Whey versus egg white protein: which causes less ammonia rise in alcohol-related decompensated cirrhosis
Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.
This trial will test whether 30 g of whey protein or 30 g of egg white protein causes a smaller rise in blood ammonia and affects minimal hepatic encephalopathy in adults with decompensated alcohol-related cirrhosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi) |
| Trial ID | NCT07299110 on ClinicalTrials.gov |
What this trial studies
This is a crossover pilot in 50 adults with decompensated ethanol-related cirrhosis without overt hepatic encephalopathy. Each participant will receive two standardized 30 g protein challenges—one whey and one egg albumen—24 hours apart, with venous ammonia measured before and at set times after ingestion and minimal hepatic encephalopathy (MHE) testing performed. Whey is rich in branched-chain amino acids and is rapidly absorbed, while egg albumen digests more slowly and is higher in aromatic amino acids, which may increase ammoniagenesis. The crossover design lets each person act as their own control to directly compare postprandial ammonia responses to the two proteins.
Who should consider this trial
Good fit: Adults 18–70 with decompensated ethanol-related cirrhosis who can give informed consent, have no history of overt hepatic encephalopathy, are not on rifaximin or lactulose, and have no egg or dairy allergy.
Not a fit: Patients with overt hepatic encephalopathy, recent GI bleeding or active infection, significant renal impairment, hepatocellular carcinoma, TIPS, current HE medications, or egg/dairy allergy are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, results could help patients and clinicians choose protein supplements that produce less ammonia and reduce the risk or severity of minimal hepatic encephalopathy.
How similar studies have performed: Prior work indicates BCAA-rich proteins like whey may be less ammoniagenic and can help cognitive symptoms in cirrhosis, but direct head-to-head crossover protein-challenge data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Delhi
- Institiute of liver and biliary sciences — New Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Ishank Johri, MD
- Email: ishankjohri@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.