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IRCT20220426054667N2 IRCT 2023-06-08 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 biochemical and functional indicators of sarcopenia in patients with liver cirrhosis: a randomized controlled trial 2023-06-21 anticipated 50 Complete https://irct.ir/trial/69973 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned to two groups including the intervention group (receiving a diet based on plant and dairy protein) and the control group (receiving a standard isocaloric diet). Randomization will be carried out using a permuted block randomization procedure of size 2, whose random sequence is generated using RAS software. The people of the two groups will be matched in terms of age, gender and severity of malnutrition. 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 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 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the confidentiality of participant information, it is not possible to publish it
public Somayyeh Asghari
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
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 Alley, Naderi St, Keshavarz Boulevard
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 MELD score greater than 18 or Child-Pugh Class C Active gastrointestinal bleeding Serum creatinine above 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 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 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 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. Myostatin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA. 4-metre Gait Speed Test. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: chronometer. Five Times Sit to Stand Test. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Chronometer. Handgrip strength. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Dynamometer. Weight. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Digital scale. Body Mass Index (BMI). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Weight (Kg)/height(m)2. Middle Arm Circumference (MAC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Tape. Triceps skin fold (TSF). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Caliper. Middle Arm Muscle Circumference (MAMC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: MAMC = MAC – (3.1416 × TSF). Ammonia. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit. Total bilirubin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Photometric. Prothrombin time (PT). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit. Model for End-Stage Liver Disease. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Formula: 9.57 × loge (creatinine) + 3.78 × loge (total bilirubin) + 11.2 × loge (INR) + 6.43. Serum creatinine. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Jaafe. International Normalized Ratio (INR). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Formula: INR = [patient PT (s)/MNPT (s)] ISI. Albumin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Special kit. Total protein. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit. Tehran University of Medical Sciences Approved 2023-04-30 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)