Advanced liver cirrhosis Digestive System
Conditions
Interventions
Current interventions as of 09/05/2025:
Intervention: 3 g of HMB (nutritional supplement) daily for 12 weeks, oral administration of to 2 x 750 mg capsules twice daily
Matched placebo (maltodextrin)
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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. Participant is =18 years and =85 years of age Previous inclusion criteria: 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 or, where the participant has hepatic encephalopathy, agreement is provided by a personal or professional representative 5. Participant is =18 years and =85 years of age
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/05/2025: 1. Estimated prognosis limited to less than 6 months 2. Advanced hepatocellular carcinoma 3. The consumption of HMB, or products containing HMB, within the previous 4 weeks 4. Inability to complete the Liver Frailty Index 5. Liver transplant recipient 6. On the liver transplant waiting list or being considered or under assessment for liver transplant 7. Participant in any other interventional trial within previous 4 weeks 8. Previous history of poor engagement with clinical services, at the discretion of local PI 9. 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 months 2. Advanced hepatocellular carcinoma 3. The consumption of HMB, or products containing HMB, within the previous 4 weeks 4. Inability to complete the Liver Frailty Index 5. Liver transplant recipient 6. On the liver transplant waiting list or being considered or under assessment for liver transplant 7. Participant in any other interventional trial within previous 4 weeks 8. Previous history of poor engagement with clinical services, at the discretion of local PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of HMB to improve physical function measured by change in Liver Frailty Index at 12 weeks post-baseline* *Note, LFI is measured at baseline, week 12 and week 24 but the primary outcome is baseline vs week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured using the SF-36 questionnaire at Baseline, Weeks 12 and 24 2. Mental wellbeing measured using the WEMWBS at Baseline, Weeks 12 and 24 3. Liver disease severity measured using the Child-Pugh score at Baseline, Weeks 12 and 24 4. Liver disease severity measured using the MELD score at Baseline, Weeks 12 and 24 5. Cognitive function measured using the animal naming test at Baseline, Weeks 12 and 24 6. Serum SCFA concentrations at Baseline, Weeks 12 and 24 7. LPS, LBP and D-lactate concentrations measured using blood test at Baseline, Weeks 12 and 24 8. Muscle mass measured by calf circumference, corrected for BMI and oedema, at Baseline, Weeks 12 and 24 9. Number, duration and diagnosis of any hospital admissions (self-reported) at Weeks 4, 12 and 24 10. Infections (self-reported and by primary/secondary care records) at Weeks 4, 12 and 24 11. Attendance to and completion of the final study visit (Week 24) 12. Self-report of medication adherence at Weeks 4 and 12 13. Medication adherence measured by pill count measured at Week 12 14. Dietary intake measured using a 24-hour food recall (total macronutrient intake/24 hours - protein, carbohydrate, fat, and fibre) at Baseline, Weeks 12 and 24 15. Contamination assessed by checking HMB supplement use at Baseline, Weeks 4, 12 and 24 16. Safety of intervention measured by adverse reactions and serious adverse events measured at Weeks 4, 12 and 24 | — |
Countries
England, United Kingdom
Contacts
Public ContactKayle-Anne Sands
Outcome results
None listed