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IRCT20121216011763N42 IRCT 2020-01-10 Esfahan University of Medical Sciences Effect of Curcumin-Piperine in Fatty Liver The effect of Curcumin-Piperine supplementation on cardiometabolic factors, hepatic steatosis and fibrosis of fibroscan results and liver function in patients with non-alcoholic fatty liver disease: a randomized double-blind clinical trial 2019-12-21 anticipated 60 Complete https://irct.ir/trial/43732 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin and placebo groups.The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses, Blinding description: This study is a double blind clinical trial (participant, researcher). The curcumin supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study. N/A Nonalcoholic fatty liver. Intervention 1: Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will recive after meal for 12 weeks. Intervention 2: Control group: A daily placebo capsule(500 mg lactose) will recive after meal for 12 weeks. Yes - There is a plan to make this available What will be shared: The collected deidentified for the primary outcome measure only will be shared. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: askari@mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:

public Gholamreza Askari

Hezarjarib Ave

Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Askari

Hezarjarib Ave

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Tendency to participate in the study People aged 18-65 years Patients with Non-alcoholic fatty liver (grade 3-1) diagnosed by ultrasound 18 years 65 years Both Pregnancy and lactation Patients with Alcoholic Fatty Liver Smoking People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, hypothyroidism and Cushing's syndrome Consumption of lipid and glucose lowering medicine, Vitamin E, Vitamin D, Orsodeoxycholic acid, Phenytoin, Tamoxifen, Lithium, Corticosteroids and Methotrexate Weight loss and bariatric surgery in the last year K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will recive after meal for 12 weeks. Control group: A daily placebo capsule(500 mg lactose) will recive after meal for 12 weeks. TG. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. TC. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. HDL. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. LDL. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Weight. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Digital scale. Waist circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: non-stretching tape measure. BMI. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Dividing the weight into kilograms by squared height by meter. ALT. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic photometric method. AST. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic photometric method. Hepatic steatosis and fibrosis. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Fibroscan. Esfahan University of Medical Sciences Approved 2019-11-05 Ethics committee of Isfahan University of Medical Sciences Hezarjarib Ave., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)