(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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured 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, like clozapine and glucose-lowering medications, are not allowed if they are contraindicated for fasting.

What data supports the effectiveness of the treatment Time-restricted eating for Bipolar Disorder?

Research on time-restricted eating (TRE) shows it can help with weight loss and improve blood sugar levels in people with obesity, but there is no direct evidence yet on its effectiveness for treating bipolar disorder. ^{1 2 3 4 5}

Is intermittent fasting safe for humans?

Research suggests that time-restricted feeding (eating within a specific time window) is generally safe for adults, including those with obesity, as it did not lead to increased adverse events or disordered eating patterns in studies. ^{1 6 7 8 9}

How does time-restricted eating differ from other treatments for bipolar disorder?

Time-restricted eating (TRE) is unique because it focuses on limiting food intake to specific hours of the day, which may help improve metabolic health and potentially influence mood disorders like bipolar disorder. Unlike traditional medications for bipolar disorder, TRE is a dietary approach that may also offer benefits for weight management and metabolic health. ^{1 2 4 10 11}

Research Team

Sheri L Johnson, PhD

Principal Investigator

University of California, Berkeley

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2021]

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

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

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

Intermittent fasting implementation and association with eating disorder symptomatology. [2022]

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

Intermittent fasting: Describing engagement and associations with eating disorder behaviors and psychopathology among Canadian adolescents and young adults. [2022]

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

Intermittent food restriction in female rats induces SREBP high expression in hypothalamus and immediately postfasting hyperphagia. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

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

Time-restricted feeding plus resistance training in active females: a randomized trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

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

Does intermittent fasting impact mental disorders? A systematic review with meta-analysis. [2023]

11. United States 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. [2021]