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IRCT201111022709N20 IRCT 2011-12-26 Vice-chancellor for Research, Tehran University of Medical Sciences " effects of Olive Oil in non-alcoholic fatty liver disease patients" Effects of Extra Virgin Olive Oil on Serum Hepatic enzymes ،Insulin resistance، Lipoproteins، TNFα ، Anthropometric measurments and Esteatosis severity in Non – alcoholic Fatty Liver Patients Whit Loss Weight Diet 2011-11-22 anticipated 50 Complete https://irct.ir/trial/2533 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A non-alcoholic fatty liver. Intervention 1: intervention group :Extra Virgin Olive Oil, 20% of total daily energy requirement olive will be replaced with usual daily consumption of oil for every patients for 12 weeks. Intervention 2: control group :( not application )20% of total daily energy requirement from usual daily consumption of oil for 12 weeks.
public Dr Farzad Shidfar
Number 60, Alvand street, Argentina square, Tehran
Tehran Iran (Islamic Republic of) 1516846515 +98 21 8877 9118 farzadshidfar@yahoo.com Faculty of Public Health of Tehran University of Medical Sciences scientific Dr Farzad Shidfar
Number 60, Alvand street, Argentina square, Tehran
Tehran Iran (Islamic Republic of) 1516846515 +98 21 8877 9118 farzadshidfar@yahoo.com Faculty of Public Health of Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: signing written informed consent, age between 20and 60, diagnosis of non-alcoholic fatty liver disease by fatty infiltration on ultrasound and abnormal serum liver function tests (AST or ALT>30 u/l in men and >20 in women), no smoking, BMI between 25 to 35, no pregnancy or lactation, no use of dietary supplements 2 month prior to enrollment, not having diabetes, , acute heart disease, , other form of liver disease (viral or autoimmune hepatitis, metabolic and hereditary liver disease), no usual use of Olive Oil in dietary pattern, no use of drugs that induces steatosis (amidarone, methotrexate, systemic glucocorticoid, tetracycline, tamoxifen, estrogen, anabolic steroids, valporic acid) , no use of Lipid lowering drugs . Exclusion Criteria: those who are not interested in participating in the study, start using drugs affecting liver functiont, failure to complete or correct use of Olive Oil according to the instruction given , change in recommended diet and daily physical activity 20 years 60 years Both k76.0 Fatty ( change of ) liver , not elsewhere classified Treatment - Other N/A intervention group :Extra Virgin Olive Oil, 20% of total daily energy requirement olive will be replaced with usual daily consumption of oil for every patients for 12 weeks control group :( not application )20% of total daily energy requirement from usual daily consumption of oil for 12 weeks Serum ALT. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: IFCC,IU/D. Sserum AST. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: IFCC,IU/D. Steatosis severity. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Sonography. TNF α. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: ELISA5,Pg/L. Fasting TG. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl. Insulin resistance. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: calculation. Fasting insulin. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Immunoassay radiometer,ΜU / ml. FastingGlucose. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Colorimetric method.mg / dl. HDL - C. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl. LDL - C. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl. Total cholestrol. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: enzymetic method , mg / dl. Percent body weight. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: Caliper, percent. BMI. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: calculation,Kg / m2. Waist circumference. Timepoint: BEFORE AND END OF INTERVENTION. Method of measurement: TAPE , Cm. Vice-chancellor for Research, Tehran University of Medical Sciences Approved 2011-09-23 Faculty of Public Health of Tehran University of Medical Sciences Number 60, Alvand street, Argentina square, Tehran TEHRAN Iran (Islamic Republic of)