objectives

Acceptability

Daily emotional lability as assessed using ecological momentary assessment

Depression at follow-up

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Time Restricted Eating (TRE) for 8 weeksExperimental Treatment1 Intervention

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.

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