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Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 cirrhosis, especially for those at risk of hepatic encephalopathy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.

• Age (18-70 years).

• Informed consent to participate in the study.

Locations
Other Locations
India
Institiute of liver and biliary sciences
RECRUITING
New Delhi
Contact Information
Primary
Dr Ishank Johri, MD
ishankjohri@gmail.com
01146300000
Backup
Dr Ashok Choudhury, DM
doctor.ashokchoudhury@gmail.com
01146300000
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: whey protein and egg albumen
Each participant will receive two oral protein challenges in a crossover design:~1. Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1~2. Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov