Randomized controlled trial of the combination of exercise therapy and BCAA supplementation for chronic liver diseases

UMIN ID: UMIN000001893

Registered date:01/05/2009

Basic Information

• Health condition(s) or Problem(s) studied: chronic liver disease
• Date of first enrollment: 2009/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Combination of 12g of daily branched-chain amino acid supplementation (Aminofeel)and controlled exercise therapy along with 6 weeks of nutritional support including late evening snack
12g of daily branched-chain amino acid supplementation (Aminofeel) along with 6 weeks of nutritional support including late evening snack
Controlled exercise therapy along with 6 weeks of nutritional support including late evening snack
6 weeks of nutritional support including late evening snack

Outcome(s)

• Primary Outcome: Nutritional status after 6 weeks from the registration
• Secondary Outcome: Symptoms, quality of life of patients and immunological competences after 6 weeks from the registration

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Patients with poor oral intake 2. Pasthistory of allergic reaction to the ingredients of Aminofeel 3.Patients with risky varices for upper GI bleeding 4. Patients of diabetes with poor control of the concentration of blood sugar 5. Patients of hypertention with poor control of blood pressure 6. Patients with history of severe cardiovascular diseases 7.Patients with clinical manifestation of hepatic encephalopathy 8.Patients inappropriate for participating to this study decided by the attending physicians.

Related Information

• Primary Sponsor: Tohoku University
• Source(s) of Monetary Support: Terumo Co.,LTD.