High-protein, plant-dominant diet for people with liver cirrhosis
Official title: Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Sarcopenia, Quality of Life and Metabolic Parameters in Patients With Liver Cirrhosis: A Randomized Clinical Trial
Run by Agricultural University of Athens · NCT07028580 · Data updated 2026-11-12
This 6-month test compares a high-protein, mostly plant-based diet to a usual low-fat animal-protein diet in adults with decompensated cirrhosis who are awaiting kidney transplant to see which better preserves nutrition and muscle.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Agricultural University of Athens Academic / other |
| Locations | 2 sites (Athens, Attica and 1 other locations) |
| Status | Recruiting |
| Started | June 15, 2022 |
| Main results expected | July 29, 2025 |
| Study ends | December 29, 2025 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT07028580 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with decompensated liver cirrhosis who are awaiting kidney transplantation, are not already following a vegetarian diet, and have not previously received specialized dietary advice are the intended participants.
✕Probably not a fit
Patients with psychopathological illness, those already on a vegetarian diet, or those with hepatonephrotic syndrome requiring protein restriction are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, 6-month dietary intervention comparing a high-protein, plant-forward diet to a conventional low-fat animal-protein diet in adults with decompensated cirrhosis awaiting kidney transplantation. Participants are randomized to one of the two diet arms and receive guidance while researchers collect dietary recalls, food-frequency questionnaires, and activity and quality-of-life surveys. Clinical data include blood tests for inflammatory and nutritional markers, body-composition measures with emphasis on muscle mass, functional muscle assessments, and analysis of the intestinal microbiome. Primary outcomes cover liver function, nutritional status and malnutrition risk, body composition and sarcopenia, microbiome changes, and patient-reported quality of life.
Why it matters
Potential benefit: If successful, the high-protein plant-dominant approach could help preserve or increase muscle mass, reduce malnutrition, and improve quality of life and liver-related health in these patients.
How similar studies have gone: Observational studies and small trials have reported promising effects of higher protein intake and plant-focused diets on nutrition and muscle in liver disease, but large randomized data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice. Exclusion Criteria: * Psychopathological illness * Adoption of a vegetarian diet prior to study entry * Hepatonephrotic syndrome requiring protein restriction
Where it's running
-
Laikon General Hospital of Athens
Athens, Attica, Greece Recruiting -
Agricultural University of Athens
Athens, Attica, Greece Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.