Diet based on animal proteins
OtherΙntervention with a diet based on animal proteins.
NCT Number: NCT07028580
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Agricultural University of Athens, Athens, Attica, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From the first day and 3 months later
Quality of life (QoL) was assessed with the SF-36 questionnaire.
Time frame: From the first day and 3 months later
Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.
Agricultural University of Athens
Other
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
Acronym: HiProPlado
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