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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.

Age (18-70 years).

Informed consent to participate in the study.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: whey protein and egg albumenExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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