Healthy Lifestyles for Bipolar Disorder

Time Restricted Eating Clinical Trial

— HL  

Official title:

Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06188754
• Other study ID #: Healthy Lifestyles 01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: January 31, 2029

Study information

• Verified date: April 2024
• Source: University of California, Berkeley
• Contact: Sheri L Johnson, PhD
• Phone: (510) 519-4305
• Email: calmprogram[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators will conduct a randomized controlled trial (RCT) to examine the effects of time-restricted eating as compared to the mediterranean diet. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. In the mediterranean diet, participants will be asked to follow a food plan that emphasizes vegetables, fruit, whole grains, and olive oil as central dietary components. The investigators aim to test both food plans as additions to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be randomly assigned to TRE or the mediterranean diet for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the end of treatment and at 3, 6 and 12 months after the intervention. If successful, this work will provide a novel, easily implemented and highly acceptable intervention for BD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

• 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 Mini International Neuropsychiatric Interview; MINI), 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 MINI interview of symptoms during adulthood)

• Past 3-month alcohol use disorder or substance use disorder (assessed by MINI)

• 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

• 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 Orientation Memory Concentration Test (OMC < 9)

Related Conditions & MeSH terms

• Bipolar Disorder
• Diet, Mediterranean
• Time Restricted Eating

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California	Berkeley	California

Sponsors (7)

Lead Sponsor	Collaborator
University of California, Berkeley	Deakin University, Salk Institute for Biological Studies, Swinburne University of Technology, University College, London, University of British Columbia, Wellcome Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.	immediately post-treatment (10 weeks after enrollment)
Primary	Adherence to time-restricted eating	Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.	Average number of daily food logs showing adherence across the 8-week intervention
Primary	Adherence to Mediterranean Diet	Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.	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)
Primary	Mania	Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater	Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Primary	Depression	Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater	Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Primary	Self-rated Quality of Life (QOL)	Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 3-months post intervention as compared to baseline	Scores at 3-months post-intervention (22 weeks after study entry) as compared to baseline
Primary	Mania at follow-up	Sustained lower YMRS scores across follow-up	YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
Primary	Depression at follow-up	Sustained lower MADRS scores across follow-up	MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
Primary	QOL at follow-up	Sustained higher QOL.BD scores	QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline
Secondary	Self-rated mania	Lower Patient Health Questionnaire (PHQ) Mania scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention	at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
Secondary	Self-rated depression	Lower Patient Health Questionnaire (PHQ) Depression scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention	at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
Secondary	Sleep hygiene behaviors	Lower scores on the Sleep Household Environment and In-Bed Behaviors at end-of-treatment (10 weeks) as compared to baseline	post-intervention (10 weeks) as compared to baseline
Secondary	Weekly change in mania severity	Lower Longitudinal Interval Follow-up Evaluation (LIFE) weekly Mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 3, 6, and 12-months after the intervention, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until one year after the intervention ends.	Weekly scores from the end of the intervention through one-year post-intervention follow-up
Secondary	Sleep disturbance and sleep impairment	Lower scores on the Patient Outcomes Reporting Information System (PROMIS) sleep disturbance and sleep impairment scores at post-treatment (10 weeks) as compared to baseline	post-treatment (10 weeks) as compared to baseline
Secondary	Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)	MCTQ scores will show a smaller proportion of individuals with either early or delayed chronotype (as reflected in standard scoring for the MCTQ) at post-treatment as compared to baseline	post-treatment (10 weeks) as compared to baseline
Secondary	Regularity of daily routines (Brief Social Rhythm Questionnaire)	Lower Brief Social Rhythm Questionnaire scores (less irregularity) at post-treatment as compared to baseline	post-treatment (10 weeks) as compared to baseline
Secondary	Daily emotional lability as assessed using ecological momentary assessment	Lower mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at the mid-point of treatment (6 weeks) as compared to baseline. Participants will be asked to complete negative affect ratings several times per day for 8 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 8 days at baseline and at treatment mid-point.	mid-point of treatment (6 weeks post study entry) as compared to baseline