Skip to main content
OpenTrials
Completed

NCT Number: NCT00955500

Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cirrhosis of the liver.
  • Recovery from an episode of hepatic encephalopathy within two months prior to inclusion.
  • 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.

Treatment and study plan

Branched-chain amino acids

Dietary Supplement

30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily

Maltodextrin

Dietary Supplement

30 grams of oral maltodextrin daily

Primary outcomes

  1. Hepatic encephalopathy-free survival

    Time frame: 56 weeks

Secondary outcomes

  1. Overall duration in days of episodic hepatic encephalopathy

    Time frame: 56 weeks

  2. Minimal hepatic encephalopathy assessed by neuropsychological tests

    Time frame: 56 weeks

  3. Health-related quality of life

    Time frame: 56 weeks

  4. Nutritional status

    Time frame: 56 weeks

  5. Liver function

    Time frame: 56 weeks

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Aug 10, 2009
Registry last updated
Aug 10, 2009

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.