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IRCT20210119050086N1 IRCT 2021-02-20 Tehran University of Medical Sciences Effect of moderate restriction diet in treatment of non-alcoholic fatty liver disease The effect of moderate carbohyderate restriction diet on liver enzymes, steatosis and fibrosis in normal weight individuals with non-alcoholic fatty liver disease: a parallel randomized controlled clinical trials 2021-11-22 anticipated 52 Complete https://irct.ir/trial/53824 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals will be classified based on age, gender (male/female) and BMI (±2) into different blocks. To do randomization, an identification code will be given to each participant, and then the codes of each two participants with the same age, gender and BMI will be poured into the lottery container. Random allocation will be done by a person who is unaware of the study. The first code will be assigned to the intervention group, the second code to the control group and so other participants will be randomly assigned to the two groups. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Intake of moderate carbohydrate restriction diet, which included 40-45% of energy from carbohydrates, 35-40% of energy from fat, and the rest of energy from a source of protein. Intervention 2: Control group: Intake of isocaloric diet, which included 50-55% of energy from carbohydrates, 25-30% from fat, and the rest of energy from a source of protein. 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 Fatemeh Dashti
No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5975 Fatemehda1996@gmail.com Tehran University of Medical Sciences scientific Fatemeh Dashti
No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5975 Fatemehda1996@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Body mass index 18.5-25 kg/m2 Age range 18-65 years Patients with non-alcoholic fatty liver disease 18 years 65 years Both Alcohol consumption Pregnancy or breastfeeding Suffering from other liver diseases Consuming corticosteroids during the last three months Drugs or tobacco use Follow a weight loss diet during the last three months K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Treatment - Other Intervention group: Intake of moderate carbohydrate restriction diet, which included 40-45% of energy from carbohydrates, 35-40% of energy from fat, and the rest of energy from a source of protein. Control group: Intake of isocaloric diet, which included 50-55% of energy from carbohydrates, 25-30% from fat, and the rest of energy from a source of protein. Steatosis. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Fibro-scan. Liver enzyme (ALT, AST and GGT). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Blood sample. Lipid profile (TG, Total cholesterol, LDL-c and LDH-c). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Blood sample. Glycemic index (FBS, FBI, HOMA-IR and QUICKI). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Blood sample. Weight. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Scales. Waist circumference. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Tape meter. Body mass index (BMI). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Formula (weight (kilograms) divided by the squared height (meters)). Fibrosis. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Fibro-scan. Tehran University of Medical Sciences Approved 2021-01-10 Ethics committee of Tehran University of Medical Sciences Office of the Vice Chancellor for Research, First Floor, Building No. 1, School of Medicine, North Door of the University, Poursina St., Ghods St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)