compensated liver cirrhosis(Child A cirrhosis)
Conditions
Interventions
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
Sponsors
Graduate School of Medicine, Osaka City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients had to have (i) an age of 20 to 75 years, (ii) Child class A cirrhosis, and (iii) hepatitis C virus, hepatitis B virus, or alcohol-related cirrhosis.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactEtsushi Kawamura
Graduate School of Medicine, Osaka City University Departments of Nuclear Medicine
Outcome results
None listed