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IRCT20220801055597N1 IRCT 2022-09-20 Ahvaz University of Medical Sciences Effect of soy isoflavones in non alcoholic fatty liver disease Effects of soy isoflavones on metabolic profile, liver enzymes, hepatic fibrosis, inflammatory markers and total antioxidant capacity in patients with non-alcoholic fatty liver disease, double blind randomized clinical trial 2022-09-24 anticipated 50 Complete https://irct.ir/trial/65095 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly assigned to either soy isoflavone or placebo groups. Stratified Blocked Randomization method is used to randomly assign patients to two groups. The size of the blocks will be 4 and matching will be done based on gender and menopause status in women, Blinding description: This is a double-blind study. For this purpose, at the start of the study, the cans containing soy isoflavone supplements or placebo are coded as A and B by a third party (a person other than the researchers) so that the researchers and patients do not know the type of supplements received by each group. 3 Non alcoholic fatty liver disease. Intervention 1: Intervention group: Patients in the soy isoflavone group will receive two Soyagol tablets per day with breakfast and dinner for 12 weeks. Soyagol supplement in each tablet contains 50 mg of soy isoflavones, of which 20 to 27 mg is genistein and the rest are other soy isoflavones. This supplement is produced and supplied by Gol Daru herbal pharmaceutical company located in Isfahan city ,Iran. Intervention 2: Control group: Patients in the placebo group will receive two placebo tablets per day containing starch , which are completely similar in shape and size to soy isoflavone supplements and are produced by the same pharmaceutical company (Gol Daru) that supplies Soygol supplements. 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 This study has not yet been started. Preferably, I will make a decision in this regard after finishing it
public Asal Neshatbini Tehrani
Unit 7, No16, Corner of Madaran St, Nezamiye Ganjavi St, Abbaspour Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1434793388 +98 21 8608 1522 asalnt@yahoo.com Ahvaz University of Medical Sciences scientific Asal Neshatbini Tehrani
Unit 7, No 16, Corner of Madaran St, Nezamiye Ganjavi St, Abbaspour Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1434793388 +98 21 8878 2068 asalnt@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 18-75 years old Willingness to participate in study The concentration of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) shall be more than 1.5 fold of the maximum normal level. With evidence of non alcoholic fatty liver disease in Fibroscan (CAP score>260) Without a history of alcohol consumption or consuming alcohol less than 10 grams per day in women and less than 20 grams per day in men. Not taking drugs that affect blood lipids, blood sugar and blood pressure, vitamin E and ursodioxycholic acid (UDCA) and hepatotoxic drugs such as phenytoin, amoxifen, lithium, methotrexate, amiodarone, tamoxifen, corticosteroids, valproate, antiviral drugs, etc. .. Without a history of other diseases, chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, autoimmune diseases, cancer and hereditary disorders affecting the liver (iron or copper storage disease , etc.). Without a history of celiac disease, diabetes, cardiovascular diseases, lung disease, digestive disease affecting food absorption and kidney disease. Without a history of weight loss surgery in the past year or a history of adherence to a weight loss diet in the last 6 months Without a history of thyroid disorder Not taking fiber and soy supplements in the last 3 months Without a history of smoking (cigarettes and other tobacco products) Not regular consumption of soy or soy products in the diet (regular consumption means: consuming more than 30 grams (more than 2 tablespoons) per month) Without a history of liver cirrhosis or not being classified in F4 group 18 years 75 years Both Pregnancy and breastfeeding History of breast cancer Consuming levothyroxine, warfarin and iron History of allergy to soy and its products K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients in the soy isoflavone group will receive two Soyagol tablets per day with breakfast and dinner for 12 weeks. Soyagol supplement in each tablet contains 50 mg of soy isoflavones, of which 20 to 27 mg is genistein and the rest are other soy isoflavones. This supplement is produced and supplied by Gol Daru herbal pharmaceutical company located in Isfahan city ,Iran. Control group: Patients in the placebo group will receive two placebo tablets per day containing starch , which are completely similar in shape and size to soy isoflavone supplements and are produced by the same pharmaceutical company (Gol Daru) that supplies Soygol supplements. The level of liver enzymes, the level of liver fibrosis. Timepoint: At the beginning of the study and at the end of the twelfth week. Method of measurement: Using a blood test for measuring the level of liver enzymes, using a Fibroscan device for measuring the level of liver fibrosis. Metabolic profile (height, weight, waist circumference, hip circumference, waist to hip ratio, BMI), systolic and diastolic blood pressure, total cholesterol level, LDL, HDL, triglyceride, glucose and insulin concentration, insulin resistance (HOMA) -IR), insulin sensitivity. Timepoint: At the beginning and at the end of the study. Method of measurement: Using a tape meter to measure height, waist circumference and hip circumference, using a digital scale to measure weight, using a digital sphygmomanometer to measure blood pressure and using a blood test to measure blood fat and blood sugar . FGF-21 and Fetuin A hepatokines. Timepoint: At the beginning and at the end of the study. Method of measurement: Blood test. Serum total antioxidant capacity. Timepoint: At the beginning and at the end of the study. Method of measurement: Using blood test. Ahvaz University of Medical Sciences Approved 2022-08-01 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Unit 7, No 16, Corner of Madaran St, Nezamiye Ganjavi St, Abbaspour Sq, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)