Branched-chain amino acids
Dietary Supplement30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily
NCT Number: 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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 56 weeks
Time frame: 56 weeks
Time frame: 56 weeks
Time frame: 56 weeks
Time frame: 56 weeks
Time frame: 56 weeks
Hospital Universitari Vall d'Hebron Research Institute
Other
Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07480096
Brain Diseases, Brain Diseases, Metabolic
Jakarta, DKI Jakarta, Indonesia
View Trial DetailsNCT03796598
Brain Diseases, Brain Diseases, Metabolic
Richmond, Virginia, United States
View Trial DetailsNCT06245473
Brain Diseases, Brain Diseases, Metabolic
Paris, France
View Trial DetailsNCT00287235
Brain Diseases, Brain Diseases, Metabolic
Birmingham, Alabama, United States
View Trial Details