40 Participants NeededMy employer runs this trial

Time Restricted Eating for Bipolar Depression

JY
GS
DR
Overseen ByDeniz Ruscuklu, BA
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (TRE) can alleviate symptoms of bipolar disorder, particularly mood disruptions. Participants will be divided into two groups: one will follow TRE by eating within a 10-hour window each day, while the other will receive nutritional counseling. The goal is to determine if TRE serves as a practical and beneficial addition to standard bipolar treatments. The trial may suit individuals diagnosed with bipolar I or II disorder who are currently experiencing depression. As an unphased trial, it provides a unique opportunity to investigate innovative approaches to managing bipolar disorder symptoms.

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. However, you cannot participate if you are taking stimulant medications or hypoglycemia-inducing medications.

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

Research has shown that time-restricted eating (TRE) is generally safe and popular. In other studies, participants have tried eating within 6 to 10-hour windows, and most find it easy to follow. Although specific studies on TRE for mood disorders like bipolar disorder are lacking, it has been tested in other health areas with positive safety outcomes. TRE alters only the timing of meals, not the content, avoiding new medications or complex treatments. This simplicity makes it a promising and low-risk option to try alongside usual treatments.12345

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for bipolar depression because it offers a novel approach that differs from traditional treatments like mood stabilizers and psychotherapy. Unlike these standard options, TRE focuses on when you eat, not just what you eat or how it's treated medically. By limiting food intake to a specific 10-hour window each day, TRE may help regulate biological rhythms and mood stability without altering medication regimens. This method is non-invasive and could offer an additional tool alongside existing treatments to improve quality of life for individuals with bipolar depression.

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

This trial will compare time-restricted eating (TRE) with eating ad libitum for individuals with bipolar depression. Studies have shown that TRE can improve mood and reduce mood swings in people with bipolar disorder. Research suggests that TRE might help by stabilizing daily routines, which are often disrupted in those with bipolar disorder. One study found that TRE led to significant improvements in tiredness and physical health. Although specific studies on mood disorders are still underway, these early findings indicate that TRE could be a promising way to support overall well-being in bipolar disorder.12346

Who Is on the Research Team?

GS

Gayatri Saraf, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for adults with bipolar I or II disorder who currently have mild to moderate depression. Participants must be able to read and write in English or French, use email and a smartphone app, provide consent, and (if female) use effective birth control during the study.

Inclusion Criteria

I can speak, read, write, and understand English or French.
I can use email and a smartphone app for the trial period.
I am willing to use email for study-related activities.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Participants complete baseline assessments including questionnaires and blood samples

1 week
1 visit (in-person)

Treatment

Participants undergo an 8-week intervention with either time-restricted eating or nutritional counselling

8 weeks
Weekly phone check-ins, 1 visit (in-person) at week 4

Follow-up

Participants are monitored for adherence and outcomes post-intervention

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Time restricted eating

Trial Overview

The study compares two approaches: time-restricted eating (eating all meals within a chosen 10-hour window each day) versus regular nutritional counselling. Both groups continue their usual care for bipolar disorder over an 8-week period.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group 2:Time-restricted eating plus treatment as usualExperimental Treatment1 Intervention
Group II: Group 1: Eating ad libitum, nutritional counselling plus treatment as usualExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials
231
Recruited
267,000+

Ottawa Hospital Research Institute

Collaborator

Trials
585
Recruited
3,283,000+

Citations

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 secondary goal is to ...

A pre-post trial to examine biological mechanisms of the ...

A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder.

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38762486/

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 ...

(Bay Area Study) Intermittent Fasting for Bipolar Disorder

This trial aims to determine if time-restricted eating (TRE) can improve daily rhythms and reduce mood swings in people with bipolar disorder.

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.