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Behavioural Intervention

Time Restricted Eating (TRE) for 8 weeks for Intermittent Fasting (HL Trial)

N/A

Waitlist Available

Led By Sheri L Johnson, PhD

Research Sponsored by University of California, Berkeley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

< 5 kg weight change in the past 3 months

Meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly scores from the end of the intervention through one-year post-intervention follow-up

Awards & highlights

HL Trial Summary

This trial aims to compare the effects of two different healthy lifestyles on people with bipolar disorder. The trial will investigate the acceptability of time-restricted eating and the Mediterranean diet for those who are already taking

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on dietary interventions rather than medications, side effects may include changes in weight, digestive discomfort or alterations in energy levels due to new eating patterns.

HL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight has been stable, changing less than 5 kg in the last 3 months.

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I have been diagnosed with bipolar I or II disorder.

HL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly scores from the end of the intervention through one-year post-intervention follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly scores from the end of the intervention through one-year post-intervention follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly scores from the end of the intervention through one-year post-intervention follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Adherence to Mediterranean Diet

Adherence to time-restricted eating

+6 more

Secondary outcome measures

Daily emotional lability as assessed using ecological momentary assessment

Regularity of daily routines (Brief Social Rhythm Questionnaire)

Self-rated depression

+5 more

HL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time Restricted Eating (TRE) for 8 weeksExperimental Treatment1 Intervention

Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief blogs several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day. To do so, people typically avoid eating in the first 1-2 hours after they wake up 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 time period, the investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules. The investigators will review 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 weeksActive Control1 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 blogs 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 16 countries that border the Mediterranean Sea. 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time restricted eating

2021

N/A

~130

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Swinburne University of TechnologyOTHER

20 Previous Clinical Trials

7,386 Total Patients Enrolled

Deakin UniversityOTHER

31 Previous Clinical Trials

20,755 Total Patients Enrolled

University of California, BerkeleyLead Sponsor

180 Previous Clinical Trials

720,886 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals such as myself participate in this clinical study?

"To be considered eligible for enrollment in this study, potential participants must adhere to a Mediterranean diet and fall within the age range of 18 to 65. The trial aims to recruit approximately 300 individuals."

Answered by AI

Is the inclusion criteria for this study limited to individuals above the age of 25?

"To meet the eligibility requirements for participation in this clinical trial, prospective participants must be at least 18 years old and no older than 65."

Answered by AI

Is the enrollment for this study currently available to prospective participants?

"Based on the information available on clinicaltrials.gov, this particular clinical trial is not currently accepting new participants. The trial was first listed on January 31st, 2024 and its most recent update was made on December 18th, 2023. However, it's worth noting that there are presently a total of 168 other ongoing studies actively seeking eligible candidates for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Healthy Lifestyles for Bipolar Disorder

2024. "Healthy Lifestyles for Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188754.

All > Bipolar Disorder