None listed
Conditions
Brief summary
Advanced liver disease, or cirrhosis, is associated with increased morbidity and mortality and patients suffer frequent complications. Sarcopenia, defined as the the loss of muscle mass as well as muscle function, is among the commonest complications, with an estimated prevalence of up to 70%. Sarcopenia is independently associated with reduced survival, increased infection risk and higher rates of hospitalisation in this cohort. Despite this, little is known about how to increase muscle mass in this population. Branched chain amino acids (BCAAs) include three essential amino acids which are used as building blocks for protein and energy in muscle. In addition to being the primary energy source for skeletal muscle, they are also used to help clear toxins that build up in liver disease. Patients with cirrhosis have reduced levels of BCAAs, which is thought to be a major contributing factor that contributes to low muscle mass in these patients. Treating patients with oral BCAA supplements, in the form of a soluble powder, may improve quality of life and overall nutrition in patients with cirrhosis. However, the impact on muscle mass is unknown. Our study aims to investigate the effect of oral BCAA powdered supplements on sarcopenia in patients with cirrhosis. Our randomised trial will compare BCAAs to a control protein supplement to assess whether replacing dietary protein deficit as a whole or BCAAs specifically can influence outcomes. Our primary outcome will be an increase in muscle mass and strength in treated subjects. If we can improve sarcopenia, we anticipate we may also improve other outcomes. Therefore, our secondary outcomes of this study will be improved muscle function, hepatic encephalopathy, insulin resistance, rates of hospitalisation, health care costs, quality of life and overall mortality. Given the higher rates of infections seen in patients with sarcopenia, the second focus of our study will be on immune function through monitoring blood samples and infectious complications.
Interventions
Patients with cirrhosis, muscle weakness as defined by handgrip dynamometer and evidence of low serum albumin or ascites will be invited to participate in the study. 150 patients will be recruited and randomised to the intervention arm and a control arm. The intervention arm will be blinded to receive powdered BCAA supplements. These contain leucine, isoleucine and valine in a 2:1:1 ratio respectively. Patients in the intervention arm will be given powdered BCAA supplements and will be asked to
Patients with cirrhosis, muscle weakness as defined by handgrip dynamometer and evidence of low serum albumin or ascites will be invited to participate in the study. 150 patients will be recruited and randomised to the intervention arm and a control arm. The intervention arm will be blinded to receive powdered BCAA supplements. These contain leucine, isoleucine and valine in a 2:1:1 ratio respectively. Patients in the intervention arm will be given powdered BCAA supplements and will be asked to take 30g orally per day mixed with water, milk or juice. The duration of intervention will be 12 months. Compliance will be monitored through return and weighing of supplement packages at each clinical review.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adult patients who meet the following criteria will be invited to participate 1. Cirrhosis with a radiological, clinical or histological diagnosis 2. A low serum albumin or the presence of ascites 3. Muscle weakness as determined by hand dynamometer
Exclusion criteria
- Patients > 75 and < 18 years of age - Prognosis or time to transplant < 6 months as determined by the treating clinician - Active heavy alcohol intake - Advanced hepatocellular carcinoma - Lactose intolerance
Outcome results
None listed