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IRCT201311215623N14 IRCT 2013-12-11 Kashan University of Medical Sciences Effect of low caloric diet in fatty liver Effects of the hypocaloric DASH diet (Dietary Approaches to Stop Hypertension) on liver enzymes, lipid profiles and insulin resistance in patients with fatty liver 2014-11-01 anticipated 60 Complete https://irct.ir/trial/6044 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take DASH (n = 30) or control (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants and the assessors of the outcomes are unaware of the study groups. 3 Non Alcoholic Fatty Liver Disease. Intervention 1: Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 8 weeks. Intervention 2: Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 8 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 Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Bolvare Ghotbe Ravandi, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 36 1446 3378 asemi_z@kaums.ac Kashan University of Medical Sciences Iran (Islamic Republic of) Subjects aged 25-75 years All patients with laboratorial and sonographical criteria of fatty liver. 25 years 75 years Both Consumption of alcohol Pregnancy and lactation Hereditary hemochromatosis History of jejunoileal bypass surgery or gastroplasty Taking hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens History of hypothyroidism Cushing’s syndrome Renal failure and kidney stones k76.0 Fatty (change of) liver, not elsewhere classified Other Other Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 8 weeks Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 8 weeks ALT. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic. AST. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic. Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa. Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa. Total Antioxidant Capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Fasting plasma glucose. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic. Triglycerides. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Insulin resistance. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa kit. Grade of fatty liver. Timepoint: Baseline and End-of-trial. Method of measurement: Sonography. Kashan University of Medical Sciences Approved 2013-11-20 Kashan University of Medical Sciences Bolvare Ghotbe Ravandi, Kashan Kashan Isfehan Iran (Islamic Republic of)