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IRCT20191009045043N1 IRCT 2020-01-20 Shiraz University of Medical Sciences Investigation The effect of the Sumac powder consumption on patients with non-alcoholic fatty liver Investigation the effect of the Sumac powder on Liver Enzymes, lipid profile, glycemic indexes, Antioxidant marker, inflammatory marker, anthropometric measurements in non-alcoholic fatty liver patients with overweight or obes 2020-01-21 anticipated 46 Complete https://irct.ir/trial/43090 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on block randomization and 4 blocks, the entry of patients into the two study groups will be randomized by using the website www.randomization.com, Blinding description: The blinding method will be that the complement packages of sumac and placebo will receive the labels A and B, only the assistant professor will know the status of placebo and supplements and the supplement provider and the patient will not know about it. 2-3 Nonalcoholic Fatty Liver Disease. Intervention 1: Intervention group: Sumac powder capsule + diet. Intervention 2: Control group: Medicinal starch capsule + diet. 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 There is no more information
public Mohsen Mohit
Razi Blvd, Nutrition School of Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 mohsen.mohit20@yahoo.com Shiraz University of Medical Sciences scientific Najmeh Hejazi
Razi Blvd, Nutrition School of Shiraz University of Medical Scienses
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 nhejazi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Desire to participate in study Male or female 20-60 years old Patient who diagnosed NAFLD with using ultrasound by physician The power of decision making and the ability to do life without the help of others BMI : 25- 35 20 years 60 years Both No history of alcohol using No history of liver cirrhosis Lack of other chronic and acute liver disorders (hepatitis B, C, etc.) and effective hereditary diseases, cancers and hereditary infections affecting the liver (iron storage disease, copper, etc.) Lack of using of blood lipids, blood sugar, vitamin E and UDCA and hepatotoxic drugs such as phenytoin, amoxifen and lithium Lack of celiac disease, diabetes, cardiovascular disease, pulmonary and kidney disease, no history of thyroid problems No history of weight loss surgery, no recent weight loss plan in 3 months Lack of supplementation of fiber, omega-3 and antioxidants in 3 months ago K77 Liver disorders in diseases classified elsewhere Treatment - Drugs Placebo Intervention group: Sumac powder capsule + diet Control group: Medicinal starch capsule + diet Alanine aminotransferase (ALT) enzyme. Timepoint: Baseline and the end of the intervention. Method of measurement: ALT kit. Aspartate aminotransferase (AST) enzyme. Timepoint: Baseline and the end of the intervention. Method of measurement: AST kit. Weight. Timepoint: Baseline and the end of the intervention. Method of measurement: scale/ kg. Cholestrol. Timepoint: Baseline and the end of the intervention. Method of measurement: Cholestrol Kit. Triglyceride. Timepoint: Baseline and the end of the intervention. Method of measurement: Triglyceride Kit. Low-density lipoprotein. Timepoint: Baseline and the end of the intervention. Method of measurement: Low-density lipoprotein Kit. High-density lipoprotein. Timepoint: Baseline and the end of the intervention. Method of measurement: High-density lipoprotein Kit. Fasting blood suger. Timepoint: Baseline and the end of the intervention. Method of measurement: Fasting blood suger Kit. Insulin. Timepoint: Baseline and the end of the intervention. Method of measurement: Insulin Kit. Total Antioxidant Capacity. Timepoint: Baseline and the end of the intervention. Method of measurement: Total Antioxidant Capacity Kit. Tumor Necrosis Factor alpha. Timepoint: Baseline and the end of the intervention. Method of measurement: Tumor Necrosis Factor alpha Kit. Alkaline Phosphatase. Timepoint: Baseline and the end of the intervention. Method of measurement: Alkaline Phosphatase kit. Height. Timepoint: Baseline and the end of the intervention. Method of measurement: Meter. Waist circumference. Timepoint: Baseline and the end of the intervention. Method of measurement: Meter. Hip circumference. Timepoint: Baseline and the end of the intervention. Method of measurement: Meter. Fat mass. Timepoint: Baseline and the end of the intervention. Method of measurement: BIA device. Fat Free mass. Timepoint: Baseline and the end of the intervention. Method of measurement: BIA device. Total Body Water. Timepoint: Baseline and the end of the intervention. Method of measurement: BIA device. Body cell mass. Timepoint: Baseline and the end of the intervention. Method of measurement: BIA device. Gama glutamil transferase enzyme. Timepoint: Baseline and the end of the intervention. Method of measurement: gama glutamil transferase KIt. Shiraz University of Medical Sciences Approved 2019-10-09 Ethics committee of Shiraz University of Medical Sciences Shiraz, zand Ave, Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)