(Bay Area Study) Intermittent Fasting for Bipolar Disorder

Overseen By Nandini A 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: Depression, eating disorder, substance use, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if time-restricted eating (TRE) can improve daily rhythms and reduce mood swings in people with bipolar disorder. Participants will eat within a 10-hour window each day for eight weeks while tracking their mood, sleep, and eating habits. The study targets individuals already on stable medication for bipolar disorder who currently eat for 12 or more hours a day at least twice a week. As an unphased trial, it offers a unique opportunity to explore innovative lifestyle changes that might enhance well-being.

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, like clozapine and glucose-lowering medications, are not allowed if they are contraindicated for fasting.

What prior data suggests that time-restricted eating is safe for individuals with bipolar disorder?

Research shows that time-restricted eating (TRE) is generally safe and well-liked. Studies with eating windows of 6 to 10 hours have found that people can follow TRE without much trouble, often experiencing health benefits without major issues. However, one study found that eating in less than 8 hours a day might increase the risk of heart problems. Overall, TRE appears to be a safe choice when the eating window is between 6 and 10 hours. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for bipolar disorder, which often involve medications like mood stabilizers and antipsychotics, time-restricted eating (TRE) offers a unique, non-pharmacological approach. TRE is distinctive because it focuses on the timing of food intake rather than the type or quantity, aligning eating patterns with the body’s natural circadian rhythms. Researchers are excited about TRE because it might help stabilize mood by optimizing metabolic processes and reducing inflammation without the side effects associated with medication. Additionally, TRE is flexible and can be easily integrated into daily life, potentially offering a sustainable lifestyle change for individuals with bipolar disorder.

What evidence suggests that time-restricted eating might be an effective treatment for bipolar disorder?

Research has shown that time-restricted eating (TRE), which participants in this trial will follow, might help people with bipolar disorder by boosting mood and health. One study found that TRE aids in weight control and improves metabolic health, which can influence mood stability. Another study suggested that TRE might help align the body's internal clock, possibly reducing symptoms of mania and depression. Early findings also indicate that TRE can enhance thinking and mood. While more research is needed, these initial results are promising for using TRE as an additional treatment for bipolar disorder. ^{6 7 8 9 10}

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 I or II disorder, who speak English and have been on a stable mood-stabilizing medication regimen for at least one month. They should not have had significant weight changes recently, eat over a 12-hour period regularly, and can use a phone camera and web surveys. People with sleep disorders or those doing shift work that disrupts sleep are excluded.

Inclusion Criteria

I am currently receiving treatment for bipolar disorder.

I have sleep problems or my sleep schedule is irregular.

I have been speaking English for 10+ years or can understand it well for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

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

2 weeks

Daily self-reports

Treatment

Participants follow time-restricted eating (TRE) for 8 weeks, with online psychoeducation and optional weekly coaching

8 weeks

Several online sessions per week

Follow-up

Participants are monitored for changes in symptoms and quality of life post-intervention

3 months

Assessments at 1.5 and 3 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating

Trial Overview The study tests if following an 8-week time-restricted eating plan affects the body's natural rhythms and if these changes can improve mania and depression symptoms in people with bipolar disorder. Participants will also track their eating, sleep, mood daily before starting TRE.

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.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

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+

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+

Published Research Related to This Trial

Intermittent fasting (IF) has a moderate positive effect on reducing depression scores, based on a systematic review of 14 studies involving 562 individuals, with a standardized mean difference of 0.41 compared to control groups.

IF did not show significant effects on anxiety or mood states, indicating that while it may help with depression, it does not negatively impact mental health and is safe for the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intermittent fasting impact mental disorders? A systematic review with meta-analysis. Fernández-Rodríguez, R., Martínez-Vizcaíno, V., Mesas, AE., et al.[2023]

Time-restricted eating (TRE) significantly reduces body weight and fat mass, with an average weight loss of 1.60 kg and fat loss of 1.48 kg in a meta-analysis of 17 studies involving 899 participants.

TRE particularly benefits overweight individuals, leading to improvements in lipid profiles, including lower triglycerides, total cholesterol, and LDL cholesterol, although it does not significantly affect waist circumference or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Liu, L., Chen, W., Wu, D., et al.[2022]

Intermittent fasting (IF) led to greater weight and body fat loss compared to calorie restriction (CR) in a study of 46 healthy women with overweight or obesity, suggesting that IF may be a more effective short-term weight loss strategy.

Despite the differences in weight loss, both IF and CR did not significantly affect perceived eating behaviors, mood, sleep quality, or cognitive performance, indicating that IF is a safe alternative to CR without negative impacts on psychological or cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight weeks of intermittent fasting versus calorie restriction does not alter eating behaviors, mood, sleep quality, quality of life and cognitive performance in women with overweight. Teong, XT., Hutchison, AT., Liu, B., et al.[2021]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

In a study of 2762 Canadian adolescents and young adults, nearly half of the participants reported engaging in intermittent fasting, with the highest prevalence among transgender/gender non-conforming individuals (52.0%).

Intermittent fasting was significantly linked to eating disorder behaviors and psychopathology, particularly among women, highlighting the need for further research and public health initiatives to address potential risks associated with this dietary practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting: Describing engagement and associations with eating disorder behaviors and psychopathology among Canadian adolescents and young adults. Ganson, KT., Cuccolo, K., Hallward, L., et al.[2022]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

Intermittent food restriction (IFR) in female Wistar rats led to increased expression of lipogenic proteins SREBP-1c and SREBP-2 in the hypothalamus, which may influence fat storage and metabolism.

Both treatment groups exhibited overeating immediately after fasting, indicating that IFR could lead to hyperglycemia and potential risks for diabetes and weight regain after the restriction period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent food restriction in female rats induces SREBP high expression in hypothalamus and immediately postfasting hyperphagia. Rosas Fernández, MA., Concha Vilca, CM., Batista, LO., et al.[2019]

Intermittent fasting through time-restricted feeding (TRF) did not hinder muscle growth or performance in resistance-trained females, showing that similar gains can be achieved regardless of feeding schedule, as long as energy and protein intake are maintained.

Participants on TRF experienced a significant reduction in fat mass compared to those on a control diet, suggesting that TRF may be beneficial for fat loss without compromising muscle adaptations during resistance training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding plus resistance training in active females: a randomized trial. Tinsley, GM., Moore, ML., Graybeal, AJ., et al.[2023]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

Intermittent fasting (IF) participants, consisting of 44 women and 20 men, reported higher levels of eating disorder (ED) symptomatology compared to community norms, with 31.25% scoring at or above the clinical cutoff on the Eating Disorder Examination Questionnaire (EDE-Q).

The study indicates a concerning association between IF and ED behaviors, suggesting that individuals engaging in IF may be at risk for developing or exhibiting disordered eating patterns, highlighting the need for further research on this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting implementation and association with eating disorder symptomatology. Cuccolo, K., Kramer, R., Petros, T., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07211217

Time Restricted Eating (TRE) in Bipolar Disorder The overall goal of this study is to examine the effects of TRE on weight loss and secondary health outcomes in individuals with BD,. A ...

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

A randomized controlled trial to compare the effects of time ... The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06157-5

A pre-post trial to examine biological mechanisms of the ... The primary objective of this trial is to examine the mechanisms of time-restricted eating (TRE) as an adjunct to psychiatric care for people with bipolar ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0271531725000454?dgcid=rss_sd_all

Comparing the effectiveness of calorie restriction with and ... Time-restricted eating (TRE) may extend the cardiometabolic health benefits of calorie restriction (CR). •. Few studies have compared the effects of CR with and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10647529/

Intermittent Fasting as a Potential Therapeutic Instrument for ... Recent studies have reported positive effects of Intermittent Fasting (IF) on metabolic parameters, cognition, and mood.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111287/

Time-restricted eating: What we know and where the field is ... Trials with an eating window of 6 to 10 hours found that TRE was generally safe and well received and that it had a variety of health benefits. Health benefits ...

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

A randomized controlled trial to compare the effects of time ... The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002799

Effect of time restricted eating versus current practice in ... Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04000516?term=AREA%5BConditionSearch%5D(Time%20Restricted%20Feeding)&rank=1

The Effects of Early and Late Time-Restricted Feeding on ... Changes in body composition (change in weight, percent body fat percent, and percent lean body mass) are the primary outcome, and hunger and satiety ratings and ...

10. newsroom.heart.org newsroom.heart.org/news/8-hour-time-restricted-eating-linked-to-a-91-higher-risk-of-cardiovascular-death

8-hour time-restricted eating linked to a 91% higher risk of ... People who followed a pattern of eating all of their food across less than 8 hours per day had a 91% higher risk of death due to cardiovascular ...