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

NCT07299110 | Recruiting

• 1 other identifier: ILBS-Cirrhosis-74
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decompensated Cirrhosis Ethanol Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

whey protein and egg albumen

EXPERIMENTAL

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

Dietary Supplement: Whey Protein; Dietary Supplement: Egg Albumen

Interventions

Whey Protein DIETARY_SUPPLEMENT

Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1.

whey protein and egg albumen

Egg Albumen DIETARY_SUPPLEMENT

Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2.

whey protein and egg albumen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of overt HE (West Haven grade II or more).
• Last Intake \<1.5 months.
• 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).
• Known egg or dairy allergy.
• Those on sedatives, antidepressant or anti-psychiatric medication.
• Unable to understand the language or instructions.
• Hepatocellular Carcinoma.
• TIPS.
• Receiving rifaximin or lactulose.
• Diarrhea, SIBO or malabsorptive syndrome.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institiute of liver and biliary sciences

New Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Dr Ishank Johri, MD

CONTACT

01146300000; ishankjohri@gmail.com

Dr Ashok Choudhury, DM

CONTACT

01146300000; doctor.ashokchoudhury@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: December 23, 2025
• Study Start: December 12, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

IN (1)