A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder.
Sheri L Johnson, Greg Murray, Emily N C Manoogian...
https://pubmed.ncbi.nlm.nih.gov/39434066/Actively Recruiting
Led by University of California, Berkeley · Updated on 2026-01-14
150
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating how sticking to a time-restricted eating TRE plan affects daily biological rhythms, mood symptoms, and quality of life in adults with bipolar disorder who are already receiving medication treatment. The study aims to understand how changes in the bodys internal clock, measured by gene activity, relate to improvements in mania and depression symptoms, even when considering changes in glucose tolerance and inflammation. This research focuses on people with bipolar disorder who experience sleep or circadian rhythm difficulties. Participants will follow a TRE plan where they limit their eating to a 10-hour window each day for eight weeks, alongside their usual medication. Initially, they will receive an introduction to TRE and then get brief online education several times per week, with optional weekly coaching. If their baseline eating window is longer than 14 hours, they will first reduce it to 12 hours in week one, then to 10 hours in week two. Participants choose their 10-hour eating period based on their usual sleep, family, and social schedules. During the eating window, there are no restrictions on food type or amount, and participants are encouraged to maintain their usual calorie intake. During the study, participants will complete daily records of eating, sleep, and mood for two weeks before starting TRE. They will have assessments of mania, depression, and quality of life at the start, midpoint, end of the 8-week TRE period, and again 3 months later. Researchers will monitor symptom changes, daily emotional fluctuations, and adherence to the eating schedule. The total study participation includes baseline tracking, 8 weeks of TRE, and follow-up assessments up to 16 weeks after starting.
CONDITIONS
Healthy Lifestyles in Bipolar Disorder: Bay Area Study
S
Sheri L Johnson, PhD
N
Nandini A Rajgopal, BS
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University of California, Berkeley
Lead Sponsor
Salk Institute for Biological Studies
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Time‑Restricted Eating (10‑hour window) | Mediterranean‑style Diet (context) |
|---|---|---|
| What it is | A behavioural regimen limiting daily food intake to a 10‑hour window for 8 weeks | A healthful dietary pattern emphasizing plant‑based foods, healthy fats, lean proteins, and whole grains |
| Role in the study | Investigators evaluate TRE as the sole behavioural intervention | Represents a plausible external behavioural comparator though not randomized within the trial |
| Purpose or use | To assess whether restricting eating window can reduce mood symptom severity and improve quality of life and circadian regulation | Often advised to support mood stability, metabolic regulation, and overall well‑being |
| How it is performed | Participants self‑administer TRE by restricting eating to a consistent daily 10‑hour window for 8 weeks, with dietary logs and coaching support | Adopted via self‑directed or coached adherence to balanced dietary choices over similar period |
| Evidence status | Investigational; trial is underway to assess impact on mood, quality of life, and sleep/circadian outcomes | Supported by broader lifestyle literature showing potential mood and functioning benefits in bipolar disorder |
| Important risks | Potential fasting‑related risks (e.g. for those on medications needing food timing such as glucose‑lowering drugs), not fully established within study | Generally low‑risk healthy eating pattern |
| Important limitations | Single‑group design without randomized control limits definitive conclusions about comparative effectiveness | Evidence is drawn from combined lifestyle interventions so specific benefits of Mediterranean diet alone in bipolar disorder are uncertain |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants follow time-restricted eating by limiting their food intake to a 10-hour window each day for 8 weeks, alongside standard medication for bipolar disorder. They receive brief online psychoeducation several times per week with optional weekly coaching sessions.
Several online sessions per week with optional weekly coaching
Duration - 3 months post-intervention
Participants complete assessments of symptoms and quality of life at the mid-point and end of treatment, and again at 3 months post-intervention to monitor changes after the time-restricted eating period.
3 follow-up assessments (online or in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Sheri L Johnson, Greg Murray, Emily N C Manoogian...
https://pubmed.ncbi.nlm.nih.gov/39434066/University of California, Berkeley
Lead Sponsor
Salk Institute for Biological Studies
Collaborating Sponsor