We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955500
First Posted: August 10, 2009
Last Update Posted: August 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
  Purpose
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.

Condition Intervention Phase
Hepatic Encephalopathy Dietary Supplement: Branched-chain amino acids Dietary Supplement: Maltodextrin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Hepatic encephalopathy-free survival [ Time Frame: 56 weeks ]

Secondary Outcome Measures:
  • Overall duration in days of episodic hepatic encephalopathy [ Time Frame: 56 weeks ]
  • Minimal hepatic encephalopathy assessed by neuropsychological tests [ Time Frame: 56 weeks ]
  • Health-related quality of life [ Time Frame: 56 weeks ]
  • Nutritional status [ Time Frame: 56 weeks ]
  • Liver function [ Time Frame: 56 weeks ]

Enrollment: 116
Study Start Date: January 2003
Study Completion Date: January 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal-protein diet
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams).
Dietary Supplement: Branched-chain amino acids
30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily
Active Comparator: Low-protein diet
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral maltodextrine
Dietary Supplement: Maltodextrin
30 grams of oral maltodextrin daily

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955500


Locations
Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Juan Córdoba, MD Hospital Vall d'Hebron
  More Information

Responsible Party: Juan Córdoba, MD, Hospital Universitari Vall d´Hebron
ClinicalTrials.gov Identifier: NCT00955500     History of Changes
Other Study ID Numbers: PR(HG)61/2002
First Submitted: July 21, 2009
First Posted: August 10, 2009
Last Update Posted: August 10, 2009
Last Verified: August 2009

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Hepatic encephalopathy
Cirrhosis
Proteins of the diet
Branched-chain amino acids

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases


To Top