Bipolar DisorderNCT06105294
Time-Restricted Eating and Bipolar Disorder
A study testing time-restricted eating in people with Bipolar Disorder, run by University of California, Berkeley at 1 site in United States.
Trial summary
This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
- Experiencing schedule/sleep or circadian problem in the past 3 months
- Medication regimens stable for past month
- Adequate English language skills for taking part in the program.
- Living in California.
Who cannot join
- Cognitive deficits (Screening OMC Test)
- Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)
- High scores (> 5) on the Screening Eating Disorder Examination Questionnaire
- Current shift work
- >5 kg weight change within 3 months
- Pregnancy
Show all 11Show fewer
- Breastfeeding
- Uncorrected hypo or hyperthyroidism
- diabetes type 1
- Gastrointestinal conditions impairing nutrient absorption
- Medications contraindicated for fasting, including clozapine, glucose-lowering medications, diabetes-related injections, requiring food early morning or late evening, corticosteroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Berkeley, California, 94720
About this study
Official title: Time-Restricted Eating as an Adjunctive Intervention for Bipolar Disorder: Acceptability and Feasibility
This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.
Read the detailed description
Time-restricted eating (TRE) is a way of scheduling food intake that has been shown to improve circadian rhythms in animals and humans. TRE is based on animal and human science that shows that the timing of eating powerfully influences diurnal rhythms. Animal research has shown that feeding during sleep periods leads to a surge of norepinephrine, cortisol, wakefulness, and activity. Drawing on this, over a decade of studies have examined the impact of experimentally randomizing mice to time-restricted feeding during wake hours (vs. 24-hour ad libitum feeding). Importantly, caloric intake and other facets of diet were yoked for strict control. A consistent finding is that TRE had powerful benefits for circadian and metabolic indicators across studies,and more recent data also shows benefit for animal longevity.
Here, the investigators' goal is to extend this work to bipolar disorder (BD). More specifically, the investigators will gather data to examine the acceptability and feasibility of TRE among those who self-identify with bipolar disorder and who experience some problems with sleep, circadian rhythms, or schedules. The investigators will gather measures of mania, depression, sleep, and QOL, to provide preliminary evidence of change on these dimensions.
- Conditions
- Bipolar Disorder
- Being tested
- time-restricted eating
- Keywords
- eating, circadian
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-restricted eatingBehavioural
Restrict eating to a 10-hour window.
| Study group | Role | What they receive |
|---|---|---|
| time-restricted eating | Experimental | Post-baseline, participants will be asked to restrict their eating to a 10-hour window. Receives: Behavioral: time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability as assessed using self-ratings on items designed for this study
self-ratings of the acceptability of the intervention
Measured: Immediately post-treatment (10 weeks)
Feasibility as assessed by percent of clients who complete the assessments and intervention
Percentage of clients who do not drop out of the trial. Drop out would be defined as not completing the TRE intervention, or failing to complete the end-of-treatment intervention.
Measured: Immediately post-treatment (10 weeks)
Secondary outcomes (4)
Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9
Self-Rated Patient Mania Questionnaire-9
Measured: Change from baseline to immediately post-treatment (10 weeks)
Lower Depression symptoms as assessed with the Patient Health Questionnaire-9
PHQ-9
Measured: Change from baseline to immediately post-treatment (10 weeks)
Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales
PROMIS self-report of sleep disturbance and sleep-related impairment (summed together)
Measured: Change from baseline to immediately post-treatment (10 weeks)
higher scores on Self-rated Quality of Life
Brief Quality of Life in Bipolar Disorder scale
Measured: Change from baseline to immediatly post-treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Why it stopped: decided to shift to a new design and measures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will take part in a baseline assessment, then all will be assigned to time-restricted eating.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105294
- Sponsor's protocol ID
- 2022-10-15725
- Status last verified
- Oct 2023
- First submitted
- 6 Feb 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available at OSF post-study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating as an Adjunctive Intervention for Bipolar Disorder: Acceptability and Feasibility
- ClinicalTrials.gov ID
- NCT06105294
- Acronym / sponsor ID
- 2022-10-15725
- Conditions
- Bipolar Disorder
- Keywords
- eating, circadian
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decided to shift to a new design and measures
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.
Detailed description
Time-restricted eating (TRE) is a way of scheduling food intake that has been shown to improve circadian rhythms in animals and humans. TRE is based on animal and human science that shows that the timing of eating powerfully influences diurnal rhythms. Animal research has shown that feeding during sleep periods leads to a surge of norepinephrine, cortisol, wakefulness, and activity. Drawing on this, over a decade of studies have examined the impact of experimentally randomizing mice to time-restricted feeding during wake hours (vs. 24-hour ad libitum feeding). Importantly, caloric intake and other facets of diet were yoked for strict control. A consistent finding is that TRE had powerful benefits for circadian and metabolic indicators across studies,and more recent data also shows benefit for animal longevity.
Here, the investigators' goal is to extend this work to bipolar disorder (BD). More specifically, the investigators will gather data to examine the acceptability and feasibility of TRE among those who self-identify with bipolar disorder and who experience some problems with sleep, circadian rhythms, or schedules. The investigators will gather measures of mania, depression, sleep, and QOL, to provide preliminary evidence of change on these dimensions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will take part in a baseline assessment, then all will be assigned to time-restricted eating.
| Arm | Type | Receives |
|---|---|---|
| time-restricted eating | Experimental | Behavioral: time-restricted eatingPost-baseline, participants will be asked to restrict their eating to a 10-hour window. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
- Experiencing schedule/sleep or circadian problem in the past 3 months
- Medication regimens stable for past month
- Adequate English language skills for taking part in the program.
- Living in California.
Key exclusion criteria (11 listed)
- Cognitive deficits (Screening OMC Test)
- Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)
- High scores (> 5) on the Screening Eating Disorder Examination Questionnaire
- Current shift work
- >5 kg weight change within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| time-restricted eatingRestrict eating to a 10-hour window. | Behavioural | time-restricted eating |
Primary outcome
Acceptability as assessed using self-ratings on items designed for this study
Time frame: Immediately post-treatment (10 weeks)
self-ratings of the acceptability of the intervention
Feasibility as assessed by percent of clients who complete the assessments and intervention
Time frame: Immediately post-treatment (10 weeks)
Percentage of clients who do not drop out of the trial. Drop out would be defined as not completing the TRE intervention, or failing to complete the end-of-treatment intervention.
4 secondary outcomes
Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9
Time frame: Change from baseline to immediately post-treatment (10 weeks)
Lower Depression symptoms as assessed with the Patient Health Questionnaire-9
Time frame: Change from baseline to immediately post-treatment (10 weeks)
Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales
Time frame: Change from baseline to immediately post-treatment (10 weeks)
higher scores on Self-rated Quality of Life
Time frame: Change from baseline to immediatly post-treatment (10 weeks)
Results and safety
The study was stopped early (reason given: decided to shift to a new design and measures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- link to study team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be available at OSF post-study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time-restricted eating in people with Bipolar Disorder, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: decided to shift to a new design and measures). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as assessed using self-ratings on items designed for this study (time frame: Immediately post-treatment (10 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.