Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Muchineripi Kanengoni
+44 (0)1752 01752 432842
m.kanengoni1@nhs.net


Prof Ashwin Dhanda
+44 (0)1752 432 723
ashwin.dhanda@plymouth.ac.uk


Ms Kayle-Anne Sands
+44 (0)1752 437513
boost.penctu@plymouth.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - HMB to improve functional status in people with liver cirrhosis
Back

HMB to improve functional status in people with liver cirrhosis

Recruiting

Open to: All Genders

Age: Mixed

London Nottingham Glasgow Wolverhampton Plymouth Hull Exeter Liverpool

Medical Conditions

Advanced liver cirrhosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Cirrhosis is liver scarring, caused mainly by alcohol or fatty liver in the UK. People with cirrhosis have a poorer quality of life than healthy people. As cirrhosis worsens, they develop more symptoms and require hospital admissions. Cirrhosis causes over 75,000 admissions and costs the NHS ÂŁ17 billion annually. A leaky gut, due to the breakdown of the gut lining, drives liver damage in cirrhosis. Changes in gut bacteria mean there are fewer bacteria that can break down fibre into short-chain fatty acids (SCFAs). SCFAs are important for the proper function of cells lining the gut. Without them the gut becomes leaky, letting parts of bacteria into the bloodstream leading directly to the liver. This triggers liver inflammation and scar formation. There are no treatments for liver scarring or leaky gut. Increasing gut SCFAs may be effective in treating cirrhosis by restoring the gut lining. HMB, a naturally occurring substance that is already available as a dietary supplement to increase muscle strength, also increases SCFA levels in the gut. In small test trials, HMB was safe and had only minor side effects in people with cirrhosis. We will conduct a trial of HMB compared to a dummy treatment (placebo) in 124 patients with cirrhosis from four hospital outpatient clinics in England.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Aug 2025 31 May 2026

Patients will be randomly allocated to HMB or placebo twice daily for 12 weeks and followed up for another 12 weeks. At the start and during the trial we will measure the Liver Frailty Index, a combination of strength and function tests, and measures of liver disease, quality of life and mental wellbeing. The researchers will consider the treatment effective if there is meaningful improvement in the Liver Frailty Index after 12 weeks of HMB compared to placebo.


Patients aged 18 to 85 years with cirrhosis

You can take part if:


Current inclusion criteria as of 09/05/2025:
1. Cirrhosis diagnosed by any of the following:
1.1. Clinical features of cirrhosis as determined by an experienced clinician
1.2. Radiological features on ultrasound or cross-sectional imaging
1.3. Histological evidence of cirrhosis
1.4. Fibrosis assessment by transient elastography with stiffness >15 kPa
2. Advanced cirrhosis defined as Child Pugh score of 7 or more (based on laboratory values and clinical assessment within the previous 6 months)
3. Evidence of portal hypertension within the previous 6 months defined by:
3.1. Presence of ascites
3.2. Presence of oesophageal or gastric varices
3.3. Splenomegaly >13 cm in maximum diameter
3.4. Episode of hepatic encephalopathy
4. Ability to provide informed consent to participate
5. Particip


You may not be able to take part if:


Current exclusion criteria as of 09/05/2025:1. Estimated prognosis limited to less than 6 months2. Advanced hepatocellular carcinoma3. The consumption of HMB, or products containing HMB, within the previous 4 weeks4. Inability to complete the Liver Frailty Index5. Liver transplant recipient6. On the liver transplant waiting list or being considered or under assessment for liver transplant7. Participant in any other interventional trial within previous 4 weeks8. Previous history of poor engagement with clinical services, at the discretion of local PI9. Previous history of hypersensitivity reactions or allergy to exogenous HMB supplements or any of its excipients

Previous exclusion criteria:1. Estimated prognosis limited to less than 6 months2. Advanced hepatocellular carcinoma3. The consumption of HMB, or products containing HMB, within the previous 4 weeks4. Inability to complete the Liver Frailty Index5. Liver transplant recipient6. On the liver transplant waiting list or being considered or under assessment for liver transplant7. Participant in any other interventional trial within previous 4 weeks8. Previous history of poor engagement with clinical services, at the discretion of local PI


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St George's University Hospitals NHS Foundation Trust
    St George's Hospital Blackshaw Road Tooting
    London
    SW17 0QT
  • Nottingham University Hospitals NHS Trust
    Trust Headquarters Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH
  • NHS Greater Glasgow and Clyde
    J B Russell House Gartnavel Royal Hospital 1055 Great Western Road Glasgow
    Glasgow
    G12 0XH
  • The Royal Wolverhampton NHS Trust
    New Cross Hospital Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • University Hospitals Plymouth NHS Trust
    Derriford Hospital Derriford Road Derriford
    Plymouth
    PL6 8DH
  • Hull University Teaching Hospitals NHS Trust
    Hull Royal Infirmary Anlaby Road
    Hull
    HU3 2JZ
  • Royal Devon University Healthcare NHS Foundation Trust
    Royal Devon University NHS Ft Barrack Road
    Exeter
    EX2 5DW
  • Liverpool University Hospitals NHS Foundation Trust
    Aintree University Hospital Lower Ln Fazakerley
    Liverpool
    L9 7AL

If the study shows HMB is effective, the researchers will work with national societies and healthcare professionals to encourage the regular use of HMB in routine patient care without delay as it is cheap and widely available. If participants are allocated to the HMB group they might experience an improvement in their physical wellbeing, but they might not. If they are in the placebo group or do not benefit directly, their participation will help us learn more about HMB as a treatment for liver cirrhosis. In this way, participation may benefit people with advanced cirrhosis in the future.
This trial is categorised as: Type A: No higher than the risk of standard medical care. HMB is a nutritional supplement that is available to the public for purchase without prescription or restriction at health food shops or online vendors. Participants will be monitored for adverse events during trial participation.
There is a risk of bleeding, infection and discomfort from additional blood samples being taken that are not standard of care. Venepuncture is a common procedure that will be carried out by appropriately trained staff at site only. Where routine bloods have been carried out in the 4 weeks before a visit to calculate Child-Pugh and MELD scores, these results may be used for trial data to minimise the amount of blood taken at each visit, where possible. Participants will be informed of risks associated with venepuncture in the PIS (e.g., discomfort, bruising, redness, fainting, vein puncture and swelling at the site where the needle goes in).

Dr Muchineripi Kanengoni
+44 (0)1752 01752 432842
m.kanengoni1@nhs.net


Ms Kayle-Anne Sands
+44 (0)1752 437513
boost.penctu@plymouth.ac.uk


Prof Ashwin Dhanda
+44 (0)1752 432 723
ashwin.dhanda@plymouth.ac.uk



The study is sponsored by University Hospitals Plymouth NHS Trust and funded by Research for Patient Benefit Programme.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN99030459

Or CPMS 64115

Last updated 01 September 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top