Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07028580

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

Led by Agricultural University of Athens · Updated on 2025-06-19

100

Participants Needed

2

Research Sites

184 weeks

Total Duration

On this page

Sponsors

A

Agricultural University of Athens

Lead Sponsor

N

National and Kapodistrian University of Athens

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice.
Not Eligible

You will not qualify if you...

  • Psychopathological illness
  • Adoption of a vegetarian diet prior to study entry
  • Hepatonephrotic syndrome requiring protein restriction

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Laikon General Hospital of Athens

Athens, Attica, Greece, 11527

Actively Recruiting

2

Agricultural University of Athens

Athens, Attica, Greece, 11855

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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