A randomized pilot trial of oral branched-chain amino acids in early liver cirrhosis

UMIN ID: UMIN000001360

Registered date:01/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: compensated liver cirrhosis(Child A cirrhosis)
• Date of first enrollment: 1999/01/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients in the BCAA group received a cirrhotic diet supplemented with a Japanese nutritional preparation (LIVACT granules; AJINOMOTO Co., Inc., Tokyo, Japan; 4.15 g BCAA granules per sachet containing 952 mg L-isoleucine, 1904 mg L-leucine, and 1144 mg L-valine) given three times daily. The daily cirrhotic diet consisted of a total calorie intake of 25 to 35 kcal/kg and 1.0 to 1.2 g/kg protein (including 12.45 g/day BCAA in the BCAA group), adjusted to standard body weight (height (m)^2*22) according to the guidelines of the European Society of Parenteral and Enteral Nutrition (ESPEN). All patients received the same dietary instructions throughout the study. All patients completed questionnaires on their diet at 6-month intervals after enrollment.
Patients in the control group received the same dietary instructions without BCAA. All patients completed questionnaires on their diet at 6-month intervals after enrollment.

Outcome(s)

• Primary Outcome: Eligible patients received the assigned treatment for at least 1 year. The primary endpoint of the study was the incidence of complications related to cirrhosis after enrollment. Major cirrhotic complications were defined as the first confirmation of hepatocellular carcinoma (HCC), ascites, esophagogastric varices, or hepatic encephalopathy.
• Secondary Outcome: Secondary endpoints were defined as the receipt of any of the following treatments, which can influence quantitative hepatic reserve markers such as MELD score, CTP score, and CI: (i) albumin infusions for ascites; (ii) endoscopic sclerotherapy/ligation for varices; (iii) open surgery, interventional radiology, or percutaneous therapy for HCC; and (iv) parenteral BCAA for encephalopathy.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Patients were also excluded if they had (i) been receiving albumin infusions at least once per week for 1 month or longer, (ii) a history of oral BCAA supplementation/dietary protein restriction for 6 months or longer, (iii) major cirrhotic complications such as HCC, ascites, esophagogastric varices, or hepatic encephalopathy, or (iv) other non-hepatic major diseases.

Related Information

• Primary Sponsor: Graduate School of Medicine, Osaka City University
• Source(s) of Monetary Support: None