Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.
Key facts
- Where
- New Delhi, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07299110, who can take part
Where in India
- Institiute of liver and biliary sciencesNew Delhi, IndiaContact: Dr Ishank Johri, MDTaking people
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- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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Print a page for my doctorTrial details
- Who runs it
- Institute of Liver and Biliary Sciences, India
- Trial code
- NCT07299110
- Record updated
- 31 December 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients; Age (18-70 years); Informed consent to participate in the study.
Exclusion: Receiving rifaximin or lactulose; History of overt HE (West Haven grade II or more); Known egg or dairy allergy; Those on sedatives, antidepressant or anti-psychiatric medication; Diarrhea, SIBO or malabsorptive syndrome; CKD (creatinine >1.5 mg/dL), active infection, GI bleeding in past 2 weeks; Severe anaemia (Hb <7 g/dL) or hypoalbuminemia (<2.0 g/dL); Last Intake <1.5 months; Unable to understand the language or instructions; Hepatocellular Carcinoma; TIPS.