Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

High-fiber High-fiber Diet and Branched Chain Aminoacids. Impact on Nutritional Status and Complications in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023229
• Other study ID #: Enterex01
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2013
• Last updated: December 23, 2013
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2013
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines.

We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B

Exclusion Criteria:

Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Dietary Supplement:
• Branched-chain aminoacids

Other:
• High-fiber high protein diet

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico city

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional status	Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference	3 months follow-up	No
Other	Nutritional status	Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference	6 months follow-up	No
Other	Hepatic encephalopathy		6 months follow-up	No
Primary	Nutritional status	Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference	At time of recruitment	No
Secondary	Hepatic Encephalopathy		At time of recruitment	No