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IRCT20121216011763N47 IRCT 2020-05-14 Esfahan University of Medical Sciences Effect of Curcumin-Piperine in moderate-to-high hepatic steatosis The effects of curcumin plus piperine supplementation on cardiometabolic risk factors and fibroscan findings in patients with moderate-to-high hepatic steatosis : a randomized double blind placebo-controlled trial 2020-09-22 anticipated 60 Complete https://irct.ir/trial/47332 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and body mass index 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 (identical from color, odor and shape) 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 Non-alcoholic fatty liver disease (NAFLD). Intervention 1: Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will receive after meal for 12 weeks. Intervention 2: Control group: A daily placebo capsule(500 mg maltodextrin) will receive 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 be sent to the person within two weeks after receiving the request and reviewing the request. Comments:
public Gholamreza askari
Hezar jarib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Shima Sharifi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 shimasharifi718@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participation in the study Age 18-65 years Evidence indicating non alcoholic fatty liver disease (NAFLD) white grade 2 and 3 diagnosed with sonography. 18 years 65 years Both Alcohol use People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, diabetes, hypothyroidism and Cushing's syndrome Consumption of Metformin, Vitamin E, Orsodeoxycholic acid, Phenytoin, tamoxifen, Lithium, Corticosteroids and Methotrexate within three months of the study. Weight loss or bariatric surgery in recent years Pregnancy Supplement intolerance and unexpected adverse effects R94.5 Abnormal results of liver function studies Treatment - Other Placebo Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will receive after meal for 12 weeks. Control group: A daily placebo capsule(500 mg maltodextrin) will receive after meal for 12 weeks. Triglyceride (TG). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Total Cholesterol (TC). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Low density lipoprotein (LDL). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. High density lipoprotein (HDL). 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 (WC). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Non-stretching tape measure. Body mass index (BMI). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Dividing the weight into kilograms by squared height by meter. Aspartate aminotransferase (AST). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic photometric method. Alanine aminotransferase (ALT). 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. Fasting blood sugar (FBS). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic. Blood pressure. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Sphygmomonometer. Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Esfahan University of Medical Sciences Approved 2019-12-07 National Institute for Medical Research Development (NIMAD) Besat street Tehran Tehran Iran (Islamic Republic of)