An interventional study of Diet based on animal proteins and Diet based on plant proteins. in Liver Diseases, Cirrhosis, Liver and Sarcopenia, sponsored by Agricultural University of Athens. Recruiting at 2 sites in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Agricultural University of Athens · Not applicable, Interventional, and Treatment
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:
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Agricultural University of Athens is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Compared within Liver Cirrhosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Liver Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Control group who were given general instructions for patients with liver disease.
Other: General instructions for patients with liver disease.
Ιntervention with a diet based on animal proteins.
Ιntervention with a diet based on animal proteins.
Α brochure with general instructions was designed for patients with liver disease.
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.
Time frame: From the first day and 3 months later
Quality of life (QoL) assessment
Quality of life (QoL) was assessed with the SF-36 questionnaire.
Time frame: From the first day and 3 months later
Dietary compliance
Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.
Time frame: From the first day and 3 months later
Plan to share: Yes
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Jul 2025, 37 months after the start.
Of 207 non-industry interventional studies with no phase under Liver Cirrhosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 73. This study's planned 37 months is close to that.
Counting every sponsor, half of 216 studies reached it within 32 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Agricultural University of Athens