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Healthy Lifestyles for Bipolar Disorder Study

This study is looking at how two healthy eating plans, Time Restricted Eating (limiting food intake to 10 hours a day) and the Mediterranean diet (a diet rich in vegetables, fruits, whole grains, and olive oil), affect people with bipolar disorder. The goal is to see if these eating plans are acceptable and if they can help improve manic and depressive symptoms, as well as your overall quality of life. You may be able to join if you are 18-65 years old, have bipolar I or II disorder, and are currently experiencing sleep problems. The study will measure how well participants follow the diets and how their symptoms and quality of life change. The current recruitment status is unclear.

Study design
This is a randomized controlled trial (RCT) comparing two different eating plans. It plans to enroll 300 participants.
What's involved
You will complete daily measures of eating, sleep, and mood for two weeks. Then, you will follow one of the two food plans for eight weeks.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms and quality of life will be measured at the end of treatment and at 3, 6, and 12 months after the intervention.

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NCT06188754

Healthy Lifestyles for Bipolar Disorder

Recruiting
NAAges 18–65InterventionalTreatment
University of California, Berkeley
~300 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Time restricted eatingMediterranean diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability
Measured over immediately post-treatment (10 weeks after enrollment)
+8 more outcomes measured

Conditions

Time Restricted Eating
Diet, Mediterranean

Explore related trials

Bipolar I disorderBipolar II Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sheri L Johnson, PhD · PRINCIPAL_INVESTIGATOR · University of California, Berkeley

Who to contact

Sheri L Johnson, PhD
[email protected]
(510) 519-4305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)
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 we 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 BD (referrals will be provided for those who would like to begin care)
Mood-stabilizing medication regimens stable for at least one month
\< 5 kg weight change in the past 3 months
Currently eating ≥ 12 hours per day at least twice per week
Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., \> 3 h between 22:00 and 05:00 h for at least 1 day/week)
Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of \< 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, we will manually review for possible invalidity.

Exclusion

Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
Conditions that would interfere with ability to take part in the intervention , including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption,
Medical conditions such as HIV, AIDS, lupus, or multiple sclerosis that could confound the assessment of mania or other measures
Cognitive deficits as noted during the initial interview or as indicated by low performance on the Short Orientation Memory Concentration Test (\< 20 on the weighted score).

What this trial measures

  • Acceptabilityimmediately post-treatment (10 weeks after enrollment)

    Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.

  • Adherence to time-restricted eatingAverage number of daily food logs showing adherence across the 8-week intervention

    Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.

  • Adherence to Mediterranean DietAverage number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)

    Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.

  • ManiaLower YMRS at the end of intervention (10 weeks) as compared to baseline

    Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater

  • DepressionLower MADRS at the end of intervention (10 weeks) as compared to baseline

    Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater

  • Self-rated Quality of Life (QOL)Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline

    Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 1.5-months post intervention as compared to baseline

  • Mania at follow-upYMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

    Sustained lower YMRS scores across follow-up

  • Depression at follow-upMADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

    Sustained lower MADRS scores across follow-up

  • QOL at follow-upBrief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline

    Sustained higher Brief QOL.BD scores