RecruitingNAINTERVENTIONAL

The Effect of Time-Restricted Eating in Cardiometabolic Health

This research is investigating an eating pattern called 'time-restricted eating' (TRE). This means eating all your meals and snacks within a specific 9-hour window each day, and not eating for the rest of the day. The study aims to understand how this 9-hour eating window might affect the heart and overall metabolic health of people who are overweight or have prediabetes. We want to see if this eating approach, even without trying to lose weight, can improve things like how your body uses sugar (insulin sensitivity), your daily metabolism, and how fat and muscle cells work. The goal is to learn more about the potential health benefits of TRE for these conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

100

Start

01 Nov 2023

Estimated completion

31 Aug 2028

Obesity PreDiabetes

What is this study about?

This study is looking into a way of eating called 'time-restricted eating', or TRE. Imagine you pick a 9-hour window each day – for example, from 9 AM to 6 PM – and you eat all your daily meals and snacks only within that time. For the remaining hours of the day and overnight, you wouldn't eat anything. This study wants to find out if this way of eating can improve important health measures for people who are overweight and have prediabetes.

We know from studies in animals that TRE might help the body work better metabolically, even if the animals don't eat fewer calories overall. It seems to help with how the body uses energy and with its natural daily rhythms. However, we don't fully understand yet how this works for people, especially when it comes to keeping the heart and blood vessels healthy.

That's why our researchers are carrying out this study. We want to see if following a 9-hour eating window for 12 weeks can make a positive difference without people trying to change their weight. Specifically, we'll be looking at things like how sensitive your body is to insulin (which helps your body use sugar), your body's daily metabolic patterns, and the health of your fat and muscle cells. This research will help us better understand the health effects of time-restricted eating for individuals with obesity and prediabetes.

Key takeaways

Investigating a 9-hour daily eating window for health benefits.
Aimed at people who are overweight and have prediabetes.
Focuses on improving heart and metabolic health, not weight loss.
Study lasts for 12 weeks with regular health check-ups.
Could help understand new ways to manage prediabetes and improve health.

Who may be eligible?

To join this study, you generally need to be between 25 and 75 years old. You should be someone who is overweight (your Body Mass Index, or BMI, is between 27 and 45) and has prediabetes. This means your blood sugar levels are higher than normal but not yet high enough to be diagnosed with type 2 diabetes. You also need to be currently eating for 13 hours or more each day.

There are some reasons why you wouldn't be able to join. For example, if you work shifts, are a vegan, or regularly fast for more than 12 hours a day, you might not be suitable. We also can't include people who already have type 1 or type 2 diabetes, a diagnosed sleep or eating disorder, or a history of cancer in the last five years. If you've had certain types of stomach surgery, are pregnant or breastfeeding, smoke, or use illegal drugs, you also wouldn't qualify. We need to make sure the study is safe and accurate for everyone involved.

Additionally, if you take certain medications that could affect the study results or pose a risk, or if you have any medical conditions that would make it hard to complete the study procedures (like known allergies to study medicines), you wouldn't be able to take part. It's important that you can understand and agree to all the study instructions.

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 between 25 and 75 years old?
Is your Body Mass Index (BMI) between 27 and 45?
Do you have prediabetes (not full diabetes)?
Do you usually eat for 13 hours or more each day?
Are you a non-smoker and do not use illegal drugs?
Have you not been diagnosed with type 1 or 2 diabetes, or a sleep/eating disorder?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to either the group that follows the 9-hour time-restricted eating pattern or a group that eats over a more extended period. Both groups will be asked to maintain a healthy diet. The study will last for 12 weeks.

During this time, you will have several clinic visits to assess your health. These visits will involve various tests to measure your body's response to the eating pattern. These could include checking your blood sugar levels, how your body uses insulin, and looking at the health of your fat and muscle tissues. The researchers will explain all procedures in detail before you start.

There won't be any specific medications given as part of the main study; it focuses on the eating pattern. You'll have regular check-ups and monitoring throughout the 12 weeks to see how you're progressing. The total duration of your active involvement in the study will be these 12 weeks.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing valuable information to help others with obesity and prediabetes understand new ways to improve their health. You will also receive regular health monitoring and information about your own health markers during the study. On the other hand, there are some potential risks. Adjusting to a new eating window might be challenging for some people, and it could lead to temporary discomfort, changes in energy levels, or hunger, especially at the start. As with any medical study, there's a small chance of unforeseen side effects from the assessments, though all procedures are designed to be safe. You have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cambridge Clinical Research Center
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is 'time-restricted eating'?

It means eating all your daily food within a set number of hours (this study uses 9 hours) and not eating during the remaining hours of the day and night.

Do I have to lose weight on this study?

No, the main goal of this study is not weight loss. It's to see how the eating pattern affects other health markers, like blood sugar and metabolism, without focusing on changing body weight.

How long will the study last if I join?

If you take part, your active involvement in the time-restricted eating or control eating pattern will last for 12 weeks.

Will I be told what to eat?

Both groups in the study will be encouraged to follow a healthy diet, but the main intervention focuses on when you eat, not strictly what you eat, beyond general healthy eating advice.

Is this study suitable for people with diabetes?

No, this study is for people with prediabetes, not those who have already been diagnosed with type 1 or type 2 diabetes.

How to find out more

Maria Chondronikola

mc2425@medschl.cam.ac.uk 01223746784 Official trial record

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