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

NCT07028580 — Not applicable, Recruiting, 100 participants, Agricultural University of Athens

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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

Registry	NCT07028580, acronym HiProPlado
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	100 (Estimated)
Sponsor	Agricultural University of Athens (Other); collaborators: National and Kapodistrian University of Athens, Aristotle University Of Thessaloniki
Conditions	Liver Diseases, Cirrhosis, Liver, Sarcopenia, Malnutrition; Cachexia
Interventions	Diet based on animal proteins, Diet based on plant proteins., General instructions for patients with liver disease. (Other)
Dates	start 2022-06-15, primary completion 2025-07-29 (estimated), completion 2025-12-29 (estimated), first posted 2025-06-19, last updated 2025-06-19
Locations	2 sites in Greece

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group A (diet with animal protein).	Experimental	Other: Diet based on animal proteins	In group Α, a diet was designed based on the needs of each individual, based on proteins of animal origin.
Group B (diet with plant based protein).	Experimental	Other: Diet based on plant proteins.	In group B, a diet was designed based on the needs of each individual, based on proteins of plant origin.
Group C (control)	Other	Other: General instructions for patients with liver disease.	Control group who were given general instructions for patients with liver disease.

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.

+Outcome measures

Primary outcomes

Anthropometric measurements [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.
Quality of life (QoL) assessment [From the first day and 3 months later]: Quality of life (QoL) was assessed with the SF-36 questionnaire.
Dietary compliance [From the first day and 3 months later]: Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (2)

Facility	City	Country	Status
Laikon General Hospital of Athens	Athens, Attica	Greece	Recruiting
Agricultural University of Athens	Athens, Attica	Greece	Recruiting