Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07299110

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

Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-12-31

50

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Known or newly diagnosed case of decompensated ethanol related cirrhosis
  • Age between 18 and 70 years
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • History of overt hepatic encephalopathy West Haven grade II or higher
  • Last intake less than 1.5 months ago
  • Chronic kidney disease with creatinine over 1.5 mg/dL
  • Active infection or gastrointestinal bleeding in the past 2 weeks
  • Severe anemia with hemoglobin less than 7 g/dL
  • Hypoalbuminemia with albumin less than 2.0 g/dL
  • Known allergy to eggs or dairy
  • Use of sedatives, antidepressants, or psychiatric medications
  • Inability to understand language or instructions
  • Presence of hepatocellular carcinoma
  • Presence of transjugular intrahepatic portosystemic shunt (TIPS)
  • Currently receiving rifaximin or lactulose
  • Diarrhea, small intestinal bacterial overgrowth, or malabsorptive syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institiute of liver and biliary sciences

New Delhi, India, 110070

Actively Recruiting

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Research Team

D

Dr Ishank Johri, MD

CONTACT

D

Dr Ashok Choudhury, DM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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