Time Restricted Eating (TRE) in Bipolar Disorder

This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.

NCT Number	NCT07211217
Lead Sponsor	Massachusetts General Hospital Collaborators: Brigham and Women's Hospital
Conditions	Bipolar Disorder (BD), Bipolar Disorder Depression, Overweight (BMI > 30)
Enrollment	40 participants
Start Date	2026-06-15
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-15