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NCT Number: NCT07028580

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet based on animal proteins

Other

Ιntervention with a diet based on animal proteins.

Diet based on plant proteins.

Other

Ιntervention with a diet based on animal proteins.

General instructions for patients with liver disease.

Other

Α brochure with general instructions was designed for patients with liver disease.

Primary outcomes

  1. Anthropometric measurements

    Time frame: From the first day and 3 months later

    The following parameters will be measured and combined into various equations to evaluate the body weight and body composition of each patient, body weight (kg) , height (m^2) , mid-arm circumference (cm) , skinfolds (mm), dynamometry and biochemical/hematological testing were performed.

  2. Quality of life (QoL) assessment

    Time frame: From the first day and 3 months later

    Quality of life (QoL) was assessed with the SF-36 questionnaire.

  3. Dietary compliance

    Time frame: From the first day and 3 months later

    Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • National and Kapodistrian University of Athens

Registry information

Official study 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

Acronym: HiProPlado

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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