Non alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
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
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Pregnancy and breastfeeding History of breast cancer Consuming levothyroxine, warfarin and iron History of allergy to soy and its products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsal Neshatbini Tehrani
Ahvaz University of Medical Sciences
Outcome results
None listed