RecruitingInterventional

Using a ketogenic diet to help prevent muscle wasting in critically ill patients

This study explores if a special diet, known as a ketogenic diet, can prevent muscle wasting in seriously ill adults in intensive care units (ICU). Many patients lose significant muscle strength during severe illness, making it hard to get back to normal life afterwards. Researchers hope this medical food can help these patients recover faster and regain their independence. They will compare this special diet to standard feeding in 282 patients, measuring their ability to stand up from a sitting position as a key indicator of strength. The study aims to find a safe and effective way to reduce long-term problems caused by muscle weakness after critical illness. It's a UK-based study running from April 2026 to December 2028, funded by the National Institute for Health and Care Research (NIHR).

At a glance

Status

Recruiting

Sponsor

Barts Health NHS Trust

Enrolment target

282

Start

01 Jun 2026

Estimated completion

01 Jun 2028

Acute muscle wasting in critically ill adults

What is this study about?

When people become very sick and need to stay in intensive care, their bodies often start to lose a lot of muscle very quickly. This muscle loss can be quite severe, sometimes as much as a kilogram (or over two pounds) of muscle every day. This makes it incredibly difficult for them to get back on their feet afterwards. Things we usually take for granted, like washing, dressing, or even just walking, become a huge struggle or impossible without help. Unfortunately, many patients struggle with this for a long time; even a year later, many can't return to work or need extra help with daily activities.

This study is looking at a new way to try and prevent this serious muscle wasting. We're testing a special medical food, which is a type of ketogenic diet, given through a feeding tube. This diet has been designed to be safe and could potentially help protect muscles during critical illness. The main goal is to see if giving this special diet can help patients recover their strength more effectively, making them more independent when they leave the hospital and get back to their lives.

We will be comparing this special feeding with the usual feeding patients receive in intensive care. We want to see if those on the ketogenic diet can recover enough strength to do everyday activities better, such as standing up from a chair by themselves. This simple action is a really important step towards regaining independence and reducing the need for help with daily tasks, and it also helps prevent falls.

Key takeaways

A study testing a special 'ketogenic' medical feed for seriously ill ICU patients.
Aims to prevent severe muscle loss, which is common in critical illness.
Could help patients recover strength and independence more quickly.
Compares the special feed to standard feeding through a tube.
Minor side effects like stomach upset are possible, but serious risks are not expected.
Participation involves close monitoring, extra blood samples, and muscle ultrasounds.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) currently in an intensive care unit (ICU).

Generally, you could be considered if you are in the ICU because of severe breathing problems and are expected to need breathing support for more than two days, and have signs of inflammation. Alternatively, you might be considered if you have issues with several organs and are expected to need feeding through a tube for more than two days.

However, there are reasons you wouldn't be able to join. For example, if you already have conditions that would stop you from being able to sit down and stand up on your own (like severe frailty, certain brain conditions, or amputations). Also, if doctors think you're unlikely to survive for at least 30 days, or if you can't be fed through a tube, or if you have certain rare metabolic conditions, you wouldn't be able 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 18 years old or older?
Are you currently in an adult intensive care unit (ICU)?
Do you need a feeding tube for more than 48 hours?
Are you able to do a 'sit-to-stand' test (or expected to be able to in the near future)?
Do you have severe breathing problems or issues with multiple organs?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would be randomly put into one of two groups: one group would receive the special ketogenic medical food through a feeding tube, and the other group would receive standard feeding, also through a tube. This is done by chance, like flipping a coin, so it's fair. The special medical food is provided by a company that already makes medical feeds. We would closely monitor your health while you are in the intensive care unit.

As part of the study, we would perform an ultrasound scan of your muscles, which is a safe procedure. We would also take a small amount of extra blood during routine blood tests that are already being done for your care. A key measurement will be seeing how many times you can stand up from sitting in 30 seconds, if you are able to, as this helps us understand your muscle strength. The main extra thing involved for you would be answering more questions from the study team. The study aims to run until December 2028, but your individual participation would only be while you are in intensive care and for follow-up assessments.

Potential risks and benefits

We cannot guarantee that this study will personally benefit you directly, but we hope that the special medical food we are testing might help prevent muscle loss, which would improve your recovery. If successful, this research could also help many other patients in intensive care in the future. We don't expect any serious side effects, as a ketogenic diet has been safely used in previous studies with critically ill patients and in other groups of people, like those with heart conditions. You might experience some minor stomach upsets, such as diarrhoea. We will closely watch your health to make sure the feeding is safe. Taking a small extra blood sample during routine tests and having a muscle ultrasound are considered very low risk. You are always free to leave the study at any time, for any reason, without it affecting your usual care.

Locations (9)

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

Barts Health NHS Trust
City only
London, England
Guys and St Thomas' NHS Foundation Trust
City only
London, England
St George's Healthcare Nhst
City only
London, England
University Hospitals of North Midlands NHS Trust
City only
Stoke-on-trent, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Barking, Havering and Redbridge University Hospitals NHS Trust
Unverified
Romford, England
Cambridge University Hospitals NHS Foundation Trust
Unverified
Cambridge, England
Cardiff & Vale University Lhb
Unverified
Cardiff, Wales
Kings College Hospital
Unverified
London, England

Common questions

What is a ketogenic diet?

It's a special diet that's very low in carbohydrates, moderate in protein, and high in fats. For this study, it's given as a medical food through a feeding tube.

Why is muscle wasting a problem?

Losing a lot of muscle makes it hard to regain strength and independence after serious illness, affecting daily activities like walking and dressing.

Will I know if I'm getting the special diet or the usual feeding?

No, you wouldn't know which type of feeding you're receiving. This helps make the study results fair and unbiased.

How long will I be involved in the study?

Your involvement would be for as long as you are critically ill in the intensive care unit and potentially for follow-up assessments after that.

Who is paying for this research?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Zudin Puthucheary

z.puthucheary@qmul.ac.uk +44 (0)20 3594 0348 Official trial record

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