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Time Restricted Eating (TRE) in Bipolar Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 1 week

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eating only during a set time each day improves how the body uses food and the amount of body fat and muscle. It is for adults with bipolar disorder, obesity, and current depression. People are assigned by chance to follow the eating plan for 8 weeks or join a waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 65.
  • Diagnosed with bipolar I or II disorder.
  • Currently depressed, with a score of at least 10 on the PHQ-9 depression survey.
  • Have a body mass index (BMI) above 30. BMI is a measure based on height and weight.
  • Agree to join after learning about the study.

Who can't join

  • Have a known or strongly suspected eating disorder, or are following another diet plan or making diet changes outside the study.
  • Have severe depression (PHQ-9 score above 20), symptoms of mania (unusually high energy or mood), or active thoughts of suicide.
  • Currently have an alcohol or drug use disorder.
  • Use weight-loss drugs or supplements, or medicines that can change weight unless both weight and medicine use have been stable for at least 6 months.
  • Have had weight-loss surgery, cancer within the past 2 years, or major surgery within the past 3 months; are receiving cancer treatment; or have unstable health that could interfere with the study.
  • Use medicines that can cause low blood sugar, such as insulin, or medicines whose food timing needs would conflict with the eating plan.
  • Have work or social schedules that would prevent following the study plan.
  • The listing also names the ability to follow study steps as an exclusion, but it is unclear what this means.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA