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Can a 10-Hour eating window stabilize mood in bipolar disorder?

NCT ID NCT06188754

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests whether two different eating plans—time-restricted eating (eating within a 10-hour window each day) and a Mediterranean diet—can help people with bipolar disorder. Participants will track their eating, sleep, and mood for two weeks, then follow one of the diets for eight weeks. Researchers will measure changes in manic and depressive symptoms and quality of life, and see how acceptable and sustainable each diet is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Time-restricted eating (limiting food intake to 10 hours per day) and a Mediterranean diet (emphasizing vegetables, fruits, whole grains, and olive oil)
What this could lead to
If effective, these eating plans could offer simple, drug-free ways to help manage mood symptoms and improve quality of life for people with bipolar disorder.
What could go wrong
This is an early-stage trial, and it's unclear if either diet will meaningfully change symptoms. Adherence to the eating plans may be challenging, and results may not apply to everyone with bipolar disorder.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California

    RECRUITING

    Berkeley, California, 94720, United States

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