Comparing healthy eating plans for bipolar disorder

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

This study is testing whether following a time-restricted eating plan or a Mediterranean diet can help people with bipolar disorder feel better while they are on medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of California, Berkeley (Academic / other)
• Locations: 1 site (Berkeley, California)
• Trial ID: NCT06188754 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effects of time-restricted eating and the Mediterranean diet on individuals with bipolar disorder who are already receiving medication. Participants will complete daily measures of eating, sleep, and mood for two weeks before being randomly assigned to one of the two dietary plans for eight weeks. The study will assess changes in manic and depressive symptoms, as well as Quality of Life, at various intervals during and after the intervention. The goal is to determine the acceptability and effectiveness of these dietary approaches as adjuncts to standard medication treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with bipolar I or II disorder who experience sleep or circadian rhythm issues and are currently receiving stable medication treatment.

Not a fit: Patients with cyclothymia or bipolar disorder due to another medical condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel and easily implemented dietary intervention that improves symptoms and Quality of Life for patients with bipolar disorder.

How similar studies have performed: While dietary interventions in mental health are being explored, this specific comparison of time-restricted eating and the Mediterranean diet in bipolar disorder is relatively novel.

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).

Where this trial is running

Berkeley, California

• University of California — Berkeley, California, United States (Recruiting)

Study contacts

• Principal investigator: Sheri L Johnson, PhD — University of California, Berkeley
• Study coordinator: Sheri L Johnson, PhD

Conditions Time Restricted Eating; Diet, Mediterranean; bipolar disorder; sleep; circadian rhythm