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

Puerta de Hierro University Hospital1 site in 1 country32 target enrollmentAugust 1, 2017

ConditionsSarcopenia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sarcopenia
Sponsor: Puerta de Hierro University Hospital
Enrollment: 32
Locations: 1
Primary Endpoint: Change of muscle mass in patients with sarcopenia
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2017

End Date

August 9, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Puerta de Hierro University Hospital

Responsible Party

Principal Investigator

Jose Luis Calleja

Director. Clinical Research

Puerta de Hierro University Hospital

Eligibility Criteria

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
•unwillingness to participate in the study.

Outcomes

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