]>
IRCT20100524004010N24 IRCT 2018-05-14 Shahid Beheshti University of Medical Sciences The effect of curcumin supplementation on Nonalcoholic Fatty Liver Disease The effect of curcumin supplementation on lipid profile, liver enzymes, inflammatory factors and hepatic steatosis in patients with Nonalcoholic Fatty Liver Disease 2017-04-09 anticipated 50 Complete https://irct.ir/trial/4198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to receive curcumin or placebo, Blinding description: The method use in this study to create a randomization process is simple randomization, so we utilize random number table. Beginning of the study, in order to observe the lack of a comprehension of researcher in each group, the canisters containing the capsules are coded by a person other than the researcher to A and B. N/A Nonalcoholic Fatty Liver Disease. Intervention 1: Intervention group: 1.5 gram curcumin per day for 3 months. Intervention 2: Control group: 1.5 gram maltodextrin per day for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because the participant’s informations should remain confidental.
public Azita Hekmatdoost
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2237 6480 A_hekmat2000@yahoo.com Nutrition Faculty Of Shahid Beheshti University Of Medical Science scientific Azita Hekmatdoost
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2237 6480 A_hekmat2000@yahoo.com Nutrition Faculty Of Shahid Beheshti University Of Medical Science Iran (Islamic Republic of) Age >18 years old Controlled Attenuation Parameter (CAP score)>263 Having a history of alcohol consumption less than 10 mg per day in women and less than 20 mg per day in men Absence of other acute and chronic diseases and disorders of the liver (hepatitis B, C, etc.), biliary disease, known autoimmune diseases, cancer and inherited disorders affecting liver condition (storage disease of iron, and copper. ..) Absence of Hypertension, cardio - vascular diseases, lung disease and kidney disease, cirrhosis and celiac disease Absence of pregnancy or lactation Athletes or hospitalization Not consume medications such as metformin, vitamin E and Ursodeoxycholic Acid (UDCA) Not consume hepatotoxic drugs such as phenytoin, tamoxifen and lithium and corticosteroids and methotrexate Not consume medications of antibiotics over a week during the study period or before entering it No history of weight loss surgery in the past year the 3-month weight loss program No history of hypothyroidism, Cushing's syndrome and diabetes Lack of gall bladder disease 18 years no limit Both (K75.8) Other specified inflammatory liver diseases Treatment - Other Treatment - Other Intervention group: 1.5 gram curcumin per day for 3 months Control group: 1.5 gram maltodextrin per day for 3 months Type of supplement. Timepoint: Begining and end of the study. Method of measurement: Data collection forms. LDL-C. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. HDL-C. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. TG. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. Total Cholestrol. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. AST. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. ALT. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. TNF-α. Timepoint: Begining and end of the study. Method of measurement: ELISA. Hs-CRP. Timepoint: Begining and end of the study. Method of measurement: ELISA. Cytokeratin-18. Timepoint: Begining and end of the study. Method of measurement: ELISA. IL-6. Timepoint: Begining and end of the study. Method of measurement: ELISA. Hepatic Steatosis. Timepoint: Begining and end of the study. Method of measurement: Ultrasound. FBS. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. Serum Insulin. Timepoint: Begining and end of the study. Method of measurement: Radioimmunoassay. HOMA-IR. Timepoint: Begining and end of the study. Method of measurement: Calculation. Ferritin. Timepoint: Begining and end of the study. Method of measurement: ELISA. Uric Acid. Timepoint: Begining and end of the study. Method of measurement: ELISA. Age. Timepoint: Begining of the study. Method of measurement: Question. Sex. Timepoint: begining of the study. Method of measurement: observation. Smoking. Timepoint: Begining of the study. Method of measurement: Questionare. Height. Timepoint: Begining of the study. Method of measurement: Meter. Weight. Timepoint: Begining and end of the study. Method of measurement: Balance. BMI. Timepoint: Begining and end of the study. Method of measurement: Calculation. Total Calorie Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Carbohydrate Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Protein Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Fat Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Fiber Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total MUFA Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total PUFA Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total SFA Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Shahid Beheshti University of Medical Sciences Approved 2017-03-06 Ethics Committee Of Shahid Beheshti University Of Medical Sciences Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)