A Phase 4 interventional study of Branched-chain amino acids and Maltodextrin in Hepatic Encephalopathy, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 3 sites in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-08-10.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 4, Interventional, and Prevention
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.
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.
218 studies on the registry are indexed under Hepatic Encephalopathy; 48 are open to participants now.
This study's enrollment of 116 is above the median of 60 across 148 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily
30 grams of oral maltodextrin daily
Hepatic encephalopathy-free survival
Time frame: 56 weeks
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
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute