Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jose Luis Calleja

Majadahonda, Madrid, 28222, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cirrhotic patients with sarcopenia in abdominal CT.

Exclusion criteria

chronic renal failure or being on hemodialysis
active hepatitis B or C virus infection
active alcohol abuse
coinfection with human immunodeficiency virus
renal or previous liver transplantation
history of neoplasia requiring chemotherapy or radiotherapy
hepatocellular carcinoma outside of Milan criteria
TIPs
unwillingness to participate in the study.

Treatment and study plan

Branched chain amino acids (BRCA)

Dietary Supplement

They were with BRCA during the day apart of following the standard recommendations

Primary outcomes

Change of muscle mass in patients with sarcopenia

Time frame: 12 weeks

To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Aug 29, 2019
Registry last updated: Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed