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

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.

Study Overview

• Status: Recruiting
• Conditions: Decompensated Cirrhosis Ethanol Related
• Intervention / Treatment: Dietary supplement: Whey Protein; Dietary supplement: Egg Albumen

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Ishank Johri, MD; Phone Number: 01146300000; Email: ishankjohri@gmail.com
• Study Contact Backup: Name: Dr Ashok Choudhury, DM; Phone Number: 01146300000; Email: doctor.ashokchoudhury@gmail.com

Study Locations

• India
  • New Delhi, India, 110070
    • Recruiting
    • Institiute of liver and biliary sciences
    • Contact: Dr Ishank Johri, MD; Phone Number: 01146300000; Email: ishankjohri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.
2. Age (18-70 years).
3. Informed consent to participate in the study.

Exclusion Criteria:

1. History of overt HE (West Haven grade II or more).
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whey protein and egg albumen; Each participant will receive two oral protein challenges in a crossover design: Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1; Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2	Dietary supplement: Whey Protein; Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1.; Dietary supplement: Egg Albumen; Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the effects of whey protein versus egg albumen protein oral challenge in blood ammonia level after 3 hours in decompensated ethanol related cirrhosis.	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the prevalence of minimal hepatic encephalopathy (MHE).	24 hours
To compare the prevalence of MHE in 24 hours following whey protein versus egg albumen protein challenge.	24 hours
Initial lab parameters that predict protein challenge induced MHE.	24 hours
Number of participants with treatment related adverse effects accessed by CTCAE v4.0	24 hours

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Estimated): December 12, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dairy Products; Milk; Dietary Proteins; Milk Proteins; Animal Proteins, Dietary; Whey; Whey Proteins
• Other Study ID Numbers: ILBS-Cirrhosis-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No