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NCT Number: NCT06188754

Healthy Lifestyles for Bipolar Disorder

The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California

Berkeley, California, 94720, United States

Location status: Recruiting

Location contact

Sheri L Johnson

CONTACT

[email protected]

415-347-6755

About this study

The investigators will conduct a randomized controlled trial (RCT) to examine the effects of time-restricted eating as compared to the mediterranean diet. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. In the mediterranean diet, participants will be asked to follow a food plan that emphasizes vegetables, fruit, whole grains, and olive oil as central dietary components. The investigators aim to test both food plans as additions to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be randomly assigned to TRE or the mediterranean diet for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the end of treatment and at 3, 6 and 12 months after the intervention. If successful, this work will provide a novel, easily implemented and highly acceptable intervention for BD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

include the following:

  • 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
  • Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; medications such as semaglutide will not be an exclusion criteria
  • 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).

Treatment and study plan

Time restricted eating

Behavioral

Limiting food intake to 10 hours per day

Other names: intermittent fasting

Mediterranean Diet

Behavioral

Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.

Primary outcomes

  1. Acceptability

    Time frame: immediately 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.

  2. Adherence to time-restricted eating

    Time frame: Average 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.

  3. Adherence to Mediterranean Diet

    Time frame: Average 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.

  4. Mania

    Time frame: Lower 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

  5. Depression

    Time frame: Lower 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

  6. Self-rated Quality of Life (QOL)

    Time frame: 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

  7. Mania at follow-up

    Time frame: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

    Sustained lower YMRS scores across follow-up

  8. Depression at follow-up

    Time frame: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

    Sustained lower MADRS scores across follow-up

  9. QOL at follow-up

    Time frame: Brief 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

Secondary outcomes

  1. Self-rated mania

    Time frame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline

    Lower Patient Health Questionnaire (PHQ) Mania scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention

  2. Self-rated depression

    Time frame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline

    Lower Patient Health Questionnaire (PHQ) Depression scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention

  3. Sleep hygiene behaviors

    Time frame: post-intervention (10 weeks) as compared to baseline

    Lower scores on the Sleep Household Environment and In-Bed Behaviors at end-of-treatment (10 weeks) as compared to baseline

  4. Weekly change in mania severity

    Time frame: Weekly scores from the end of the intervention through one-year post-intervention follow-up

    Lower Longitudinal Interval Follow-up Evaluation (LIFE) weekly Mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 3, 6, and 12-months after the intervention, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until one year after the intervention ends.

  5. Sleep disturbance and sleep impairment

    Time frame: post-treatment (10 weeks) as compared to baseline

    Lower scores on the Patient Outcomes Reporting Information System (PROMIS) sleep disturbance and sleep impairment scores at post-treatment (10 weeks) as compared to baseline

  6. Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)

    Time frame: post-treatment (10 weeks) as compared to baseline

    MCTQ scores will show a smaller proportion of individuals with either early or delayed chronotype (as reflected in standard scoring for the MCTQ) at post-treatment as compared to baseline

  7. Regularity of daily routines (Brief Social Rhythm Questionnaire)

    Time frame: post-treatment (10 weeks) as compared to baseline

    Lower Brief Social Rhythm Questionnaire scores (less irregularity) at post-treatment as compared to baseline

  8. Daily emotional lability as assessed using ecological momentary assessment

    Time frame: mid-point of treatment (6 weeks post study entry) as compared to baseline

    Lower mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at the mid-point of treatment (6 weeks) as compared to baseline. Participants will be asked to complete negative affect ratings several times per day for 8 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 8 days at baseline and at treatment mid-point.

Study contacts

Contact information is provided by the study sponsor or research team.

Nandini Rajgopal, BS

CONTACT

[email protected]

(510) 519-4305

Sheri L Johnson, PhD

CONTACT

[email protected]

(510) 519-4305

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Deakin University
  • Salk Institute for Biological Studies
  • Swinburne University of Technology
  • University College, London
  • University of British Columbia
  • Wellcome Trust

Registry information

Official study title

Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder

Acronym: HL

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jan 3, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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