Study intervention
cirrhosis, ’
CIRRHOSIS, COMPLICATIONS
After the run-in period, patients were randomly assigned in a 1:1 ratio to BCAA or control group. The randomization sequence was generated by computer in block of four and stratified to Child-Pugh A or B. In the BCAA group, patients received 16-week of BCAA supplementation (Aminolaban-oral, Otsuka Pharmaceutical Co. Ltd, Thailand) twice daily. Amoinolaban-oral was orange flavor powder, and patients were advised to dissolve 5 scoops in 180 ml of water and drink in the morning and between 7 and 9 pm. Each serving (50 g, 210 kcal) contains 13.5 g of protein (BCAA: 2.03 g of leucine, 1.76 g of isoleucine, and 1.635 g of valine), 32.4 g of carbohydrate, and 3.5 g of fat. Empty containers were kept and returned at each visit to accurately assess compliance, ≥ 90% adherence was considered adequate to continue with the eligibility. In the control group, there were advised not to take BCAA or any nutritional supplementation during the study period. All patients were continued on standard medical treatment for etiology-specific and complications of cirrhosis. A telephone visit was made every 2 weeks by the study investigators to ensure the patients’ adherence to the study protocol. All patients were followed at the outpatient clinic at week 8 and 16. Clinical and biochemical data, including LFI and body composition were collected at each visit. Throughout the study period, LFI was assessed by the study personnel who were unaware of the treatment arm to reduce possible biases. In addition, participants were asked to record their nutritional intake timing and amount in the paper log provided by the investigators.