(Online Study) Healthy Lifestyles for Bipolar Disorder

(HL Trial)

Overseen By Nandini Rajgopal, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Must be taking: Mood stabilizers

Must not be taking: Clozapine, glucose-lowering, corticosteroids

Disqualifiers: Current mood episode, eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different healthy eating plans—time-restricted eating and the Mediterranean diet—affect people with bipolar disorder who are already on medication. Researchers aim to determine how these diets influence mood symptoms and overall quality of life. Participants will track their eating, sleep, and mood for two weeks, then follow one of the diets for eight weeks. This trial suits individuals with bipolar I or II disorder who have sleep concerns and are currently stable on their medication. As an unphased trial, it offers a unique opportunity to contribute to understanding how diet can improve life quality for those with bipolar disorder.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your mood-stabilizing medication regimen has been stable for at least one month. Some medications that are contraindicated (not recommended) for fasting, like clozapine and certain diabetes medications, may affect eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the Mediterranean diet and time-restricted eating (TRE) are safe and easy to follow. Studies have found that the Mediterranean diet, which emphasizes fruits, vegetables, whole grains, and healthy fats, can improve heart health and lower the risk of some cancers.

Time-restricted eating, which involves eating only during certain hours each day, is also generally safe. It can enhance metabolism and mood, and many people find it easy to maintain.

Overall, both diets have been studied and found to be safe with positive health benefits. Participants in these studies did not report major issues, making them promising options to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring healthy lifestyle changes like the Mediterranean diet and Time Restricted Eating (TRE) for managing bipolar disorder because they offer a non-pharmacological approach that could complement existing treatments like mood stabilizers and antipsychotics. Unlike the standard medications, which focus on altering brain chemistry, these lifestyle interventions aim to improve overall well-being through natural methods. The Mediterranean diet emphasizes nutrient-rich foods that support brain health, while TRE encourages better eating habits by limiting eating hours, potentially stabilizing mood and energy levels. Together, they represent a promising shift towards holistic management of bipolar disorder, which could enhance quality of life without the side effects often associated with medication.

What evidence suggests that this trial's treatments could be effective for bipolar disorder?

This trial will compare the Mediterranean diet and Time-Restricted Eating (TRE) as interventions for bipolar disorder. Research has shown that the Mediterranean diet, which participants in this trial may follow, can help reduce symptoms of mood disorders, such as bipolar disorder. This diet includes plenty of fruits, vegetables, whole grains, and lean proteins, and it can improve mental health by reducing depression and anxiety. It is also linked to a better overall quality of life.

Time-restricted eating (TRE), another intervention in this trial, involves consuming all meals within a specific 10-hour window each day. Early evidence suggests that TRE can benefit mood and metabolic health. Studies indicate that TRE can help regulate the body's internal clock, which might improve mood stability for people with bipolar disorder. Both the Mediterranean diet and TRE offer promising ways to manage symptoms alongside medication. ^{1 2 6 7 8}

Who Is on the Research Team?

Sheri L Johnson, PhD

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

This trial is for individuals with bipolar disorder who are currently on medication. Participants will track their eating, sleep, and mood for two weeks before being randomly assigned to one of two healthy eating plans: time-restricted eating or the Mediterranean diet.

Inclusion Criteria

My mood-stabilizing medication has been the same for at least a month.

I have not gained or lost more than 11 pounds in the last 3 months.

I have access to a smartphone.

Exclusion Criteria

I have been diagnosed with or treated for an eating disorder.

I am not on medications that can't be taken while fasting, except for semaglutide.

Have you been diagnosed with Schizophrenia?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete daily measures of eating, sleep, and mood for two weeks

2 weeks

Daily self-reports

Treatment

Participants are randomly assigned to either time-restricted eating or the Mediterranean diet for 8 weeks

8 weeks

Weekly online sessions and optional coaching

Post-Treatment Assessment

Participants complete measures of symptoms and Quality of Life at the end of the food plan

2 weeks

End-of-treatment assessments

Follow-up

Participants are monitored for sustained changes in symptoms and Quality of Life at 3, 6, and 12 months post-intervention

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean diet
• Time restricted eating

Trial Overview The study aims to assess the acceptability and impact of time-restricted eating versus the Mediterranean diet on manic and depressive symptoms, as well as overall quality of life in people with bipolar disorder already receiving medication.

How Is the Trial Designed?

Group I: Time Restricted Eating (TRE) for 8 weeks Experimental Treatment 1 Intervention

Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window > 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.

Group II: Mediterranean diet for 8 weeks Active Control 1 Intervention

Participants will receive a several page introduction to the mediterranean diet, and then will receive support throughout the 8 week intervention to follow this food plan, including brief online psychoeducation that will be sent several times per week, and optional weekly coaching sessions. The mediterranean diet is a plan for healthy eating based on how people eat in the mediterranean region. Individuals will be encouraged to consume vegetables (6 servings/day), fruits (2-4 servings/day), whole grains (daily), legumes (3-4 times per week), nuts (.5 oz per day), and oily fish (2 servings/week). Participants will be encouraged to choose lean meats and other sources of protein over red meat and processed meats. Sweets, refined cereals, alcohol, and wine or alcohol will be labelled as extras, and participants will be encouraged to limit consumption of extras.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

Swinburne University of Technology

Collaborator

Trials

22

Recruited

7,900+

Deakin University

Collaborator

Trials

38

Recruited

21,900+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

University College, London

Collaborator

Trials

884

Recruited

38,770,000+

Wellcome Trust

Collaborator

Trials

236

Recruited

15,770,000+

Published Research Related to This Trial

In a study of 783 adults with bipolar disorder, those with an evening chronotype exhibited significantly higher rates of disordered eating behaviors, including binge-eating and bulimia nervosa, as well as poorer dietary habits compared to non-evening types.

The findings suggest that circadian system dysfunction, indicated by evening chronotype, may contribute to unhealthy eating patterns in bipolar disorder patients, highlighting the potential for targeting circadian rhythms in future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evening chronotype, disordered eating behavior, and poor dietary habits in bipolar disorder. Romo-Nava, F., Blom, TJ., Guerdjikova, A., et al.[2021]

A 48-week study involving 82 participants with Bipolar Disorder showed that a high n-3 plus low n-6 dietary intervention (H3-L6) significantly reduced variability in mood symptoms compared to a control diet, suggesting potential benefits for mood stability.

While the H3-L6 diet did not show significant differences in average mood ratings or other symptoms, it effectively altered the levels of n-3 and n-6 fatty acids over time, indicating a possible mechanism for its impact on mood variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive dietary intervention for bipolar disorder: a randomized, controlled, parallel-group, modified double-blinded trial of a high n-3 plus low n-6 diet. Saunders, EFH., Mukherjee, D., Myers, T., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11102174/

A randomized controlled trial to compare the effects of time ... A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6993089/

The Role of Dietary Patterns in Mood Disorders Prospective cohort studies have shown a dose-response relationship between Mediterranean diet patterns and mood disorder symptoms or diagnosis.

3. esmed.org esmed.org/MRA/mra/article/download/5390/99193548045/

The Role of Food and Nutrition in Treating Bipolar Disorder MEDITERRANEAN DIET. A Mediterranean dietary pattern is primarily characterized as a plant-based diet rich in fruits, vegetables, whole grains, ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/fsn3.2950

The relationship between the Mediterranean diet and Axis I ... It seems that the Mediterranean diet can reduce the symptoms or the occurrence of Axis I disorders (especially depression and anxiety).

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724005299

A healthy dietary pattern is associated with microbiota ... A healthier diet was associated with higher diversity and richness of microbiota in recently diagnosed BD patients.

6. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05790-4

A randomized controlled trial to compare the effects of time ... Both TRE and the Mediterranean diet have been found to yield benefits in cardiovascular disease, diabetes, and metabolic parameters across ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7536728/

Mediterranean Diet and its Benefits on Health and Mental Health This narrative review reports on some emerging pieces of evidence on the possible impact of MD on general health and the outcome of psychiatric disorders.

8. withpower.com withpower.com/trial/phase-bipolar-disorder-2024-b3fb7

Healthy Lifestyles for Bipolar Disorder · Info for Participants The Mediterranean diet is generally considered safe and is linked to health benefits, including improved heart health and reduced risk of some cancers. It ...