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IRCT20140208016529N6 IRCT 2020-12-12 Esfahan University of Medical Sciences Effect of sesame oil in treatment of non-alcoholic fatty liver Evaluation of the effect of sesame oil consumption on liver functionality, metabolic syndrome characteristics, insulin resistance, oxidative stress, inflammation and ultrasound findings in women with non-alcoholic fatty liver 2020-12-21 anticipated 56 Complete https://irct.ir/trial/52288 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A stratified randomized permuted block( with block size 4) will be generated by an independent bio-statistician. Random assignment will be done by the use of a table of random numbers. The participant's enrollment and assignment to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the end of the statistical analysis (allocation concealment), Blinding description: The blinding of the oils is done by a third party who is not aware of the objectives of the study. The oils are poured into opaque bottles with the same labels. Patients and researchers will not be aware of of which oils are inside the bottles until the end of the trial. 3 Non-alcoholic fatty liver. Intervention 1: Intervention group: The intervention group includes 28 patients. They are randomly placed in this group. They receive 30 grams of sesame oil daily for 12 weeks. The weight loss diet is written for each person, so that 500 calories are deducted from the calculated energy. Calibrated scales are given to them for accurate oil consumption. At the beginning and end of the study, the desired outcomes will be measured. Intervention 2: Control group: The control group includes 28 patients. They are randomly placed in this group. They receive 30 grams of sunflower oil daily for 12 weeks. The weight loss diet is written for each person, so that 500 calories are deducted from the calculated energy. Calibrated scales are given to them for accurate oil consumption. At the beginning and end of the study, the desired outcomes will be measured. Yes - There is a plan to make this available What will be shared: Major part of information will be available for population. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: entezari@hlth.mui.ac.ir How to obtain: The data will be sent as soon as possible, after receiving the request Comments:
public Masoumeh Atefi
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 3616911151 +9832929575 atefimasoumeh@gmail.com Esfahan University of Medical Sciences scientific Dr. Mohammad Hassan Entezari
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Female Being 20 to 50 years old Having Non-alcoholic fatty liver disease Routine consumption of sunflower oil Body mass index between 25 and 40 20 years 50 years Female Participate in other studies in the last 6 months Having weight loss plans in the last three months Having a special diet in the last three months Smoking Being menopausal Having a history of breast cancer Insulin consumption Having allergies Having other liver diseases except non-alcoholic fatty liver Having hereditary hemochromatosis Having serious diseases such as cancer, cholangitis sclerosis, kidney failure, autoimmunity, malignancies, celiac disease Consumption of mineral multivitamin and omega-3 supplements in the past month Consumption of drugs that effects on the level of liver enzymes of ALP, AST and ALT Consumption of drugs that cause fatty liver Using hepatotoxicity drugs Alcohol consumption Pregnancy Lactation Having hormone-dependent cysts Having Wilson's disease K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Treatment - Other Intervention group: The intervention group includes 28 patients. They are randomly placed in this group. They receive 30 grams of sesame oil daily for 12 weeks. The weight loss diet is written for each person, so that 500 calories are deducted from the calculated energy. Calibrated scales are given to them for accurate oil consumption. At the beginning and end of the study, the desired outcomes will be measured. Control group: The control group includes 28 patients. They are randomly placed in this group. They receive 30 grams of sunflower oil daily for 12 weeks. The weight loss diet is written for each person, so that 500 calories are deducted from the calculated energy. Calibrated scales are given to them for accurate oil consumption. At the beginning and end of the study, the desired outcomes will be measured. Fatty liver grade. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Liver sonography. Blood level of low-density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of triglyceride. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of high-density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of total cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Anthropometric indicators. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood pressure. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of insulin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of C-Reactive Protein. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of Malondialdehyde. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of Fasting Blood Sugar. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of Alanine Aminotransferase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of Aspartate transaminase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Blood level of Alkaline phosphatase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Medical laboratory (kit). Esfahan University of Medical Sciences Approved 2020-11-09 Ethics committee of Esfahan University of Medical Sciences Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)