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Sponsored by: |
Hospital Universitari Vall d'Hebron Research Institute |
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Information provided by: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT00955500 |
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 |
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Hepatic Encephalopathy |
Dietary Supplement: Branched-chain amino acids Dietary Supplement: Maltodextrin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study |
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 |
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Normal-protein diet: Active Comparator
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).
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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
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Low-protein diet: Active Comparator
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral maltodextrine
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Dietary Supplement: Maltodextrin
30 grams of oral maltodextrin daily
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital de Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Spain, Barcelona | |
Corporació Sanitària Parc Taulí | |
Sabadell, Barcelona, Spain, 08208 |
Principal Investigator: | Juan Córdoba, MD | Hospital Universitari Vall d´Hebron |
Responsible Party: | Hospital Universitari Vall d´Hebron ( Juan Córdoba, MD ) |
Study ID Numbers: | PR(HG)61/2002 |
Study First Received: | July 21, 2009 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00955500 History of Changes |
Health Authority: | Spain: Ministry of Health |
Hepatic encephalopathy Cirrhosis Proteins of the diet Branched-chain amino acids |
Liver Diseases Neurotoxicity Syndromes Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Liver Cirrhosis Brain Diseases Signs and Symptoms Mental Disorders Leucine Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations Hepatic Insufficiency |
Delirium Liver Failure Metabolic Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Brain Diseases, Metabolic |
Liver Diseases Neurotoxicity Syndromes Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Brain Diseases Signs and Symptoms Pathologic Processes Mental Disorders Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure |
Metabolic Diseases Nervous System Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Brain Diseases, Metabolic |