Impact of dietary changes on liver cirrhosis outcomes
Impact of Dietary Assessment and Intervention on Outcomes in Liver Cirrhosis Patients
This study is testing if adding branched-chain amino acids to the diet can help people with liver cirrhosis improve their muscle strength, health, and quality of life compared to just regular nutrition support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Dublin) |
| Trial ID | NCT05259930 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of dietary assessment and branched-chain amino acid (BCAA) supplementation on patients with liver cirrhosis. It aims to recruit 100 patients with confirmed cirrhosis and 30 controls to evaluate non-invasive methods for measuring muscle mass and strength, alongside monitoring inflammatory markers. Participants will be divided into two groups: one receiving nutrition support with BCAA and the other receiving nutrition support alone. The study will assess improvements in muscle mass, hospitalization rates, frailty scores, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed cirrhosis and a Child Pugh score of B7 or higher.
Not a fit: Patients with advanced hepatocellular carcinoma, active non-HCC cancer, or severe hepatic encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve muscle mass and clinical outcomes for patients with liver cirrhosis.
How similar studies have performed: Previous studies have shown promising results with amino acid supplementation in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed cirrhosis (clinical or radiological diagnosis using liver biopsy, ultrasound/CT and/or transient elastography, Fibroscan) * Age \> 18 years * Child Pugh score ≥B7 * Active or recent (within the preceding 2 years) cirrhosis-related complication(s): including alcoholic hepatitis, ascites, variceal bleeding, spontaneous bacterial peritonitis, sepsis, encephalopathy, liver-related renal dysfunction, or hepatocellular carcinoma BCLC (Barcelona-Clinic Liver Cancer) stage A or B. Exclusion Criteria: * Active cancer (non-HCC) * Advanced stage hepatocellular carcinoma (BCLC stage C or D) * Pregnancy * Breastfeeding/Lactation * Lack of capacity for informed consent * Hepatic Encephalopathy \> Grade 2 at recruitment * Listed for liver transplant * Consumption of anabolic steroids for purpose of muscle development
Where this trial is running
Dublin
- Royal College of Surgeons in Ireland — Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Ciara O'Connor
- Email: ciaraaoconnor@rcsi.com
- Phone: 01 809 3880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.