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Study aim
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Determining the effect of a low-carbohydrate, calorie-restricted diet and a standard calorie-restricted diet on liver enzyme levels, insulin resistance, and body composition (including height, weight, body fat mass, body fat-free mass, and body water) in obese or overweight children and adolescents suffering from non-alcoholic fatty liver disease
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Design
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A double-arm, randomized clinical trial, with sample size of 60 people (30 people in each group)
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Settings and conduct
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Participants are selected from the number of people who refer to Tehran Children's Medical Center Hospital. If they are eligible, they will enter the study. In the case of blinding, the anthropometric evaluations and the measurement of biochemical factors in the blood samples of the participants will be done by persons who are not aware of the group of each participant.
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Participants/Inclusion and exclusion criteria
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Eligible participants in this study are children and adolescents aged 5 to 18 years with NAFLD and obesity or overweight.
⋆ Age 5 to 18 years
⋆ Obesity or overweight
⋆ NAFLD based on serum ALT levels
Non-entry criteria:
⋆ suffering from other liver diseases
⋆ Suffering from autoimmune diseases
⋆ suffering from hereditary metabolic diseases
⋆ History of receiving intravenous nutrition
⋆ History of using steatogenic drugs
⋆ Alcohol consumption
⋆ Pregnancy
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Intervention groups
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Intervention group: the group receiving a low-carbohydrate diet with limited calories
Control group: the group receiving the standard calorie-restricted diet
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Main outcome variables
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Liver enzyme levels (ALT and AST); body composition (including height, weight, body fat mass, body fat-free mass and body water); lipid profile (TG, TC, LDL, HDL); insulin resistance (by HOMA-IR index); Fasting plasma glucose