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CompletedNCT01060813Updated Aug 21, 2015

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

An interventional study of Leucine supplements in Cirrhosis, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-21.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cirrhosis

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Keywords

  • cirrhosis
  • exercise
  • leucin
  • glutamine synthetase
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's enrollment of 17 is below the median of 50 across 2,130 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • compensated liver cirrhosis.

Exclusion criteria

Exclusion Criteria:

  • hepatocellular carcinoma,
  • active alcoholism (less than 1 year),
  • decompensated cirrhosis,
  • variceal bleeding less than 3 months,
  • contraindication for exercise.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    Exercise + Leucine

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

    Dietary Supplement: Leucine supplements

  • Active comparator
    Leucine without exercise

    patients will receive leucine 10 g/d po

    Dietary Supplement: Leucine supplements

Interventions

  • Dietary supplementLeucine supplements

    leucine supplements

    Also known as: No other names

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What researchers measure

Primary outcomes

  1. glutamine synthetase activity

    Time frame: three months

Secondary outcomes

  1. quality of life

    Time frame: three months

07

Study locations

1 site
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08041, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01060813
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
German Soriano (Dr. German Soriano Pastor, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau) — Principal investigator
First posted
Feb 2, 2010
Start date
Jan 2010
Primary completion
Jun 2010
Completion
Dec 2010
Last update
Aug 21, 2015

Study contacts

German Soriano, MD, PhD
principal investigator · Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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