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Time-Restricted Eating for Coronary Heart Disease (TREat-CR Trial)
N/A
Recruiting
Led By Paul Oh, MD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
TREat-CR Trial Summary
This trial will study the feasibility and safety of using a time-restricted eating diet during cardiac rehabilitation, and if it has any benefits compared to cardiac rehabilitation alone.
Who is the study for?
This trial is for men and women eligible for outpatient cardiac rehabilitation due to coronary artery disease, who are willing to follow the study's procedures. It excludes those with communication barriers, night shift workers, recent mothers or pregnant women, individuals with eating disorders or very low body weight, people who eat less than 3 meals a day or have an eating window under 12 hours, and diabetics on insulin.Check my eligibility
What is being tested?
The study is testing if adding time-restricted eating (TRE), where participants eat all their meals within an 8-hour period each day, can improve the benefits of standard cardiac rehabilitation in patients with heart conditions. The effectiveness and safety of TRE as part of cardiac rehab will be evaluated.See study design
What are the potential side effects?
While not explicitly stated in this summary, potential side effects from time-restricted eating may include hunger pangs outside of the eating window, fatigue during adjustment periods to new meal times, potential headaches or irritability associated with changes in blood sugar levels.
TREat-CR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to the daily ≥16-hour fast for the 16-weeks of the cardiac rehabilitation program.
Cardiorespiratory fitness as measured by peak volume of oxygen consumption (VO2peak)
Fat mass
Secondary outcome measures
Adverse events
Blood pressure
Fasted blood glucose
+8 moreOther outcome measures
Caloric intake
Cardiac rehabilitation adherence
Macronutrient ratios
+3 moreTREat-CR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard cardiac rehabilitation + TREExperimental Treatment2 Interventions
Participants in this group will receive the same standard assessment and individualized recommendations as the comparator group, but will also be counselled to restrict their eating to between 11 am and 7 pm during the program starting the evening of the consultation. They will also be advised to perform their home-based exercise sessions during the fasting period in the morning.
Group II: Standard cardiac rehabilitationActive Control1 Intervention
The 16-week program consists of physician-directed risk factor management, an individualized aerobic and resistance exercise prescription, and virtual education on disease management and lifestyle behaviors (including exercise safety, stress management, and heart-healthy nutrition), and an assessment with a registered dietitian and individualized recommendations for a heart-healthy diet. Additionally, selected patients with identified issues such as depression, anxiety, trouble sleeping, anger and social and emotional issues will receive one-on-one counselling with a psychologist or social worker.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-Restricted Eating
2019
N/A
~160
Find a Location
Who is running the clinical trial?
University Health Network, TorontoOTHER
1,482 Previous Clinical Trials
486,356 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
8,023 Patients Enrolled for Coronary Artery Disease
University of TorontoLead Sponsor
693 Previous Clinical Trials
1,020,026 Total Patients Enrolled
14 Trials studying Coronary Artery Disease
4,744 Patients Enrolled for Coronary Artery Disease
Paul Oh, MDPrincipal InvestigatorUniversity Health Network, Toronto
5 Previous Clinical Trials
379 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
169 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You eat within a time period of less than 12 hours each day, or you consistently eat fewer than 3 meals each day for the past 3 months.You have a history of an eating disorder that you have reported yourself.I am underweight or show signs of severe weight loss.You work at night or have a schedule that changes regularly.My participation helps maintain gender balance in the study.You cannot do a test to check how well your heart and lungs are working, or you have reasons not to do this test.You have type 1 diabetes.I have type 2 diabetes and need insulin injections.I am eligible for outpatient cardiac rehab for coronary artery disease.
Research Study Groups:
This trial has the following groups:- Group 1: Standard cardiac rehabilitation
- Group 2: Standard cardiac rehabilitation + TRE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the purpose of this experiment?
"This 16 week clinical investigation seeks to evaluate cardio-respiratory fitness by measuring peak oxygen consumption (VO2peak). Secondary endpoints include self-reported nutritional adverse events, hemoglobin A1c levels determined via a blood draw, and the Seattle Angina Questionnaire score."
Answered by AI
Are any new volunteers being accepted for this clinical experiment?
"Unfortunately, the information on clinicaltrials.gov reports that this trial has ended recruitment and is no longer seeking participants. The study was first listed on July 11th 2022 but last revised on July 15th 2022. Nevertheless, there are 573 other trials actively recruiting patients right now."
Answered by AI
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