Time-Restricted Eating and Bipolar Disorder

• Sponsor: University of California, Berkeley (Other)
• Overall Status: Terminated
• CT.gov ID: NCT06105294
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Behavioral: time-restricted eating	N/A

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

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Participants will take part in a baseline assessment, then all will be assigned to time-restricted eating.Participants will take part in a baseline assessment, then all will be assigned to time-restricted eating.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Time-Restricted Eating as an Adjunctive Intervention for Bipolar Disorder: Acceptability and Feasibility
• Actual Study Start Date: Jun 1, 2023
• Actual Primary Completion Date: Jul 31, 2023
• Actual Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: time-restricted eating Post-baseline, participants will be asked to restrict their eating to a 10-hour window.	Behavioral: time-restricted eating; Restrict eating to a 10-hour window.

Outcome Measures

Primary Outcome Measures

1. Acceptability as assessed using self-ratings on items designed for this study [Immediately post-treatment (10 weeks)]

   self-ratings of the acceptability of the intervention

2. Feasibility as assessed by percent of clients who complete the assessments and intervention [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.

Secondary Outcome Measures

1. Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9 [Change from baseline to immediately post-treatment (10 weeks)]

   Self-Rated Patient Mania Questionnaire-9

2. Lower Depression symptoms as assessed with the Patient Health Questionnaire-9 [Change from baseline to immediately post-treatment (10 weeks)]

   PHQ-9

3. Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales [Change from baseline to immediately post-treatment (10 weeks)]

   PROMIS self-report of sleep disturbance and sleep-related impairment (summed together)

4. higher scores on Self-rated Quality of Life [Change from baseline to immediatly post-treatment (10 weeks)]

   Brief Quality of Life in Bipolar Disorder scale

Other Outcome Measures

1. Higher Functional impairment on the World Health Organization Disability Assessment Schedule (WHO-DAS2.0) [Change from baseline to immediatly post-treatment (10 weeks)]

   WHO-DAS2.0 nonphysical health-related scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	Berkeley	California	United States	94720

Sponsors and Collaborators

• University of California, Berkeley

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• link to study team website

Publications

None provided.

• Responsible Party: University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT06105294
• Other Study ID Numbers: 2022-10-15725
• First Posted: Oct 27, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, Berkeley: eating; circadian
• Additional relevant MeSH terms: Bipolar Disorder

Study Results

No Results Posted as of Oct 27, 2023