Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.
NCT ID: NCT07299110
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-12
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Whey Protein
Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1.
Egg Albumen
Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2.
Interventions
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Whey Protein
Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1.
Egg Albumen
Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2.
Eligibility Criteria
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Inclusion Criteria
2. Age (18-70 years).
3. Informed consent to participate in the study.
Exclusion Criteria
2. Last Intake \<1.5 months.
3. CKD (creatinine \>1.5 mg/dL), active infection, GI bleeding in past 2 weeks.
4. Severe anaemia (Hb \<7 g/dL) or hypoalbuminemia (\<2.0 g/dL).
5. Known egg or dairy allergy.
6. Those on sedatives, antidepressant or anti-psychiatric medication.
7. Unable to understand the language or instructions.
8. Hepatocellular Carcinoma.
9. TIPS.
10. Receiving rifaximin or lactulose.
11. Diarrhea, SIBO or malabsorptive syndrome.
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institiute of liver and biliary sciences
New Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Dr Ishank Johri, MD
Role: primary
Other Identifiers
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ILBS-Cirrhosis-74
Identifier Type: -
Identifier Source: org_study_id