Decompensated Cirrhosis Ethanol RelatedNCT07299110
Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.
A study testing Whey Protein and Egg Albumen in people with Decompensated Cirrhosis Ethanol Related, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decompensated Cirrhosis Ethanol Related
- What is being tested?
- Whey Protein and Egg Albumen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 12 Dec 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.
- Age (18-70 years).
- Informed consent to participate in the study.
Who cannot join
- 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).
- Known egg or dairy allergy.
- Those on sedatives, antidepressant or anti-psychiatric medication.
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- Unable to understand the language or instructions.
- Hepatocellular Carcinoma.
- TIPS.
- Receiving rifaximin or lactulose.
- Diarrhea, SIBO or malabsorptive syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institiute of liver and biliary sciences
New Delhi, 110070
Dr Ishank Johri, MD, 01146300000, ishankjohri@gmail.com
About this study
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.
Read more
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
- Decompensated Cirrhosis Ethanol Related
- Being tested
- Whey Protein, Egg Albumen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinDietary supplement
Whey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1.
Egg AlbumenDietary supplement
Egg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2.
| Study group | Role | What they receive |
|---|---|---|
| whey protein and egg albumen | Experimental | 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 Receives: Dietary Supplement: Whey Protein; Dietary Supplement: Egg Albumen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
To determine the prevalence of minimal hepatic encephalopathy (MHE).
Measured: 24 hours
To compare the prevalence of MHE in 24 hours following whey protein versus egg albumen protein challenge.
Measured: 24 hours
Initial lab parameters that predict protein challenge induced MHE.
Measured: 24 hours
Number of participants with treatment related adverse effects accessed by CTCAE v4.0
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start12 Dec 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Cirrhosis Ethanol RelatedStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299110
- Sponsor's protocol ID
- ILBS-Cirrhosis-74
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.
- ClinicalTrials.gov ID
- NCT07299110
- Acronym / sponsor ID
- ILBS-Cirrhosis-74
- Conditions
- Decompensated Cirrhosis Ethanol Related
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 12 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whey protein and egg albumen | Experimental | Dietary Supplement: Whey Protein, Dietary Supplement: Egg AlbumenEach 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.
- Age (18-70 years).
- Informed consent to participate in the study.
Key exclusion criteria (11 listed)
- 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).
- Known egg or dairy allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey ProteinWhey Protein Challenge: 30g of whey protein in 200-250 mL water on Day 1. | Dietary supplement | whey protein and egg albumen |
| Egg AlbumenEgg Albumen Challenge: 30g of egg albumen protein in 200-250 mL water on Day 2. | Dietary supplement | whey protein and egg albumen |
Primary outcome
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
4 secondary outcomes
To determine the prevalence of minimal hepatic encephalopathy (MHE).
Time frame: 24 hours
To compare the prevalence of MHE in 24 hours following whey protein versus egg albumen protein challenge.
Time frame: 24 hours
Initial lab parameters that predict protein challenge induced MHE.
Time frame: 24 hours
Number of participants with treatment related adverse effects accessed by CTCAE v4.0
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Decompensated Cirrhosis Ethanol Related
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A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein and Egg Albumen in people with Decompensated Cirrhosis Ethanol Related, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ishank Johri, MD (01146300000, ishankjohri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.