Recruiting

8-TRE

Sponsor:

Massachusetts General Hospital

Code:

NCT07211217

Conditions

Bipolar Disorder (BD)

Bipolar Disorder Depression

Overweight (BMI > 30)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Time Restricted Eating

Study Details

Brief summary:

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.

Conditions

Bipolar Disorder (BD)

Bipolar Disorder Depression

Overweight (BMI > 30)

Study ID

NCT07211217

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (aged 18-65 years)
  • Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21
  • Currently experiencing depression (i.e., PHQ-9 ≥ 10)22
  • Currently overweight (i.e., Body mass index (BMI) > 30 kg/m2)
  • Provides Informed Consent

Exclusion Criteria:

1. Dietary factors:

1. Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)
2. Concurrent dietary intervention or modification unrelated to study procedures
2. Psychiatric factors:

1. Severe depression (i.e., PHQ-9>20)
2. Experiencing manic symptoms (i.e., ASRM < 6)23
3. Active suicidal ideation (i.e., PHQ-9, item 9 >2)
4. Current alcohol/substance use disorder (as assessed with the Quick SCID)
3. Medical factors:

1. Use of weight loss medications or supplements
2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
3. Previous weight loss surgery
4. Malignancy within past 2 years
5. Major surgery within past 3 months
6. Medical instability considered to interfere with study procedures
7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
8. Undergoing treatment for cancer
9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.
4. Lifestyle and other factors:

a. Work or social schedules that would impede ability to adhere to study protocol
5. Adherence factors:

1. Ability to adhere to study procedures

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Time Restricted Eating

See arms description

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Giuliana M Chau

16176439923gchau1@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Giuliana Chau

617-643-9923gchau1@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Time Restricted Eating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-15.