Actively Recruiting
Feasibility and Acceptability of Adjunctive Time Restricted Eating Compared to Nutritional Counselling in Bipolar Disorder: A Pilot Randomized Controlled Trial
Led by University of Ottawa · Updated on 2026-05-01
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Ottawa
Lead Sponsor
O
Ottawa Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Bipolar disorders (BD) affect mood, behavior, and thinking, causing significant challenges. This research investigates how disruptions in the body's internal clock, or circadian rhythm, relate to BD symptoms like depression and mania. The study aims to explore whether dietary changes, specifically time restricted eating (TRE), can improve these symptoms and overall health. This pilot study tests TRE's feasibility and acceptability to prepare for a larger trial. Participants will be assigned to one of two groups: one receiving nutritional counseling plus usual treatment, and the other receiving the same counseling plus a 10-hour daily eating window (TRE) for 8 weeks. Both groups will continue their regular medical and psychological treatments without changes. The TRE group will have weekly check-ins to support adherence, and all participants will receive guidance from a registered dietitian. During the study, participants will complete questionnaires about mood, anxiety, sleep, and thinking skills at the start, week 4, and week 8. Blood samples will be collected at the beginning and end to assess inflammation and other health markers. Participants will wear a watch to monitor activity and light exposure continuously. The main focus is on whether people complete and accept the study, with additional measures of mood, sleep quality, cognition, and biological rhythms monitored throughout.
CONDITIONS
Brief Title
SYNCED - SYNChronized Eating in Bipolar Depression Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 55 years old
- Have a confirmed diagnosis of bipolar I or bipolar II disorder
- Have depression symptoms with specific scores on standard mood rating scales
- Females of childbearing potential must agree to use effective contraception during the study
- Able to speak, read, write, and understand English or French
- Willing and able to provide informed consent
You will not qualify if you...
- Presence of catatonic symptoms or eating disorders
- Unstable or inadequately treated neurological or medical conditions
- Prior bariatric surgery
- Taking medications that cause low blood sugar
- Pregnant or breastfeeding
- Currently taking stimulant medications
- Participating in another diet or weight management program during the trial
- Contraindications to fasting as judged by the clinician
- Started structured psychotherapy within the past 8 weeks
- Any other medical condition, substance use disorder, or suicidal thoughts that raise safety concerns
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either time restricted eating instruction with nutritional counselling and treatment as usual, or nutritional counselling plus treatment as usual. Time restricted eating involves consuming all food and beverages (except water) within a consistent 10-hour window daily for 8 weeks. Nutritional counselling includes advice from a registered dietician. Participants continue their usual pharmacological and psychological treatments during this period.
Weekly phone check-ins and 2 in-person visits (baseline and week 4 check-in with dietician)
Duration - Up to 4 weeks after treatment
Participants are monitored for outcomes related to mood, cognition, sleep, and quality of life after the intervention period ends.
1 in-person visit at week 8
Trial Site Locations
Total: 1 location
1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
D
Deniz Ruscuklu, BA
G
Gayatri Saraf, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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