A dietary supplement used to build muscle – or prevent muscle loss as a result of ageing or illness – is to be trialled as a potential treatment for chronic liver disease.
Β-hydroxy β-methylbutyrate, otherwise known as HMB, is used predominantly to build muscle bulk and function but previous studies have demonstrated it can have clinical applications.
In a new study, scientists and clinicians will test its potential to benefit some of the 60,000 people in the UK who have been diagnosed with cirrhosis, a condition that results from scarring to the liver.
In the UK, cirrhosis is most commonly caused by harmful alcohol use or fatty liver disease. In severe cases, those affected either face the prospect of a liver transplant or simply being treated for some of the symptoms of the disease.
As cirrhosis worsens, patients’ symptoms can worsen and it is estimated that the condition causes over 75,000 admissions and costs the NHS £17 billion annually.
The BOOST study will explore whether taking HMB can offer a safe and effective way of improving patients’ physical function and quality of life.
The study is being carried out by experts in liver disease, dietetics and immunology from the University of Plymouth, University of Southampton and Imperial College, London. The trial will be managed by Peninsula Clinical Trials Unit (PenCTU) and is supported by PenARC.
Running until 2027, it is being supported with funding of £500,000 from the Research for Patient Benefit (RfPB) programme run by the National Institute for Health and Care Research (NIHR).
In Plymouth, the project will involve members of PenARC, the University’s Hepatology Research Group, and PenCTU, as well as clinicians and patients at University Hospitals Plymouth NHS Trust, which is also a sponsor of the project.
Dr Ashwin Dhanda, Associate Professor in Hepatology at the University of Plymouth and a Consultant in Hepatology at University Hospitals Plymouth NHS Trust, is the project’s Chief Investigator. He said:
“Cirrhosis is a condition that can have a significant impact on a person’s physical and mental wellbeing. But while there are treatments in development, at the moment there is nothing we can prescribe that directly addresses the condition. HMB has been identified as having the potential to fill that gap, with no suggestions at this time that there will be adverse side effects. This trial will hopefully enable us to test that fully, and establish whether HMB can indeed deliver real benefits for people with cirrhosis and those around them.”
Those leading the project also held meetings with patients diagnosed with liver cirrhosis to discuss how best to carry out the trials and to understand any particular benefits they hoped to gain from taking part.
Early this year, the study will be looking to recruit 124 patients with cirrhosis from eight hospital outpatient clinics in England, including a number in deprived areas where there are higher instances of cirrhosis.
Patients will be randomly allocated to take HMB or a placebo twice a day for 12 weeks, and then have follow-up checks for another 12 weeks.
At the start and during the trial, the researchers will measure the Liver Frailty Index, a combination of strength and function tests, and carry out other tests to examine any changes in patients’ liver disease, quality of life and mental wellbeing.
Lesley Manning has lived experience of advanced cirrhosis and has previously received a liver transplant. She is a member of the project team and will work with other people with lived experience to make sure the patient perspective is included in all aspects of running the trial. She said:
“Living with advanced cirrhosis is very debilitating. It makes you feel like you have no energy or strength, and there are no treatments out there to help manage your symptoms. I believe you need to look after yourself and the BOOST trial is testing something simple and safe that may improve the quality of life of people with advanced cirrhosis.”