Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Cirrhosis

Treatments: Dietary Supplement: Leucine supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT01060813

IIBSP-AMI-2009-17

Details and patient eligibility

About

This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• compensated liver cirrhosis.

Exclusion criteria

• hepatocellular carcinoma,
• active alcoholism (less than 1 year),
• decompensated cirrhosis,
• variceal bleeding less than 3 months,
• contraindication for exercise.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Exercise + Leucine

Active Comparator group

Description:

Patients will receive leucine 10 g/d po + exercise for 3 months

Treatment:

Dietary Supplement: Leucine supplements

Leucine without exercise

Active Comparator group

Description:

patients will receive leucine 10 g/d po

Treatment:

Dietary Supplement: Leucine supplements