Clinical trial NCT06188754: Healthy Lifestyles for Bipolar Disorder
Official title: Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time Restricted Eating
Diet, Mediterranean
Keywords: bipolar disorder
sleep
circadian rhythm
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: University College, London
name: Swinburne University of Technology
name: Deakin University
name: University of British Columbia
name: Salk Institute for Biological Studies
name: Wellcome Trust
First posted: 2024-01-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to take part in either time-restricted eating or the Mediterranean diet.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Acceptability
timeFrame: immediately post-treatment (10 weeks after enrollment)
measure: Adherence to time-restricted eating
timeFrame: Average number of daily food logs showing adherence across the 8-week intervention
measure: Adherence to Mediterranean Diet
timeFrame: 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)
measure: Mania
timeFrame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline
measure: Depression
timeFrame: Lower MADRS at the end of intervention (10 weeks) as compared to baseline
measure: Self-rated Quality of Life (QOL)
timeFrame: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline
measure: Mania at follow-up
timeFrame: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
measure: Depression at follow-up
timeFrame: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
measure: QOL at follow-up
timeFrame: Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline
Secondary outcomes:
measure: Self-rated mania
timeFrame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
measure: Self-rated depression
timeFrame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
measure: Sleep hygiene behaviors
timeFrame: post-intervention (10 weeks) as compared to baseline
measure: Weekly change in mania severity
timeFrame: Weekly scores from the end of the intervention through one-year post-intervention follow-up
measure: Sleep disturbance and sleep impairment
timeFrame: post-treatment (10 weeks) as compared to baseline
measure: Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)
timeFrame: post-treatment (10 weeks) as compared to baseline
measure: Regularity of daily routines (Brief Social Rhythm Questionnaire)
timeFrame: post-treatment (10 weeks) as compared to baseline
measure: Daily emotional lability as assessed using ecological momentary assessment
timeFrame: mid-point of treatment (6 weeks post study entry) as compared to baseline
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Berkeley
name: Sheri L Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: