Time-Restricted Eating and Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Time-Restricted Eating as an Adjunctive Intervention for Bipolar Disorder: Acceptability and Feasibility

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06105294
• Other study ID #: 2022-10-15725
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• time-restricted eating
Restrict eating to a 10-hour window.

Locations

Country	Name	City	State
United States	University of California	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Higher Functional impairment on the World Health Organization Disability Assessment Schedule (WHO-DAS2.0)	WHO-DAS2.0 nonphysical health-related scales	Change from baseline to immediatly post-treatment (10 weeks)
Primary	Acceptability as assessed using self-ratings on items designed for this study	self-ratings of the acceptability of the intervention	Immediately post-treatment (10 weeks)
Primary	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.	Immediately post-treatment (10 weeks)
Secondary	Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9	Self-Rated Patient Mania Questionnaire-9	Change from baseline to immediately post-treatment (10 weeks)
Secondary	Lower Depression symptoms as assessed with the Patient Health Questionnaire-9	PHQ-9	Change from baseline to immediately post-treatment (10 weeks)
Secondary	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)	Change from baseline to immediately post-treatment (10 weeks)
Secondary	higher scores on Self-rated Quality of Life	Brief Quality of Life in Bipolar Disorder scale	Change from baseline to immediatly post-treatment (10 weeks)

External Links

•   link to study team website