Time Restricted Eating (TRE) in Bipolar Disorder

NCT07211217 | Not Yet Recruiting DMC

• 1 other identifier: 2025P002114
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Time Restricted Eating

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Body weight will be collected in the fasted state using a digital scale (lbs)

  Week 0, Week 8, Week 20

Secondary Outcomes (8)

• Patient Health Questionnaire-9 (PHQ-9)

  Week 0, Week 4, Week 8, Week 20

• Generalized Anxiety Disorder scale (GAD-7)

  Week 0, Week 4, Week 8 and Week 20

• Pittsburgh Sleep Quality Index (PSQI)

  Week 0, Week 4, Week 8, Week 20

• Cognitive complaints in bipolar disorder rating assessment (COBRA)

  Week 0, Week 4, Week 8, Week 20

• Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a

  Week 0, Week 4, Week 8, Week 20

Study Arms (2)

Time Restrictive Eating Condition

ACTIVE COMPARATOR

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).

Other: Time Restricted Eating

Waitlist Condition

NO INTERVENTION

Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.

Interventions

Time Restricted Eating OTHER

See arms description

Time Restrictive Eating Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dietary factors:
• 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)
• Concurrent dietary intervention or modification unrelated to study procedures
• Psychiatric factors:
• Severe depression (i.e., PHQ-9\>20)
• Experiencing manic symptoms (i.e., ASRM \< 6)23
• Active suicidal ideation (i.e., PHQ-9, item 9 \>2)
• Current alcohol/substance use disorder (as assessed with the Quick SCID)
• Medical factors:
• Use of weight loss medications or supplements
• Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
• Previous weight loss surgery
• Malignancy within past 2 years
• Major surgery within past 3 months
• Medical instability considered to interfere with study procedures

Sponsors & Collaborators

• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Bipolar Disorder; Overweight; Intermittent Fasting

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Louisa G. Sylvia, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuliana M Chau

CONTACT

16176439923; gchau1@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Model Details: Waitlist Control Group

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 7, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05