Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Primary Purpose
Hepatic Encephalopathy
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Branched-chain amino acids
Maltodextrin
Sponsored by
About this trial
This is an interventional prevention trial for Hepatic Encephalopathy focused on measuring Hepatic encephalopathy, Cirrhosis, Proteins of the diet, Branched-chain amino acids
Eligibility 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.
Sites / Locations
- Corporació Sanitària Parc Taulí
- Hospital del Mar
- Hospital de Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Normal-protein diet
Low-protein diet
Arm Description
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).
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral maltodextrine
Outcomes
Primary Outcome Measures
Hepatic encephalopathy-free survival
Secondary Outcome Measures
Overall duration in days of episodic hepatic encephalopathy
Minimal hepatic encephalopathy assessed by neuropsychological tests
Health-related quality of life
Nutritional status
Liver function
Full Information
NCT ID
NCT00955500
First Posted
July 21, 2009
Last Updated
August 7, 2009
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00955500
Brief Title
Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Official Title
Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Hepatic encephalopathy, Cirrhosis, Proteins of the diet, Branched-chain amino acids
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal-protein diet
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Low-protein diet
Arm Type
Active Comparator
Arm Description
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral maltodextrine
Intervention Type
Dietary Supplement
Intervention Name(s)
Branched-chain amino acids
Intervention Description
30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
30 grams of oral maltodextrin daily
Primary Outcome Measure Information:
Title
Hepatic encephalopathy-free survival
Time Frame
56 weeks
Secondary Outcome Measure Information:
Title
Overall duration in days of episodic hepatic encephalopathy
Time Frame
56 weeks
Title
Minimal hepatic encephalopathy assessed by neuropsychological tests
Time Frame
56 weeks
Title
Health-related quality of life
Time Frame
56 weeks
Title
Nutritional status
Time Frame
56 weeks
Title
Liver function
Time Frame
56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Córdoba, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
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Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
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