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Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

Information source: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatic Encephalopathy

Intervention: Branched-chain amino acids (Dietary Supplement); Maltodextrin (Dietary Supplement)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Universitari Vall d'Hebron Research Institute

Official(s) and/or principal investigator(s):
Juan Córdoba, MD, Principal Investigator, Affiliation: Hospital Vall d'Hebron


The purpose of this study is to compare a normal-protein diet containing branched-chain amino acids to a low-protein diet in patients with non-terminal cirrhosis (MELD < 25) who have developed an episode of hepatic encephalopathy within two months prior to inclusion.

Clinical Details

Official title: Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Hepatic encephalopathy-free survival

Secondary outcome:

Overall duration in days of episodic hepatic encephalopathy

Minimal hepatic encephalopathy assessed by neuropsychological tests

Health-related quality of life

Nutritional status

Liver function

Detailed description: Hepatic encephalopathy is a major complication of cirrhosis associated with poor prognosis and poor quality of life. Appearance of HE occurs in the setting of precipitating factors that increase plasma ammonia. The gastrointestinal tract is the primary source of ammonia, which is produced by enterocytes from glutamine and by colonic bacterial catabolism of nitrogenous sources, such as ingested proteins. This is the rationale for proposing low-protein diet as strategy to reduce ammonia production and as standard diet in patients with cirrhosis and hepatic encephalopathy. However, low-protein diet could cause wasting muscle and predispose to recurrence of hepatic encephalopathy, since muscle is an important site for extrahepatic ammonia removal. Branched-chain amino acids have shown beneficial effects on mental state of patients with chronic hepatic encephalopathy. The possible mechanism of action may be improvement of nutritional status through induction of protein synthesis. However, role of branched-chain amino acids in treatment and prevention of acute hepatic encephalopathy is not established. Administration of a normal-protein diet containing oral branched-chain amino acids may reduce recurrence of hepatic encephalopathy as compared to a low-protein diet.


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


Inclusion Criteria:

- Cirrhosis of the liver.

- Recovery from an episode of hepatic encephalopathy within two months prior to


- Compliance with a standard diet during two weeks prior to inclusion.

Exclusion Criteria:

- End-stage cirrhosis (MELD score > 25).

- Marked cognitive disorder (mini-mental test < 27).

- Non-treatable hepatocarcinoma in accordance with Milan criteria.

- Comorbid conditions with a life expectancy less than 6 months.

- Neurological conditions that difficult assessment of treatment of hepatic

encephalopathy (dementia, encephalitis, severe depression).

- Diseases requiring administration of a specific diet (malabsorption, chronic

diarrhea, chronic pancreatic insufficiency, severe obesity).

- No acceptation of written consent.

Locations and Contacts

Hospital de Sant Pau, Barcelona 08025, Spain

Hospital del Mar, Barcelona 08003, Spain

Corporació Sanitària Parc Taulí, Sabadell, Barcelona 08208, Spain

Additional Information

Starting date: January 2003
Last updated: August 7, 2009

Page last updated: August 23, 2015

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