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Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00955500
First received: July 21, 2009
Last updated: August 7, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall duration in days of episodic hepatic encephalopathy [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Minimal hepatic encephalopathy assessed by neuropsychological tests [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Nutritional status [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
  • Liver function [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

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
Other Name: branched-chain amino acids
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
Other Name: maltodextrin

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955500

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

No publications provided

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
Study First Received: July 21, 2009
Last Updated: August 7, 2009
Health Authority: Spain: Ministry of Health

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:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 23, 2014