| Registry | NCT07299110 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India (Other) |
| Conditions | Decompensated Cirrhosis Ethanol Related |
| Interventions | Whey Protein, Egg Albumen (Dietary supplement) |
| Dates | start 2025-12-12 (estimated), primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2025-12-23, last updated 2025-12-31 |
| Locations | 1 site in India |
Related Papers Related Patents Related Grants Related Experts
All trials for Decompensated Cirrhosis Ethanol Related All trials of Whey Protein All trials of Egg Albumen
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| whey protein and egg albumen | Experimental | Dietary Supplement: Whey Protein; Dietary Supplement: Egg Albumen | 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 |
Sex: All, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Institiute of liver and biliary sciences | New Delhi | India | Recruiting |