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NCT07028580: HiProPlado
Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Liver Cirrhosis
NA trial testing Diet based on animal proteins in Liver Diseases in 100 participants. Currently enrolling.
29 July 2025
Quick facts
| Lead sponsor | Agricultural University of Athens |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 15 June 2022 |
| Primary completion | 29 July 2025 |
| Estimated completion | 29 December 2025 |
| Sites | 2 locations across Greece |
Drugs / interventions tested
- Diet based on animal proteins
- Diet based on plant proteins.
- General instructions for patients with liver disease.
Conditions studied
- Liver Diseases — all drugs for Liver Diseases →
- Cirrhosis, Liver — all drugs for Cirrhosis, Liver →
- Sarcopenia — all drugs for Sarcopenia →
- Malnutrition; Cachexia — all drugs for Malnutrition; Cachexia →
Sponsor
Agricultural University of Athens
Who can join
Adults 18 to 80, any sex, with Liver Diseases or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07028580
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Agricultural University of Athens trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07028580 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Agricultural University of Athens
- Last refreshed: 19 June 2025
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