Liver DiseasesHiProPladoNCT07028580
Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Liver Cirrhosis
A study testing Diet based on animal proteins, Diet based on plant proteins. and General instructions for patients with liver disease. in people with Liver Diseases and Cirrhosis, Liver, run by Agricultural University of Athens at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases, Cirrhosis, Liver, Sarcopenia
- What is being tested?
- Diet based on animal proteins, Diet based on plant proteins. and General instructions for patients with liver disease.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- 15 Jun 2022to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice.
Who cannot join
- Psychopathological illness
- Adoption of a vegetarian diet prior to study entry
- Hepatonephrotic syndrome requiring protein restriction
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Laikon General Hospital of Athens
Athens, Attica, 11527
Evangelos Chologitas, Professor, +30213 206 1643, cholongitas@yahoo.gr
- Recruiting
Agricultural University of Athens
Athens, Attica, 11855
Kalliopi Anna Poulia, Assistant Professor, +30 210 5294668, lpoulia@aua.gr
About this study
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
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:
- Liver function
- Nutritional status and the risk of malnutrition
- Body composition, with emphasis on muscle mass
- Muscular system functionality and sarcopenia 4. The intestinal microbiome 5. The quality of life of the patients
Read more
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.
- Conditions
- Liver Diseases, Cirrhosis, Liver, Sarcopenia, Malnutrition; Cachexia
- Being tested
- Diet based on animal proteins, Diet based on plant proteins., General instructions for patients with liver disease.
- Keywords
- malnutrition, plant based diet, protein, sarcopenia, liver disease
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Sarcopenia, Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet based on animal proteinsOther
Ιntervention with a diet based on animal proteins.
Diet based on plant proteins.Other
Ιntervention with a diet based on animal proteins.
General instructions for patients with liver disease.Other
Α brochure with general instructions was designed for patients with liver disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diet based on plant proteins. |
| Group C (control) | Other | Control group who were given general instructions for patients with liver disease. Receives: Other: General instructions for patients with liver disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first day and 3 months later
Quality of life (QoL) assessment
Quality of life (QoL) was assessed with the SF-36 questionnaire.
Measured: From the first day and 3 months later
Dietary compliance
Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.
Measured: From the first day and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Jun 2022
- Primary completion29 Jul 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kalliopi Anna Poulia, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028580
- Sponsor's protocol ID
- 227 15/4/2022
- Acronym
- HiProPlado
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07028580
- Acronym / sponsor ID
- HiProPlado / 227 15/4/2022
- Conditions
- Liver Diseases, Cirrhosis, Liver, Sarcopenia, Malnutrition; Cachexia
- Keywords
- malnutrition, plant based diet, protein, sarcopenia, liver disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Aristotle University Of Thessaloniki
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Liver function
- Nutritional status and the risk of malnutrition
- Body composition, with emphasis on muscle mass
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Double Blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A (diet with animal protein). | Experimental | Other: Diet based on animal proteinsIn group Α, a diet was designed based on the needs of each individual, based on proteins of animal origin. |
| Group B (diet with plant based protein). | Experimental | Other: Diet based on plant proteins.In group B, a diet was designed based on the needs of each individual, based on proteins of plant origin. |
| Group C (control) | Other | Other: General instructions for patients with liver disease.Control group who were given general instructions for patients with liver disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice.
Key exclusion criteria (3 listed)
- Psychopathological illness
- Adoption of a vegetarian diet prior to study entry
- Hepatonephrotic syndrome requiring protein restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet based on animal proteinsΙntervention with a diet based on animal proteins. | Other | Group A (diet with animal protein). |
| Diet based on plant proteins.Ιntervention with a diet based on animal proteins. | Other | Group B (diet with plant based protein). |
| General instructions for patients with liver disease.Α brochure with general instructions was designed for patients with liver disease. | Other | Group C (control) |
Primary outcome
Anthropometric measurements
Time frame: 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
Time frame: From the first day and 3 months later
Quality of life (QoL) was assessed with the SF-36 questionnaire.
Dietary compliance
Time frame: From the first day and 3 months later
Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet based on animal proteins, Diet based on plant proteins. and General instructions for patients with liver disease. in people with Liver Diseases and Cirrhosis, Liver, run by Agricultural University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (time frame: From the first day and 3 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.