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NCT Number: NCT07299110

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institiute of liver and biliary sciences

New Delhi, 110070, India

Location status: Recruiting

Location contact

Dr Ishank Johri, MD

CONTACT

[email protected]

01146300000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Whey Protein

Dietary Supplement

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

Egg Albumen

Dietary Supplement

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

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.

    Time frame: 24 hours

Secondary outcomes

  1. To determine the prevalence of minimal hepatic encephalopathy (MHE).

    Time frame: 24 hours

  2. To compare the prevalence of MHE in 24 hours following whey protein versus egg albumen protein challenge.

    Time frame: 24 hours

  3. Initial lab parameters that predict protein challenge induced MHE.

    Time frame: 24 hours

  4. Number of participants with treatment related adverse effects accessed by CTCAE v4.0

    Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Ashok Choudhury, DM

CONTACT

[email protected]

01146300000

Dr Ishank Johri, MD

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.