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IRCT20151128025267N8 IRCT 2025-02-16 Tehran University of Medical Sciences Comparison of two different types of diet on the levels of factors related to non-alcoholic fatty liver disease in children and adolescents Comparison of the effect of a low-carbohydrate diet with restricted calories and a standard diet with restricted calories on the levels of liver enzymes, insulin resistance and body composition in obese or overweight children and adolescents with non-alcoholic fatty liver disease. 2024-11-21 anticipated 60 Complete https://irct.ir/trial/79253 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomly divided into two groups: a standard calorie-restricted diet and a calorie-restricted low-carbohydrate diet. A block randomization scheme is used for randomization. The randomization process as mentioned above was done online and by the sealedenvelope website at the address (https://www.sealedenvelope.com/simple-randomiser/v1/lists) and then the output of its production sequence was received in the form of an Excel file. The closed envelope method will be used to perform randomization; For this purpose, 60 envelopes are numbered from 1 to 60 and then according to the random sequence, they are written on papers and sealed inside the envelope according to the received regime. The participants were given an envelope by the relevant nutritionist in the order that they enter the study, and based on the diet in the envelope, they are divided into one of two study groups, i.e., a low-carb diet with limited calories or a standard diet with limited calories, Blinding description: Anthropometric evaluations as well as measurement of biochemical factors in the participants' blood samples will be performed by persons who are not aware of each participant's group, and so-called blinding is done in the case of biochemical evaluations and anthropometry. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group: receiving a low-carbohydrate diet with restricted calories for 12 weeks (percentage distribution of macronutrients for carbohydrates, protein and fat is equal to 50, 25 and 25%, respectively). Intervention 2: Control group: receiving a standard diet with restricted calories for 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 There is no further information
public Maryam Mahmoudi
Keshavarz Blvd., Naderi St., Hojat Dost Alley, No. 44
Tehran Iran (Islamic Republic of) 1417613151 0218895574 maryam.mahmoudi73@gmail.com Tehran University of Medical Sciences scientific Amirhossein Modiri
Keshavarz Blvd., Naderi St., Hojat Dost Alley, No. 44
Tehran Iran (Islamic Republic of) 1417613151 0218895574 sleptoneiros@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 5 to 18 years Obesity or overweight NAFLD based on serum ALT levels 5 years 18 years Both Suffering from other liver diseases Suffering from autoimmune diseases Suffering from hereditary metabolic diseases History of receiving parental nutrition History of taking steatogenic drugs alcohol consumption pregnancy K76.0 Fatty (change of) liver, not elsewhere classified Lifestyle Lifestyle Intervention group: receiving a low-carbohydrate diet with restricted calories for 12 weeks (percentage distribution of macronutrients for carbohydrates, protein and fat is equal to 50, 25 and 25%, respectively) Control group: receiving a standard diet with restricted calories for 12 weeks Alanine amino teransferase. Timepoint: One week before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Blood test and measurement of its values ​​in serum. Aspartate amino teransferase. Timepoint: One week before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Blood test and measurement of its values ​​in serum. Insulin resistance by HOMA-IR index. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: First, measuring fasting glucose and insulin in the serum and then calculating by the formula (Insulin (mU/L) × Glucose (mg/dL)) / 405. Serum insulin. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method. Serum glucose. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: The glucose oxidase-peroxidase coupled method (GOD-POD). Serum triglyceride. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method. Total serum cholesterol. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method. Serum high-density lipoprotein (LDL). Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method. Serum low-density lipoprotein (LDL). Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method. Body weight. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Body analyzer. Height. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: height gauge. Body mass index (BMI) Z-score. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: weight divided by height squared Z-score. The percentage and amount of body fat mass. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Body analyzer. The percentage and amount of body fat-free mass. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Body analyzer. The percentage and amount of body water. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Body analyzer. Tehran University of Medical Sciences Approved 2024-05-14 hildren’s Medical Center-Tehran University of Medical Sciences Secretariat of Ethics Committee in Biomedical Research, University of Tehran, Keshavarz Blvd., Intersection of Quds St., Central Building of Tehran University of Medical Sciences, 6th Floor, Room 604 Tehran Tehran Iran (Islamic Republic of)