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

NCT07028580 | Recruiting

• 1 other identifier: 227 15/4/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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. 1.Liver function
2. 2.Nutritional status and the risk of malnutrition
3. 3.Body composition, with emphasis on muscle mass

Conditions

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

Keywords

malnutrition; plant based diet; protein; sarcopenia; liver disease

Outcome Measures

Primary Outcomes (3)

• Anthropometric measurements

  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.

  From the first day and 3 months later

• Quality of life (QoL) assessment

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

  From the first day and 3 months later

• Dietary compliance

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

  From the first day and 3 months later

Study Arms (3)

Group A (diet with animal protein).

EXPERIMENTAL

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

Other: Diet based on animal proteins

Group B (diet with plant based protein).

EXPERIMENTAL

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

Other: Diet based on plant proteins.

Group C (control)

OTHER

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

Other: General instructions for patients with liver disease.

Interventions

Diet based on animal proteins OTHER

Ιntervention with a diet based on animal proteins.

Group A (diet with animal protein).

Diet based on plant proteins. OTHER

Ιntervention with a diet based on animal proteins.

Group B (diet with plant based protein).

General instructions for patients with liver disease. OTHER

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

Group C (control)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice.

You may not qualify if:

• Psychopathological illness
• Adoption of a vegetarian diet prior to study entry
• Hepatonephrotic syndrome requiring protein restriction

Sponsors & Collaborators

• Agricultural University of Athens: lead
• National and Kapodistrian University of Athens: collaborator
• Aristotle University Of Thessaloniki: collaborator

Study Sites (2)

Laikon General Hospital of Athens

Athens, Attica, 11527, Greece

RECRUITING

Agricultural University of Athens

Athens, Attica, 11855, Greece

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis; Sarcopenia; Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Thinness

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Clinical Dietetics

Model Details: Double Blind randomized clinical trial

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: June 19, 2025
• Study Start: June 15, 2022
• Primary Completion: July 29, 2025
• Study Completion: December 29, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (2)