Time Restricted Eating (TRE) in Bipolar Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07211217
Status
Recruiting
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Conditions

  • Bipolar Disorder (BD)
  • Bipolar Disorder Depression
  • Overweight (BMI > 30)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Time Restricted Eating — OTHER
    See arms description

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Time Restrictive Eating Condition
    TRE is a dietary intervention where participants eat all of their food within a specific 8-hour eating window, for example eating only between 10am and 6pm. Participants will not be asked to change what they eat, only when to eat. Participants will keep a daily Food Timing Log to record the time of the first and last food and drink that they consume each day. The study will ask participants to continue to do this daily throughout the study (\~8 weeks).
  • No Intervention: Waitlist Condition
    Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.

Primary Outcome Measure

Weight Loss [ Time Frame: Week 0, Week 8, Week 20 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Giuliana Chau
[email protected]
617-643-9923

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By research site
Massachusetts General Hospital· Boston, MA

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