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

Official 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

Overview

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.

Interventions

• Other Diet based on animal proteins
  Ιntervention with a diet based on animal proteins.
• Other Diet based on plant proteins.
  Ιntervention with a diet based on animal proteins.
• Other General instructions for patients with liver disease.
  Α brochure with general instructions was designed for patients with liver disease.

Primary outcome measures

• Anthropometric measurements [Time frame: From the first day and 3 months later]
• Quality of life (QoL) assessment [Time frame: From the first day and 3 months later]
• Dietary compliance [Time frame: From the first day and 3 months later]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Greece · 2 centers

• Laikon General Hospital of Athens — Athens
• Agricultural University of Athens — Athens

Identifiers

NCT: NCT07028580 · 227 15/4/2022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗