Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955500
• Other study ID #: PR(HG)61/2002
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2009
• Last updated: August 7, 2009
• Start date: January 2003
• Est. completion date: January 2009

Study information

• Verified date: August 2009
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

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
• Maltodextrin
30 grams of oral maltodextrin daily

Locations

Country	Name	City	State
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic encephalopathy-free survival		56 weeks	No
Secondary	Overall duration in days of episodic hepatic encephalopathy		56 weeks	No
Secondary	Minimal hepatic encephalopathy assessed by neuropsychological tests		56 weeks	No
Secondary	Health-related quality of life		56 weeks	No
Secondary	Nutritional status		56 weeks	No
Secondary	Liver function		56 weeks	No