Condition: Decompensated Cirrhosis Ethanol Related · Sponsor: Institute of Liver and Biliary Sciences, India
In cirrhosis, altered nitrogen metabolism and reduced hepatic clearance of ammonia contribute to the development of Minimal Hepatic Encephalopathy (MHE)-a subclinical but functionally debilitating condition. While adequate protein intake is essential to prevent sarcopenia in cirrhotic patients, the type of protein consumed can significantly influence postprandial ammonia generation, thereby affecting neurocognitive status. This study investigates the differential ammoniagenic potential of two commonly used high-protein nutritional supplements-Whey protein, which is rich in branched-chain amino acids (BCAAs) and rapidly absorbed, and egg albumen protein, which is slower digesting and higher in aromatic amino acids (AAAs), potentially more ammoniagenic. In a crossover pilot design, 50 patients with decompensated ethanol-related cirrhosis will undergo two separate standardized protein challenges with 30g of each protein, spaced 24 hours apart. Venous ammonia levels and MHE parameters (via PHES/Stroop test) will be recorded pre- and 3 hours post-challenge. The primary objective is to compare the change in blood ammonia between the two protein types. Secondary objectives include assessing MHE induction or worsening, and analysing the correlation between ammonia changes and cognitive decline. By directly comparing the metabolic and neurocognitive response to distinct protein sources, this study will help inform safer dietary practices and refine nutritional supplementation in c…
This description comes directly from the study's public registry record.
Dr Ishank Johri, MD · 01146300000 · ishankjohri@gmail.com
Dr Ashok Choudhury, DM · 01146300000 · doctor.ashokchoudhury@gmail.com
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| Institiute of liver and biliary sciences | New Delhi, India | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07299110