Even protein distribution plus exercise for people awaiting liver transplant
Evaluation of Protein Distribution Optimization With Exercise Regimen on Nutritional Status, Body Composition and Functional Status in Patients Awaiting Liver Transplantation: The POWER-LT Randomized Clinical Trial
This trial tests whether spreading daily protein evenly and combining it with a 12-week exercise program improves nutrition, muscle mass, and function in people waiting for a liver transplant compared with uneven protein timing or usual advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Agricultural University of Athens Academic / other |
| Locations | 2 sites (Athens, Attica and 1 other locations) |
| Trial ID | NCT07561138 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls liver transplant candidates and assigns them to one of three 12-week approaches: an even protein distribution diet plus supervised exercise, a skewed protein distribution diet plus the same exercise program, or standard dietary and physical activity advice. Primary outcomes include nutritional status, body composition, and functional status, while secondary outcomes cover anthropometry, laboratory parameters, quality of life, disease severity, complications, and mortality. For participants who undergo transplantation, the study will also record postoperative outcomes such as ICU and hospital length of stay, ventilation duration, complications, readmissions, reoperations, and mortality. Interventions are delivered at clinical sites in Athens with regular follow-up visits and objective measures of muscle and function.
Who should consider this trial
Good fit: Adults with end-stage liver disease or cirrhosis who are referred for or listed for liver transplantation, have an expected wait of at least three months, have not received prior formal dietary advice, can safely exercise, and can provide informed consent are ideal candidates.
Not a fit: Patients with exercise contraindications (for example recent variceal bleeding, severe encephalopathy, refractory ascites), chronic kidney disease requiring protein restriction, very short expected wait or life expectancy under three months, pregnancy, or inability to adhere to the program are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could strengthen nutrition and muscle mass before transplant and potentially reduce postoperative complications and shorten recovery.
How similar studies have performed: Even protein distribution has been shown to boost muscle protein synthesis in healthy adults and exercise prehabilitation has benefited other surgical populations, but randomized data specifically in end-stage liver disease are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture * Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation * No prior formal dietary advice Exclusion Criteria: * Age \< 18 years old * Estimated waiting time for liver transplantation \< 3 months * Estimated life expectancy \< 3 months * Chronic kidney disease requiring protein restriction * Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.) * Unstable or severe psychiatric disorder * Pregnancy or lactation * Inability to provide written informed consent
Where this trial is running
Athens, Attica and 1 other locations
- Laiko General Hospital of Athens — Athens, Attica, Greece (Recruiting)
- Agricultural University of Athens — Athens, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Kalliopi Anna Poulia
- Email: lpoulia@aua.gr
- Phone: +30 2105294668
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.