The investigation for the improvement of nutrition using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma

UMIN ID: UMIN000001255

Registered date:22/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Liver cirrhosis associated with hepatocellular carcinoma
• Date of first enrollment: 2008/07/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Diet group: Diet therapy alone (30-35kcal/kg/day) during treatments and follow up periods
Aminoreban EN group: Oral supplementation with two pack of Aminoreban EN (one pack during a day, ie at sometime from 10 a.m. to 3 p.m. and other pack at 10 p.m. as late evening snack (LES)) during treatments and follow up periods

Outcome(s)

• Primary Outcome: occurence of the following events: ascites, peripheral edema, bleeding of gastrointerstinal tract, hepatic encephalopathy, others
• Secondary Outcome: SF-36 nutrition status using an indirect calorimeter(RQ) reserved liver function(Alb) BTR Change of blood cell count(WBC, RBC, lymphocyte, Plt)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Extrahepatic metastasis 2. History of anaphylactic reaction for amino acid nutrient 3. Severe renal dysfunction 4. Congenital amino-acid metabolism abnormality 5. Milk allergy

Related Information

• Primary Sponsor: Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
• Source(s) of Monetary Support: None