RecruitingPhase IVInterventional

HMB to improve functional status in people with liver cirrhosis

This research is investigating whether a common supplement, HMB, can improve the daily lives of people with advanced liver scarring, also known as cirrhosis. In the UK, cirrhosis is often caused by alcohol or fatty liver disease. We know cirrhosis can make people feel unwell and lead to hospital stays. HMB is a natural substance, already sold as a supplement for muscle strength, and early tests suggest it’s safe for people with cirrhosis. This study will involve 124 patients, comparing HMB to a dummy treatment over 12 weeks, followed by another 12 weeks of observation. We'll measure physical function, liver health, mood, and quality of life to see if HMB truly helps people feel better.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University Hospitals Plymouth NHS Trust

Enrolment target

124

Start

14 Aug 2025

Estimated completion

31 Jul 2026

Advanced liver cirrhosis

What is this study about?

If you have liver scarring, also known as cirrhosis, you might know it can really affect your quality of life, often leading to unpleasant symptoms and hospital visits. In the UK, common causes of cirrhosis include drinking too much alcohol or having fatty liver disease. Unfortunately, there aren't many treatments for the scarring itself or for a related issue called 'leaky gut' that can make liver problems worse.

Our current understanding suggests that problems in your gut, specifically with the healthy bacteria that digest fibre, can contribute to liver damage. When these good bacteria are lacking, your gut lining can become 'leaky,' allowing harmful substances to enter your bloodstream and reach your liver, leading to more inflammation and scarring. This study is exploring a natural substance called HMB (Calcium beta-hydroxy-beta-methylbutyrate) as a potential solution. HMB is naturally found in our bodies and is already available as a food supplement, often used to help build muscle strength. Interestingly, HMB also seems to help increase healthy gut bacteria, which could, in turn, help to repair the gut lining and protect the liver.

Early, small-scale tests have shown that HMB is generally safe and has only minor side effects for people with cirrhosis. Because it's already widely available and inexpensive, if this study shows HMB is effective, it could quickly become a regular part of care for people with cirrhosis. This trial will compare HMB to a dummy treatment (a placebo) in 124 patients with cirrhosis over 12 weeks, with observations continuing for another 12 weeks. We'll be carefully checking if HMB can significantly improve people's physical well-being and overall quality of life.

Key takeaways

The study investigates HMB for advanced liver scarring (cirrhosis).
It aims to improve physical strength and quality of life for patients.
HMB is a safe, natural, and widely available supplement.
Participation involves taking HMB or a placebo for 12 weeks and monitoring for another 12 weeks.
Your involvement could help future patients with cirrhosis.
The study assesses functional status, liver health, and well-being.

Who may be eligible?

This study is looking for people aged between 18 and 85 years old who have advanced liver scarring, known as cirrhosis. Your doctor would have diagnosed your cirrhosis using various methods, like blood tests, scans, or a liver biopsy.

To join, your cirrhosis needs to be considered 'advanced.' This often means your liver isn't working as well as it should, and you might have signs like fluid build-up (ascites), swollen veins in your food pipe (varices), or issues with confusion (hepatic encephalopathy). You also need to be able to fully understand the study and agree to take part.

There are some reasons why you might not be able to join. For example, if your doctors think you have less than 6 months to live, or if you have a specific type of liver cancer called advanced hepatocellular carcinoma. Also, if you’re already taking HMB supplements, or have taken them recently, you wouldn't be able to participate.

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 85 years old?
Have you been diagnosed with advanced liver cirrhosis?
Do you have signs of portal hypertension (e.g., fluid build-up, varices, or periods of confusion)?
Are you able to provide consent (agree) to take part?
Are you able to commit to the 24-week study period?
Have you *not* taken HMB supplements recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the HMB supplement or a dummy treatment (placebo). Neither you nor your study doctor will know which one you're getting – this is important for fair results. You'll take the assigned treatment twice a day for 12 weeks.

During this time, and for another 12 weeks after you stop taking the treatment, you'll have regular hospital visits. At these visits, we'll check your physical strength and how well you can do daily tasks. We'll also monitor your liver health, how you're feeling emotionally, and your general quality of life. This involves some tests, including blood samples. The total study period for each participant is 24 weeks.

Potential risks and benefits

If HMB turns out to be effective, patients in the HMB group might experience an improvement in their physical health and overall well-being. Even if you're in the placebo group or don't feel a direct benefit, your contribution is incredibly valuable. You'll be helping us learn more about HMB, which could lead to better treatments for people with advanced cirrhosis in the future. HMB is a nutritional supplement freely available, and this study is considered to have no higher risk than standard medical care. However, there's a small risk of discomfort, bruising, or a mild infection from the extra blood samples taken during the study, as these are common procedures carried out by trained staff.

Locations (10)

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

University Hospitals Plymouth NHS Trust
City only
Plymouth, England
Hull University Teaching Hospitals NHS Trust
City only
Hull, England
Liverpool University Hospitals NHS Foundation Trust
City only
Liverpool, England
Nottingham University Hospitals NHS Trust
City only
Nottingham, England
Royal Devon University Healthcare NHS Foundation Trust
City only
Exeter, England
St George's University Hospitals NHS Foundation Trust
Unverified
London, England
NHS Greater Glasgow and Clyde
Unverified
Glasgow, Scotland
The Royal Wolverhampton NHS Trust
Unverified
Wolverhampton, England
Gateshead Health NHS Foundation Trust
Unverified
Gateshead, England
Northern Lincolnshire and Goole NHS Foundation Trust
Unverified
Grimsby, England

Common questions

What is cirrhosis?

Cirrhosis is severe scarring of the liver, which can make it harder for the liver to work properly.

What is HMB?

HMB is a natural substance, also sold as a dietary supplement, often used to help build muscle strength. We're looking at its effects on liver health.

Will I get HMB or a dummy pill?

To ensure fair results, you'll be randomly given either HMB or a dummy pill (placebo). Neither you nor your doctor will know which one.

How long will I be in the study?

You'll take the treatment for 12 weeks and then be followed up for another 12 weeks, making a total of 24 weeks.

Who is funding this research?

This study is funded by the 'Research for Patient Benefit Programme' in the UK.

How to find out more

Kayle-Anne Sands

boost.penctu@plymouth.ac.uk +44 (0)1752 437513 Official trial record

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