RecruitingNAINTERVENTIONAL

Intermittent Carbohydrate Restriction in Cardiometabolic Health

This study is exploring different ways of reducing carbohydrates in the diet to improve health in adults who are overweight. We want to understand if cutting down carbs on two days a week, or only after 4 pm each day, can help with weight loss and other health markers. The research will also look at how these changes affect the body and if any positive effects can last over time with the help of a digital health app. The aim is to find new and effective lifestyle strategies to help prevent conditions like heart disease and type 2 diabetes.

At a glance

Status

Recruiting

Phase

Sponsor

University of Bath

Enrolment target

Start

05 Sep 2023

Estimated completion

01 Oct 2036

Obesity and Overweight

What is this study about?

This research is looking into how different ways of reducing carbohydrates in your diet might help improve your health, especially if you're overweight or living with obesity. Conditions like heart disease and type 2 diabetes are very common and can significantly impact people's lives, so finding new ways to manage them through lifestyle changes is really important.

The study will look at two specific approaches: one where people reduce their carbohydrate intake for two days a week, and another where people cut down on carbs only later in the day (after 4 pm). We want to understand how these different patterns affect your weight and various health indicators. We'll also explore the reasons why these changes might happen by looking at your body's processes. After the main diet part, there's also a section using a mobile app to see if any benefits can be maintained and supported over time.

Ultimately, this research aims to provide a clearer picture of whether these dietary strategies are effective and how they work. This information can then help guide future public health advice on leading a healthier lifestyle and reducing the risk of developing metabolic conditions.

Key takeaways

Exploring two diet approaches: carbs restricted two days a week, or carbs restricted after 4 pm daily.
Aims to understand impacts on weight and overall health in overweight adults.
Involves a 10-week study period with lab visits and at-home monitoring.
Includes a mobile app phase to support lasting healthy habits.
Focuses on practical lifestyle changes to reduce health risks.
Volunteers should be between 18 and 65, with specific waist size/BMI criteria.

Who may be eligible?

To be able to take part in this study, you would generally need to be an adult between 18 and 65 years old. You should have a waist size of at least 37 inches (94 cm) if you're a man, or at least 31.5 inches (80 cm) if you're a woman, or your Body Mass Index (BMI) should be above 25. Your body fat levels will also be checked to make sure you fit the study criteria.

There are also some important reasons why you might not be able to join. For example, if you weigh 120kg (around 19 stone) or more, or if you're already trying to lose weight through other methods, you might not be suitable. This also applies if you have any major ongoing health conditions like type 2 diabetes or heart disease, or if you're taking medications that could affect the study results. People who are pregnant, breastfeeding, or planning to get pregnant soon won't be able to participate.

We also need to make sure participants can understand and follow all instructions, and don't have certain dietary restrictions (like severe gluten intolerance) or irregular sleep patterns, such as working night shifts.

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 18 and 65 years old?
Do you have a waist size of 37 inches (men) or 31.5 inches (women) or more?
Have you kept a stable weight for the last three months (no major changes)?
Do you currently have major health conditions like diabetes, heart disease, or cancer?
Are you taking medications that affect blood sugar or cholesterol levels?
Are you pregnant, breastfeeding, or planning to get pregnant soon?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it will last for a total of ten weeks. It starts with two weeks where your usual lifestyle is monitored. Then, for four weeks, you'll be asked to follow one of three groups: either reducing carbohydrates on two consecutive days each week, cutting down carbs only after 4 pm daily, or continuing with your usual diet. After this, there will be a four-week phase where you'll use a mobile app that offers personalised healthy living advice.

Throughout the study, you'll visit a laboratory four times during each phase (so twelve visits in total) for various health checks. These checks might include body measurements, scans to look at your body make-up, blood pressure checks, and taking blood and breath samples after meals. You'll also wear devices at home to track your diet, physical activity, and blood sugar levels. You should continue with any regular medications as advised by your doctor, but the researchers will check if any of these might affect the study outcomes.

Potential risks and benefits

Participating in research always has a balance of potential benefits and risks. You might gain a better understanding of your own health and how diet affects it, and potentially improve some health markers. However, there's always a possibility that the dietary changes might not suit everyone, or that some of the tests, like blood samples, may cause slight discomfort. The researchers will explain all procedures carefully. Remember, you can choose to withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (1)

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

University of Bath
Verified postcode
Bath, United Kingdom· Recruiting

Common questions

What kind of foods are considered 'carbohydrates' in this study?

Carbohydrates are found in foods like bread, pasta, rice, potatoes, sugary snacks, and some fruits and vegetables. The study will provide clear guidance on what to limit.

Will I have to eat special meals during the study?

The study does not specifically mention special meals. You will be asked to restrict carbohydrates based on a schedule, but within your usual diet.

What does 'digital behaviour-change intervention' mean?

This refers to using a mobile phone app that will give you personalised advice and educational information to help you maintain healthy habits after the main diet phase.

How much blood will be taken during the study?

Blood samples will be taken during some of the laboratory visits. The researchers will explain the exact amount, but it will be safely within medical guidelines.

Do I need to change my exercise routine for this study?

The study aims to understand the impact of diet changes. You will be asked to maintain your usual physical activity levels during the study unless advised otherwise by the research team.

How to find out more

Guoda Karoblyte

gk678@bath.ac.uk +44 (0) 1225 386478 Official trial record

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