Cirrhosis, Liver, Liver Diseases, Malnutrition; Cachexia, Sarcopenia
Conditions
Keywords
malnutrition, plant based diet, protein, sarcopenia, liver disease
Brief 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. 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.
Interventions
OTHERDiet based on animal proteins
Ιntervention with a diet based on animal proteins.
OTHERDiet based on plant proteins.
Ιntervention with a diet based on animal proteins.
OTHERGeneral instructions for patients with liver disease.
Α brochure with general instructions was designed for patients with liver disease.
Sponsors
National and Kapodistrian University of Athens
Aristotle University Of Thessaloniki
Agricultural University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Double Blind randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice.
Exclusion criteria
* Psychopathological illness * Adoption of a vegetarian diet prior to study entry * Hepatonephrotic syndrome requiring protein restriction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) assessment | From the first day and 3 months later | Quality of life (QoL) was assessed with the SF-36 questionnaire. |
| Anthropometric measurements | 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. |
| Dietary compliance | From the first day and 3 months later | Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire. |
Countries
Greece
Outcome results
None listed