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

Not Applicable

Recruiting

• Conditions: Liver Diseases; Cirrhosis, Liver; Sarcopenia; Malnutrition; Cachexia

• Registration Number: NCT07028580
• Lead Sponsor: Agricultural University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2025-07-29
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Laikon General Hospital of Athens; 🇬🇷 Athens, Attica, Greece

Agricultural University of Athens; 🇬🇷 Athens, Attica, Greece