-
Study aim
-
Evaluating the effect of a diet based on vegetable and dairy protein compared to a standard diet on biochemical and functional indicators of sarcopenia in patients with liver cirrhosis
-
Design
-
A randomized, controlled, parallel-group, phase 3 clinical trial on 50 patients.
-
Settings and conduct
-
The intervention will be carried out for 12 weeks on people with liver cirrhosis in specialized gastroenterology clinics in Tehran. Face-to-face meetings will be held once every three weeks. Evaluation of variables at the beginning and end of the study will be done.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Diagnosed liver cirrhosis for at least 6 months, age between 30 and 60 years old, and Willingness to participate in the study.
Exclusion criteria: MELD score >18 or Child-Pugh Class C, Active gastrointestinal bleeding, Serum creatinine >1.5 mg/dl during the last month, Alcohol and tobacco consumption during the last 6 months, Pregnancy and lactation, Suffering from diabetes, pulmonary diseases, psychological disorders, hepatocellular carcinoma, and other cancers, heart failure, acute viral hepatitis, cholestatic cirrhosis, autoimmune cirrhosis, other autoimmune diseases, hyperuricemia, musculoskeletal diseases, Taking corticosteroids and immunosuppressive medications.
-
Intervention groups
-
Subjects in both groups will receive a diet in which energy will be 1.3 times REE, protein will be 1.2g/Kg, and fat and carbohydrates will be 30 and 50-55% of total calories, respectively. The dietary protein source in the intervention group will be based on vegetable and dairy proteins. In the control group, the required protein will be provided from all food groups including bread and grains, vegetables, legumes, meats, eggs, dairy, and nuts.
-
Main outcome variables
-
Muscle function, myostatin, severity of malnutrition, severity of disease