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IRCT20171107037302N2 IRCT 2021-11-14 Esfahan University of Medical Sciences curcumin-piperine supplementation in children with none- alcoholic fatty liver disease ندارد The effect of curcumin-piperine supplementation on glycemic indices, lipid profiles, anthropometric indices and liver function in children with none- alcoholic fatty liver disease 2021-11-22 anticipated 60 Complete https://irct.ir/trial/59811 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website: https://www.sealedenvelope.com/simple-randomiser/v1/lists), Blinding description: In this study, children will not be aware of received intervention. furthermore, before the beginng of intervention, curcumin supplements and their placebo which are completely similar to each other, will be coded to A and B by a third person rather than main researcher to keep blindness of study. N/A none- alcoholic fatty liver disease. Intervention 1: Intervention group: Intervention group will receive a capsule containing curcumin-piperine in the amount of 500 mg of curcumin and 5 mg of piperine once a day for 10 weeks. Intervention 2: Control group: The control group will receive capsules containing placebo. Each capsule contains 500 mg of maltodextrin for 10 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information
public Sahar Saraf-Bank
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3172 saraf2shr@yahoo.com Esfahan University of Medical Sciences scientific Sahar Saraf-Bank
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3172 saraf2shr@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) diagnosis of NAFLD (grades 1–3) according to liver ultrasonography children with BMI percentile>=85 for age age 10-18 years old 10 years 18 years Both presence of hepatitis, Chronic liver disease , Cardiovascular, renal, Pulmonary, Hypothyroidism diseases and cancer not consuming drugs that could affect on ALT level including HMG-COA reductase inhibitors, metformin K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Intervention group will receive a capsule containing curcumin-piperine in the amount of 500 mg of curcumin and 5 mg of piperine once a day for 10 weeks. Control group: The control group will receive capsules containing placebo. Each capsule contains 500 mg of maltodextrin for 10 weeks Weight. Timepoint: At the beginning of study - week 10. Method of measurement: Seca scale. Height. Timepoint: At the beginning of study - week 10. Method of measurement: Strip meter. Waist circumference. Timepoint: At the beginning of study - week 10. Method of measurement: strip meter. Hip circumference. Timepoint: At the beginning of study - week 10. Method of measurement: strip meter. Body mass index. Timepoint: At the beginning of study - week 10. Method of measurement: formula. Fasting blood sugar. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. Triglycerides. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. Low-density lipoprotein. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. High-density lipoprotein. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. Total cholesterol. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. Alanine aminotransferase. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. Aspartate aminotransferase. Timepoint: At the beginning of study - week 10. Method of measurement: biochemical assessment. Fasting insulin. Timepoint: At the begining of study - week 10. Method of measurement: biochemical assessment. Esfahan University of Medical Sciences Approved 2021-10-20 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue isfahan Isfehan Iran (Islamic Republic of)