RecruitingNAINTERVENTIONAL

Time Restricted Eating and Cardiac Rehabilitation

This study is investigating a type of eating called time-restricted eating (TRE), sometimes known as intermittent fasting. It involves eating all your meals within a specific time window, usually 8 hours a day, and then fasting for the remaining 16 hours. We're testing if adding this eating pattern to standard heart rehabilitation for people with coronary artery disease is safe and helpful. The main goal is to see if people can stick to the TRE plan easily and without problems. We also want to find out if combining TRE with heart rehabilitation offers extra health benefits, such as improving fitness and reducing body fat, compared to heart rehabilitation alone.

At a glance

Status

Recruiting

Phase

Sponsor

University of Toronto

Enrolment target

Start

11 Jul 2022

Estimated completion

31 Dec 2025

Coronary Artery Disease

What is this study about?

This study is about exploring a specific way of eating called 'time-restricted eating' (TRE) in combination with a program called cardiac rehabilitation. Cardiac rehabilitation is a common and very important program that helps people recover and improve their health after a heart event or diagnosis like coronary artery disease. It typically includes exercise, education, and advice on healthy living.

Time-restricted eating means you eat all your daily food within a certain timeframe, often an 8-hour window, and then you don't eat anything for the remaining 16 hours. For example, you might eat between 10 AM and 6 PM and then fast from 6 PM until 10 AM the next day. This isn't about cutting down on how much you eat, but rather changing when you eat. Some studies have suggested that this way of eating might have benefits for heart health and can work well with exercise.

We want to find out two main things: Firstly, is it easy and safe for people to follow this eating pattern while also doing their cardiac rehabilitation? We'll be looking to see if there are any unexpected problems or if people find it too difficult. Secondly, we're hoping to see if adding time-restricted eating makes cardiac rehabilitation even more effective. For example, could it lead to better fitness, help reduce body fat, or improve other health markers like blood pressure or blood sugar levels, compared to just doing cardiac rehabilitation on its own?

Key takeaways

This study explores a specific eating pattern (time-restricted eating) combined with heart rehabilitation.
The main goals are to check if this eating pattern is safe, easy to follow, and provides extra health benefits.
You would be randomly assigned to either standard rehabilitation or rehabilitation plus the eating pattern.
Participation involves health assessments like fitness tests, body measurements, and blood tests.
Your safety is paramount, and you can withdraw from the study at any time.
The study aims to improve outcomes for people with coronary artery disease.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You should have been referred to or already be taking part in a cardiac rehabilitation program for coronary artery disease or a similar condition affecting blood flow to your legs.

It's important that you are willing to accept being randomly assigned to one of the study groups (either standard care or standard care plus time-restricted eating) and can complete all the necessary health check-ups and assessments. We also need you to understand English well enough to give your consent and communicate with the study team.

However, some things would mean you couldn't join. For example, if you have a history of an eating disorder, are pregnant or breastfeeding, are very underweight, or have certain types of diabetes (Type 1, or Type 2 requiring insulin). If you work night shifts or rotating shifts, or if you already consistently eat very few meals a day, you also may not be suitable. You also need to be able to safely do exercise tests.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been referred for or are you doing cardiac rehabilitation for coronary artery disease or similar condition?
Are you able to communicate in English and understand study information?
Do you *not* have a history of eating disorders or very low body weight?
Are you *not* pregnant, breastfeeding, or working consistent night/rotating shifts?
Are you able to safely perform exercise tests?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will be alongside your regular cardiac rehabilitation program. You will be randomly placed into one of two groups. One group will follow the standard cardiac rehabilitation, and the other will add the time-restricted eating plan to their rehabilitation. The time-restricted eating involves eating all your food within an 8-hour window each day, fasting for 16 hours.

You will have several assessments throughout the study. These will include fitness tests (like a VO2 peak test to measure how well your body uses oxygen), measurements of your body (like weight, body fat, and waist size), and blood tests to check things like sugar levels and cholesterol. You may also be asked to keep a food diary or answer questions about your lifestyle and how you're feeling. The study will last for the usual duration of a cardiac rehabilitation program, with follow-up assessments to see how you're doing. The research team will explain the exact schedule and duration in detail.

Potential risks and benefits

Participating in this study might offer several potential benefits. If time-restricted eating proves effective, you could see improved fitness, reduced body fat, and better control over blood sugar and blood pressure, adding to the benefits of your cardiac rehabilitation. However, there are also potential risks. You might find the time-restricted eating pattern challenging to stick to, or it could potentially cause mild side effects like hunger or fatigue initially. All procedures, especially exercise and blood tests, carry a small, known risk. Your safety is very important, and you will be carefully monitored throughout. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (1)

Toronto Rehabilitation Institute, University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is time-restricted eating?

It's an eating pattern where you eat all your daily food within a limited time window, usually 8 hours, and then fast for the remaining 16 hours each day.

Will I have to eat less food?

The study isn't about reducing how much you eat, but rather changing *when* you eat within the limited time window.

What is cardiac rehabilitation?

It's a supervised program including exercise, education, and support to help people recover and improve their health after a heart problem.

Will I know if I'm doing the time-restricted eating or not?

Yes, you will know which group you are in. The study involves you being randomly assigned to either the standard rehabilitation or rehabilitation plus the eating plan.

What if I can't stick to the eating plan?

The research team will provide guidance, but if you find it too difficult or have concerns, it's important to discuss this with them. You can also withdraw from the study at any point.

How to find out more

Amy Kirkham, PhD

amy.kirkham@utoronto.ca ‭(416) 946-4069‬ Official trial record

Always speak to your GP or specialist before deciding to take part in a study.