]>
IRCT20220426054667N3 IRCT 2023-07-02 Tehran University of Medical Sciences The effect of a diet based on vegetable and dairy protein in patients with liver cirrhosis The effect of a diet based on vegetable and dairy protein on serum levels of inflammatory biomarkers and oxidative stress in patients with liver cirrhosis: a randomized controlled trial 2023-06-21 anticipated 50 Complete https://irct.ir/trial/69983 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to two groups using permuted block randomization with size 2, whose random sequence is generated using RAS software, including the intervention group (receiving a diet based on vegetable and dairy protein) and the control group (receiving a standard isocaloric diet). N/A Liver Cirrhosis. Intervention 1: Intervention group: A diet based on vegetable and dairy protein. Based on the latest guidelines, in this diet, energy will be calculated 1/3 times REE (using the Harris-Benedict equation), protein will be 1/2 gram per kilogram of body weight, fat will be 30% of total calories, and carbohydrate will be 50-55% of total calories. Then, the required amounts of each food group will be determined, and based on that, a menu of 3 meals and 4 snacks will be prepared and presented to the patient. Patients will follow the prescribed diet for 12 weeks. Patients also will be educated about food alternatives. The protein requirement in this diet will be provided from bread and cereals, vegetables, legumes, soy and soy milk, nuts, and dairy products. Intervention 2: Control group: Standard diet. Based on the latest guidelines, in this diet, energy will be calculated 1/3 times REE (using the Harris-Benedict equation), protein will be 1/2 gram per kilogram of body weight, fat will be 30% of total calories, and carbohydrate will be 50-55% of total calories. Then, the required amounts of each food group will be determined, and based on that, a menu of 3 meals and 4 snacks will be prepared and presented to the patient. Patients will follow the prescribed diet for 12 weeks. Patients also will be educated about food alternatives. The protein requirement in this diet will be provided from bread and cereals, vegetables, legumes, all kinds of meat, eggs, dairy, and nuts. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of the participants' information, it is not possible to publish it
public Somayyeh Asghari
NO. 44., Shahid Hojjat Doost Ave., Naderi St., Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 asghari.nut@gmail.com Tehran University of Medical Sciences scientific Somayyeh Asghari
No. 44, Shahid Hojjat Doost Ave., Naderi St., Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 asghari.nut@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having liver cirrhosis with a doctor's diagnosis for at least 6 months Age range from 30 to 60 years Willingness to participate in the study 30 years 60 years Both Model for End-Stage Liver Disease (MELD) score greater than 18 or Child-Pugh Class C Active gastrointestinal bleeding Serum creatinine above 1.5 mg/dl during the last month Consumption of alcohol and tobacco 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 K74.6 Other and unspecified cirrhosis of liver Treatment - Other Treatment - Other Intervention group: A diet based on vegetable and dairy protein. Based on the latest guidelines, in this diet, energy will be calculated 1/3 times REE (using the Harris-Benedict equation), protein will be 1/2 gram per kilogram of body weight, fat will be 30% of total calories, and carbohydrate will be 50-55% of total calories. Then, the required amounts of each food group will be determined, and based on that, a menu of 3 meals and 4 snacks will be prepared and presented to the patient. Patients will follow the prescribed diet for 12 weeks. Patients also will be educated about food alternatives. The protein requirement in this diet will be provided from bread and cereals, vegetables, legumes, soy and soy milk, nuts, and dairy products. Control group: Standard diet. Based on the latest guidelines, in this diet, energy will be calculated 1/3 times REE (using the Harris-Benedict equation), protein will be 1/2 gram per kilogram of body weight, fat will be 30% of total calories, and carbohydrate will be 50-55% of total calories. Then, the required amounts of each food group will be determined, and based on that, a menu of 3 meals and 4 snacks will be prepared and presented to the patient. Patients will follow the prescribed diet for 12 weeks. Patients also will be educated about food alternatives. The protein requirement in this diet will be provided from bread and cereals, vegetables, legumes, all kinds of meat, eggs, dairy, and nuts. Weight. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Digital scale. Height. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Stadiometer. Body Mass Index (BMI). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Body weight (kilogram) divided by the square of height (meter). Mid Arm Circumference (MAC). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Tape. Triceps skin fold (TSF). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Caliper. Middle Arm Muscle Circumference (MAMC). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: MAC – (3.1416 × TSF) formula. Interleukin 6. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Tumor necrosis factor alpha (TNF-α). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. High-sensitivity C-reactive protein (hsCRP). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Immunoturbidometry. Malondialdehyde (MDA). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity (TAC). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Total bilirubin. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Photometric. Prothrombin time (PT). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Biochemical kit. Model for End-Stage Liver Disease score. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: The Model for End-Stage Liver Disease score is calculated using serum bilirubin, serum creatinine, and International Normalized Ratio (INR) and is given by the formula: 9.57 × loge (creatinine) + 3.78 × loge (total bilirubin) + 11.2 × loge (International Normalized Ratio) + 6.43. Total oxidant status (TOS). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Creatinine. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Jaafe/colorimetric. International Normalized Ratio (INR). Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: [patient PT (s)/MNPT (s)] ISI Formula. Tehran University of Medical Sciences Approved 2023-04-19 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)