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

Agricultural University of Athens

Status: Enrolling

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

Treatments: Other: Diet based on plant proteins.; Other: General instructions for patients with liver disease.; Other: Diet based on animal proteins

Study type: Interventional

Funder types: Other

Identifiers

NCT07028580

227 15/4/2022

Details and patient eligibility

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

4. 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Group A (diet with animal protein).

Experimental group

Description:

In group Α, a diet was designed based on the needs of each individual, based on proteins of animal origin.

Treatment:

Other: Diet based on animal proteins

Group B (diet with plant based protein).

Experimental group

Description:

In group B, a diet was designed based on the needs of each individual, based on proteins of plant origin.

Treatment:

Other: Diet based on plant proteins.

Group C (control)

Other group

Description:

Control group who were given general instructions for patients with liver disease.

Treatment:

Other: General instructions for patients with liver disease.