Decompensated Cirrhosis Ethanol Related
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWhey Protein
Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1.
DIETARY_SUPPLEMENTEgg Albumen
Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Contacts
Primary ContactDr Ishank Johri, MD
Backup ContactDr Ashok Choudhury, DM
Outcome results
None listed