NCT07028580 Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Liver Cirrhosis
| NCT ID | NCT07028580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Agricultural University of Athens |
| Condition | Liver Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2025-07-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-06-15 with a primary completion date of 2025-07-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07028580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07028580 currently recruiting?
Yes, NCT07028580 is actively recruiting participants. Visit ClinicalTrials.gov or contact Agricultural University of Athens to inquire about joining.
Where is the NCT07028580 trial being conducted?
This trial is being conducted at Athens, Greece, Athens, Greece.
Who is sponsoring the NCT07028580 clinical trial?
NCT07028580 is sponsored by Agricultural University of Athens. The trial plans to enroll 100 participants.