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IRCT201701162709N40 IRCT 2017-02-19 Vice Chancellor for Research, Iran University of Medical Sciences Effect of soy milk consumption on non-alcoholic fatty liver disease. Effects of soy milk consumption on liver enzymes,lipid profile,glycemic status, markers of inflammation and oxidative stress and hepatic steatosis in non-alcoholic fatty liver patients. 2017-02-23 anticipated 70 Complete https://irct.ir/trial/2551 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Non-alcoholic fatty liver disease. Intervention 1: Control group ) following a 500- calorie deficit diet plan with macronutrients composition of 30 % fat , 15 % protein and 55 % carbohydrate. Intervention 2: Intervention group) The calorie and macronutrients composition of diet is equal to the control group.In this group, one glass of soy milk ( 240 cc ) is replaced with one serving of both starches and fats groups.
public Dr.Farzad Shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) +98 21 8862 2755 farzadshidfar@yahoo.com Iran University of Medical Sciences scientific Dr.Farzad Shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) +98 21 8862 2755 farzadshidfar@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria : patient aged 18- 60 y ; diagnosis of NAFLD in accordance to American Gastroenterological Association guidelines as follows: a) hepatic steatosis confirmed by ultrasonography , b) there are no cause for secondary steatosis such as alcohol consumption, hereditary disorders( e.g. hemochromatosis,wilson’s disease) ,autoimmune diseaseses ,hepatotoxic drugs (e.g. methotrexate , amiodaron, tamoxifen, corticosteroids, valproate and anti-viral drugs) and chronic hepatitis C ; Absence of any other co-disorders including but not limited to other chronic liver diseases (hepatitis), cirrhosis, celiac, diabetes, thyroid disorders, breast cysts, as well as cardiovascular, renal, respiratory ,inflammatory and autoimmune diseases ; Absence of cancer or a history of cancer in patient and his/her first-degree relatives ; BMI of 25 to 40 (kg/m2) ; having no allergy to soy milk ; consuming no nutritional supplements during the last two months ; Taking no anti-inflammatory drugs; hasn’t any history of drug abuse and smoking; no pregnancy or lactation ; willingness to participate and sign an informed written consent. Exclusion criteria: Lack of willingness to be a study participants during the study ; allergy or intolerance to soy milk during the study ; Lack of adherence to soy milk consumption ; existence of medical conditions that require special treatments during the study . 18 years 60 years Both K76.0 Fatty (change of) liver, not elsewhere classified Other Other Control group ) following a 500- calorie deficit diet plan with macronutrients composition of 30 % fat , 15 % protein and 55 % carbohydrate Intervention group) The calorie and macronutrients composition of diet is equal to the control group.In this group, one glass of soy milk ( 240 cc ) is replaced with one serving of both starches and fats groups Liver enzymes (ALT,AST,ALP,GGT). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: colorimetery. Lipid profile (TC,TG,HDL-C). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: enzymatic method. Serum hs-CRP. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: immunoturbidimetry. Insulin sensitivity index (QUICKI). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula. Fasting blood sugar. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: enzymatic method. Serum Insulin. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: Chemiluminescence immunoassay. Malondialdehyde. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: colorimetery. Insulin resistance (HOMA-IR). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula. The β-cell function ( % HOMA-β ). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula. LDL-C. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula. Hepatic steatosis. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: ultrasonography. Systolic blood pressure. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: mercury sphygmomanometer. Diastolic blood pressure. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: mercury sphygmomanometer. Plasma fibrinogen. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: clauss method. Weight. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: Seca scale. Waist circumference. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: elastic tape. Body mass index. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula. Vice Chancellor for Research, Iran University of Medical Sciences Approved 2017-01-16 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway. Tehran Iran (Islamic Republic of)