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IRCT20100524004010N30 IRCT 2020-06-11 Shahid Beheshti University of Medical Sciences Evaluation of the effects of a low free sugar diet in patients with Nonalcoholic fatty liver disease Evaluation of the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease 2019-07-23 anticipated 42 Complete https://irct.ir/trial/48475 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study، in order to the randomization process، a simple randomization is used by using a table of random numbers. before beginning the study،each person is placed in one of the intervention or control groups based on a simple random division table. we have considered a two-digit code for the number of sample size numbers, and selected the start point by referring to the table, and based on the adjacent two-digit number, moved in the direction of the row, and we choose the first two-digit number less than 50 as the first sample and we'll continue to do this until the samples reach 50. N/A Nonalcoholic fatty liver disease. Intervention 1: Intervention group: a low free sugar diet with dietary and physical activity recommendations/12 weeks. Intervention 2: Control group: Dietary and physical activity recommendations/12 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 We have not yet decided how to share the final data.
public azita hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The desire to participate in research Age 60-18 years BMI above 20 Evidence of non-alcoholic steatohepatitis (inflammation and swelling of hepatocytes) second and third degree in ultrasonography Evidence of non-alcoholic steatohepatitis in fibro-scan results with CAP Score over 263 Lack of a history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men Lack of other chronic and acute liver diseases and disorders (hepatitis B, C, etc.), biliary disease, autoimmune diseases, cancer and hereditary disorders affecting the condition of the liver (iron, copper storage disease) and cirrhosis Lack of pregnancy or lactation in women No consumption of hepatotoxic drugs such as phenytoin, tamoxifen and lithium, and drugs that affect liver function 18 years 60 years Both Lack of desire to continue research Forced to use antibiotics or hepatotoxic drugs during the study Non-compliance with low free sugar diet low free sugar diet, lipid profile, glycemic indices, liver enzymes, inflammatory factors, hepatic steatosis , fibrosis , patients with Nonalcoholic fatty liver disease Lifestyle Lifestyle Intervention group: a low free sugar diet with dietary and physical activity recommendations/12 weeks Control group: Dietary and physical activity recommendations/12 weeks Hepatic steatosis, Liver fibrosis. Timepoint: At the first and at the 12th week of the study. Method of measurement: Fibroscan. Weight. Timepoint: At the first , 6th and 12th week of the study. Method of measurement: Scale. BMI. Timepoint: At the first , 6th and 12th week of the study. Method of measurement: Calculate. Waist to hip ratio. Timepoint: At the first , 6th and 12th week of the study. Method of measurement: Calculate. Liver enzymes (AST,ALT,GGT). Timepoint: At the first and at the 12th week of the study. Method of measurement: Enzymatic method. Lipid profile (TG,Total cholesterol,LDL-C,HDL-C). Timepoint: At the first and at the 12th week of the study. Method of measurement: Enzymatic method. FBS. Timepoint: At the first and at the 12th week of the study. Method of measurement: Enzymatic method. Insulin. Timepoint: At the first and at the 12th week of the study. Method of measurement: Radioimmunoassay. Hs-CRP. Timepoint: At the first and at the 12th week of the study. Method of measurement: ELISA. TNF-α. Timepoint: At the first and at the 12th week of the study. Method of measurement: ELISA. NF-κB. Timepoint: At the first and at the 12th week of the study. Method of measurement: ELISA. HOMA-IR. Timepoint: At the first and at the 12th week of the study. Method of measurement: Calculate. QUICKI. Timepoint: At the first and at the 12th week of the study. Method of measurement: Calculate. Shahid Beheshti University of Medical Sciences Approved 2020-01-05 Ethics Committee of the National Institute of Nutritional Research and Food Industry No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)