β -hydroxy β-methylbutyrate (HMB) supplementation to improve functional status in people with advanced liver cirrhosis: a multicentre double blind placebo-controlled randomised trial: BOOST
Advanced liver cirrhosis
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) Randomisation is via an online tool Follow-up is 24 weeks post-baseline (12 weeks post-treatment). Previous interventions: Intervention: 3 g of HMB (nutritional supplement) daily for 12 weeks, oral administration of 3 x 500 mg capsules twice daily Matched placebo (maltodextrin) Randomisation is via an online tool Follow-up is 24 weeks post-baseline (12 weeks post-treatment).
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
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