Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Liver Cirrhosis

The aim of the study is to compare the implementation of a high-protein diet based on plant-based foods (Group A) with the usual guidelines for liver patients, in which protein needs are met by low-fat animal foods (Group B). The parameters that will be studied concern: 1. Liver function 2. Nutritional status and the risk of malnutrition 3. Body composition, with emphasis on muscle mass 3\. Muscular system functionality and sarcopenia 4. The intestinal microbiome 5. The quality of life of the patients This is a randomized, double-blind intervention study lasting 6 months, during which volunteers will be asked to answer, with the help of the researchers, questionnaires assessing nutritional risk, assessing physical activity and quality of life, and assessing nutritional intake (24-hour food recall and Food Frequency Questionnaire). At the same time, a blood sample will be collected for analysis of inflammatory factors and indicators related to nutritional status (albumin, prealbumin, cholesterol, total iron binding capacity). Body composition will be assessed using the method of anthropometry and dual-energy X-ray absorptiometry (DEXA), and hand dynamometry to assess functionality. The assessment of the microbiome will be performed by saliva collection and/or stool collection. The impact on liver function will be assessed by recording every 3 months a) natriuresis/microalbuminuria (in 24-hour urine collection or urine sample) and the severity of ascites (grade I, II, III), b)ammonia levels and episodes of encephalopathy, c) complications of cirrhosis, such as variceal hemorrhage, encephalopathy, spontaneous bacterial peritonitis and renal dysfunction, d) liver disease severity assessment scores, such as MELD and Child-Pugh scores. The aim of the study is to see if there is a difference in sarcopenia and the values of various biochemical indicators between patients who received plant-based proteins compared to patients who received animal-based proteins.

NCT Number	NCT07028580
Lead Sponsor	Agricultural University of Athens Collaborators: National and Kapodistrian University of Athens, Aristotle University Of Thessaloniki
Conditions	Liver Diseases, Cirrhosis, Liver, Sarcopenia, Malnutrition; Cachexia
Enrollment	100 participants
Start Date	2022-06-15
Primary Completion	2025-07-29 (estimated)
Study Completion	2025-12-29 (estimated)
Updated on ClinicalTrials.gov	2025-06-19