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The Effect Of Late Evening Whey Protein Supplementation On Psychometric Hepatic Encephalopathy Score In Patients With Cirrhosis And Minimal Hepatic Encephalopathy: A Randomized, Double-Blind, Placebo-Controlled Trial

The Effect Of Late Evening Whey Protein Supplementation On Psychometric Hepatic Encephalopathy Score In Patients With Cirrhosis And Minimal Hepatic Encephalopathy: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260601026
Enrollment
32
Registered
2026-06-01
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis Minimal Hepatic Encephalopathy Cirrhosis Minimal Hepatic Encephalopathy Psychometric Hepatic Encephalopathy Scpre Whey protein

Interventions

Fresubin whey protein 22 gram per day for 12 weeks,Maltodextrin 22 gram per day for 12 weeks
Active Comparator Dietary Supplement,Placebo Comparator Dietary Supplement
Whey protein,Maltodextrin

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years with a diagnosis of liver cirrhosis 2. Presence of MHE, defined by PHES score less than or equal -5

Exclusion criteria

Exclusion criteria: 1.History of acute decompensation of cirrhosis within the past 3 months 2. Active alcohol consumption within the past 3 months 3. Active use of psychotropic drugs (antipsychotic, anxiolytic, or antidepressant) 4. History of oral nutritional supplement use within 2 weeks 5. MELD score more than 20 6. Known allergy to whey protein 7. Estimated glomerular filtration rate < 60 mL/min/1.73 m2 8. Presence of active malignancy 9. Pregnant or currently breastfeeding 10. Severe cardiopulmonary or neuropsychological diseases 11. Patients who cannot follow commands or have functional disabilities

Design outcomes

Primary

MeasureTime frame
PHES score 12 weeks PHES score

Secondary

MeasureTime frame
Nutritional status 12 weeks ASM, Handgrip strength, Physcial performance,CTP, MELD score 12 weeks CTP/MELD score,Laboratory marker 12 weeks Pre-albumin, ammonia, IL6, TNF alpha, LPS, LBP,QoL 12 weeks SF 36

Countries

Thailand

Contacts

Public ContactChuti Burana

King Chulalongkorn Memorial Hospital

burana.chuti@gmail.com0818141250

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026