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Led by University of California, Berkeley · Updated on 2026-08-04
300
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are conducting a clinical trial to compare the effects of two healthy lifestyle approachestime-restricted eating TRE and the Mediterranean dieton individuals with bipolar disorder who are already receiving medication treatment. The study aims to understand how acceptable each diet is and how they influence manic and depressive symptoms as well as quality of life over time. Participants will first complete daily records of eating, sleep, and mood for two weeks. Then, they will be randomly assigned to either follow TRE, limiting food intake to a 10-hour daily window, or the Mediterranean diet, which emphasizes vegetables, fruits, whole grains, olive oil, and lean protein sources, for eight weeks. Both groups receive online psychoeducation and optional weekly coaching sessions during the intervention. If successful, these diets may serve as practical additions to standard bipolar disorder treatment. Throughout the study, participants will have their symptoms and quality of life assessed at the start, during, and after the eight-week dietary intervention. Follow-up evaluations will occur at 3, 6, and 12 months post-intervention to monitor lasting effects. Researchers will also track adherence to the diets, sleep patterns, mood changes, and daily routines using questionnaires, food logs, and ecological momentary assessments to better understand treatment impacts and acceptability.
CONDITIONS
Healthy Lifestyles for Bipolar Disorder
S
Sheri L Johnson, PhD
N
Nandini Rajgopal, BS
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University of California, Berkeley
Lead Sponsor
University College, London
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 (TRE): 10-hour daily eating window | Mediterranean Diet: Diet advice emphasizing vegetables, fruits, whole grains, olive oil |
|---|---|---|
| What it is | A behavioral intervention restricting food intake to a 10-hour daily window for 8 weeks. | Dietary counseling to follow a Mediterranean eating pattern, focused on vegetable, fruit, whole grain intake, and olive oil use for 8 weeks. |
| Role in the trial | Investigational intervention arm; tested for effects on mood, sleep, diet adherence, and quality of life. | Active comparator arm; tested for behavioral and clinical effects alongside time restricted eating. |
| Primary use | Aims to improve mood, sleep, and quality of life through structured time-limited eating in adults with bipolar disorder. | Aims to improve mood symptoms, sleep, and quality of life through Mediterranean dietary patterns. |
| How it is given or performed | Participants are instructed to eat all meals and snacks within a self-selected 10-hour daily window, tracked via dietary logs and phone surveys. | Participants receive dietary counseling and follow a Mediterranean-style diet, with adherence tracked using food logs and self-report tools. |
| Evidence status | TRE is an investigational dietary intervention for bipolar disorder. Evidence is limited to ongoing clinical trials and a recent randomized study assessing its impact on mood and sleep. | The Mediterranean diet is an established healthy eating pattern with evidence for general mood and physical health improvement, though its specific effects in bipolar disorder are under active investigation with recent randomized evidence. |
| Important limitations | TRE feasibility may be limited for individuals with complex daily schedules, shift work, or medication requirements outside the eating window. Evidence of long-term effects in bipolar disorder is not yet established. | Adherence to Mediterranean eating may vary based on food access, affordability, and cultural preferences. The precise effects of this diet in bipolar disorder remain under study. |
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.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and baseline visit
Duration - 2 weeks
Participants complete daily measures of eating, sleep, and mood for two weeks before starting the diet plans.
Daily self-reporting
Duration - 8 weeks
Participants are randomly assigned to follow either time-restricted eating or the Mediterranean diet for 8 weeks, receiving online education and optional weekly coaching.
Regular online check-ins and optional coaching sessions
Duration - Up to 12 months
Participants complete symptom and quality of life assessments at the end of treatment and at 3, 6, and 12 months post-intervention to monitor lasting effects.
Several follow-up assessments over one year
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sheri L Johnson, Greg Murray, Lance J Kriegsfeld...
https://pubmed.ncbi.nlm.nih.gov/38762486/University of California, Berkeley
Lead Sponsor
University College, London
Collaborating Sponsor
