RecruitingNAINTERVENTIONAL

The Causal Role of Ketone Bodies in Obesity-associated Disease Prevention - Combining Genetic Epidemiology With a Randomised Trial to Infer Causality

Being overweight can increase your risk of serious health problems like heart disease, diabetes, and certain cancers. While low-carb diets, which increase a chemical called ketones in your body, have been shown to help with weight, they can also have unhealthy aspects. This study aims to find out if ketones themselves are truly helpful for preventing these diseases, or if it's just the diet. Researchers will combine a short, controlled study with information from genetics to understand the long-term effects of ketones. They're also investigating if taking ketone supplements could give you the benefits of ketones without needing to follow a strict, potentially unhealthy diet.

At a glance

Status

Recruiting

Phase

Sponsor

University of Bath

Enrolment target

Start

06 May 2025

Estimated completion

01 Jan 2030

Nutrition Obesity and Overweight

What is this study about?

Being overweight or moderately obese can put you at higher risk for various health issues, including heart disease, type 2 diabetes, kidney problems, and certain cancers. We urgently need new ways to help prevent these diseases, especially for people who might not need strong medications yet.

Some popular diets, known as ketogenic or 'keto' diets, involve eating very few carbohydrates. These diets can help with weight control and increase the amount of natural chemicals called ketones in your body. Ketones are thought to have good effects on your heart and metabolism (how your body uses energy). However, keto diets often involve a lot of unhealthy fats and red meat, and not enough fibre, so their long-term health effects aren't fully understood. Interestingly, you can also increase ketones in your body by taking special supplements, which might offer the benefits of ketones without the potential risks of a strict diet.

This study is using a clever combination of research methods to get a clearer picture. It brings together a small, carefully controlled short-term study where people will either follow a specific diet or take a supplement, with a technique called Mendelian Randomisation. This genetic approach helps scientists understand how short-term changes in your body, like those caused by ketones, might affect your health over many years. By combining these methods, the researchers hope to overcome limitations of previous studies and find out for sure whether ketones can help prevent diseases linked to being overweight.

Key takeaways

This study investigates if ketones can prevent diseases linked to being overweight.
It compares strict low-carb diets with ketone supplements.
Researchers are using genetic information alongside a short-term study.
The goal is to understand the long-term health effects of ketones.
Participation involves specific health checks and potentially following a diet or taking supplements.

Who may be eligible?

To be considered for this study, you need to be an adult between the ages of 18 and 65. Your Body Mass Index (BMI) should be between 25 and 45. There are also specific waist measurements for men and women that determine eligibility.

You cannot take part if you are currently on medication to lower your blood sugar or cholesterol levels. If you have been diagnosed with heart disease, kidney problems, liver disease, or type 2 diabetes, you won't be able to join. There are also specific health conditions that make a ketogenic diet unsafe, so if you have any of these, you won't be able to participate. Finally, you need to be able to understand English to take part.

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?
Is your BMI between 25 and 45?
Are you able to understand English?
Are you NOT currently taking medication for blood sugar or cholesterol?
Do you NOT have a diagnosis of heart, kidney, or liver disease, or type 2 diabetes?
Have you NOT been told a ketogenic diet is unsafe for you due to a specific health condition?

Answer every question to see your result.

What does participation involve?

Details about what taking part involves are not fully described in the provided summary. However, it mentions a 'tightly controlled, short-term RCT,' which suggests that if you participate, you would likely be asked to follow a specific diet or take a ketone supplement for a defined period. This would probably involve regular visits to the study site for health assessments, such as blood tests, to track the levels of ketones and other markers in your body, both when you haven't eaten (fasted) and after meals. The overall duration of your active participation is expected to be short. More information about the exact schedule and time commitment would be provided by the research team.

Potential risks and benefits

Potential benefits of participating could include contributing to important research that might lead to new ways to prevent obesity-related diseases. You might also gain insights into your own health during the study. Potential risks, particularly if following a ketogenic diet, could include side effects like 'keto flu' (headache, fatigue, nausea), and uncertainties about the long-term effects of such a diet. If taking ketone supplements, potential side effects are usually mild but can include digestive upset. All specific risks would be fully explained by the study team. Remember, you have the 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.

University of Bath
Verified postcode
Bath, United Kingdom· Recruiting

Common questions

What are ketones?

Ketones are natural chemicals your body makes when it breaks down fat for energy, especially if you eat very few carbohydrates.

What is a 'ketogenic diet'?

It's a very low-carbohydrate diet that encourages your body to burn fat for fuel, producing ketones.

What are 'ketone supplements'?

These are products you can take that directly increase the levels of ketones in your body, aiming to get the effects without strict dieting.

Why are researchers looking at ketones for obesity-related diseases?

Scientists believe ketones might have protective effects against conditions like heart disease and diabetes, and this study wants to confirm if that's true.

What does a 'tightly controlled, short-term study' mean?

It means the study will be very precise, likely with specific meal plans or supplement doses, and will run for a shorter period, focusing on immediate changes in the body.

How to find out more

Javier Gonzalez

j.t.gonzalez@bath.ac.uk +441225385518 Official trial record

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