Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Liver Cirrhosis
NCT ID: NCT07028580
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-06-15
2025-12-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A (diet with animal protein).
In group Α, a diet was designed based on the needs of each individual, based on proteins of animal origin.
Diet based on animal proteins
Ιntervention with a diet based on animal proteins.
Group B (diet with plant based protein).
In group B, a diet was designed based on the needs of each individual, based on proteins of plant origin.
Diet based on plant proteins.
Ιntervention with a diet based on animal proteins.
Group C (control)
Control group who were given general instructions for patients with liver disease.
General instructions for patients with liver disease.
Α brochure with general instructions was designed for patients with liver disease.
Interventions
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Diet based on animal proteins
Ιntervention with a diet based on animal proteins.
Diet based on plant proteins.
Ιntervention with a diet based on animal proteins.
General instructions for patients with liver disease.
Α brochure with general instructions was designed for patients with liver disease.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Adoption of a vegetarian diet prior to study entry
* Hepatonephrotic syndrome requiring protein restriction
18 Years
80 Years
ALL
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Aristotle University Of Thessaloniki
OTHER
Agricultural University of Athens
OTHER
Responsible Party
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Kalliopi Anna Poulia
Assistant Professor in Clinical Dietetics
Locations
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Laikon General Hospital of Athens
Athens, Attica, Greece
Agricultural University of Athens
Athens, Attica, Greece
Countries
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Facility Contacts
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Other Identifiers
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227 15/4/2022
Identifier Type: -
Identifier Source: org_study_id
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