Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

Sarcopenia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073693
• Other study ID #: 11.17
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 9, 2019

Study information

• Verified date: August 2019
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 9, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cirrhosis
• Sarcopenia

Intervention

Dietary Supplement:
• Branched chain amino acids (BRCA)
They were with BRCA during the day apart of following the standard recommendations

Locations

Country	Name	City	State
Spain	Jose Luis Calleja	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of muscle mass in patients with sarcopenia	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	12 weeks