Recruiting

Healthy Lifestyles

Sponsor:

UCLA

Code:

NCT06188754

Conditions

Time Restricted Eating

Diet, Mediterranean

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Time restricted eating

Mediterranean diet

Study Details

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.

Conditions

Time Restricted Eating

Diet, Mediterranean

Study ID

NCT06188754

Start date

Jun 5, 2024

Status verified date

Jul, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Dec 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time Restricted Eating (TRE) for 8 weeks

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.

active comparator: Mediterranean diet for 8 weeks

Participants will receive a several page introduction to the mediterranean diet, and then will receive support throughout the 8 week intervention to follow this food plan, including brief online psychoeducation that will be sent several times per week, and optional weekly coaching sessions.

The mediterranean diet is a plan for healthy eating based on how people eat in the mediterranean region. Individuals will be encouraged to consume vegetables (6 servings/day), fruits (2-4 servings/day), whole grains (daily), legumes (3-4 times per week), nuts (.5 oz per day), and oily fish (2 servings/week). Participants will be encouraged to choose lean meats and other sources of protein over red meat and processed meats. Sweets, refined cereals, alcohol, and wine or alcohol will be labelled as extras, and participants will be encouraged to limit consumption of extras.

Interventions

Time restricted eating

Limiting food intake to 10 hours per day

Mediterranean diet

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

Primary outcome measure

  • Acceptability [ Time Frame: immediately post-treatment (10 weeks after enrollment) ]
  • Adherence to time-restricted eating [ Time Frame: Average number of daily food logs showing adherence across the 8-week intervention ]
  • 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) ]
  • Mania [ Time Frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline ]
  • Depression [ Time Frame: Lower MADRS at the end of intervention (10 weeks) as compared to baseline ]
  • Self-rated Quality of Life (QOL) [ Time Frame: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline ]
  • Mania at follow-up [ Time Frame: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline ]
  • Depression at follow-up [ Time Frame: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of California

Recruiting

Berkeley, California, United States, 94720

Contacts

More Information

Sponsor

University of California, Berkeley

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • bipolar disorder
  • sleep
  • circadian rhythm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Berkeley on 2026-08-04.