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

F

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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