(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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.

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 the Mediterranean diet safe for humans?

The Mediterranean diet is generally considered safe and is linked to health benefits, including improved heart health and reduced risk of some cancers. It emphasizes plant-based foods, healthy fats, and moderate wine consumption, and has been shown to have positive effects on metabolic health. ^{1 2 3 4 5}

How does the Mediterranean diet and time-restricted eating treatment differ from other treatments for bipolar disorder?

This treatment is unique because it focuses on improving diet quality and eating patterns, which may help reduce the severity of bipolar disorder symptoms by addressing unhealthy lifestyle factors that are linked to worse illness outcomes. Unlike traditional medications, this approach uses dietary changes and time-restricted eating to potentially improve both physical and mental health. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Mediterranean diet, Mediterranean-style diet, Mediterranean dietary pattern, Time restricted eating, Time-Restricted Feeding, Intermittent Fasting, 16:8 Diet, 8-Hour Eating Window for bipolar disorder?

Research shows that lifestyle interventions, including diet and physical activity, can significantly improve depressive symptoms and functioning in people with bipolar disorder. Improving diet quality may also enhance overall health and psychiatric outcomes for these patients. ^{6 10 11 12 13}

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. United States pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for bipolar disorders: A systematic review and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evening chronotype, disordered eating behavior, and poor dietary habits in bipolar disorder. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Nutrition and Bipolar Depression. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Diet quality and eating patterns in euthymic bipolar patients. [2020]

5. Denmark 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Mediterranean diet and the metabolic syndrome: the end of the beginning. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Healthy traditional Mediterranean diet: an expression of culture, history, and lifestyle. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Association between the adherence to the Mediterranean dietary pattern and common mental disorders among community-dwelling elders: 2015 Health Survey of São Paulo, SP, Brazil. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet and Cancer: What Do Human and Molecular Studies Have to Say about It? [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A Mediterranean-style eating pattern with lean, unprocessed red meat has cardiometabolic benefits for adults who are overweight or obese in a randomized, crossover, controlled feeding trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A qualitative study investigating bipolar patients' expectations of a lifestyle intervention: A self-management program. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Lifestyle characteristics of psychiatric outpatients. [2019]

13. Ireland pubmed.ncbi.nlm.nih.gov

The relationship between lifestyle factors and clinical symptoms of bipolar disorder patients in a Chinese population. [2022]