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IRCT20131012014988N9 IRCT 2024-01-05 Tabriz University of Medical Sciences The effect of ketogenic diet on autism The effect of ketogenic diet on function autistic children 2023-12-22 anticipated 30 Complete https://irct.ir/trial/73106 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Autism Spectrum Disorder. In this study, children with autism will be treated with a ketogenic diet. The classic ketogenic diet is high in fat, low in carbohydrates, and moderate in protein, adjusted to a ratio of 4:1 or 3:1 (protein and carbohydrate:fat). This diet mimics the state of fasting and changes the metabolism to use fats as the main source of energy, and the catabolism of fatty acids in the liver produces ketone bodies, which causes urinary ketosis. Before starting the regimen, routine tests will be performed and serum beta-hydroxybutyrate levels will be assessed. Also, ATEC questionnaire will be filled for patients. Then the ketogenic diet will be applied to the patients. After four months, the tests will be repeated and the ATEC questionnaire will be filled.. 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 Maintain confidentiality of information
public Dr. Mohammad Barzegar
Maryam St. Golbad St. Tabriz
Tabriz Iran (Islamic Republic of) 5143377505 +98 41 3159 2105 mm_barzegar@yahoo.com Tabriz University of Medical Sciences scientific Dr. Mohammad Barzegar
Maryam St. Golbad St. Abresan. Tabriz
Tabriz Iran (Islamic Republic of) 5143377505 +98 914 117 0492 mm_barzegar@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 3 to 10 years The complaint of speech delay and lack of social communication according to the points obtained: 20-8 with high risk of autism, 3-7 with moderate risk for autism in the completed Modified Checklist for Autism in Toddlers (M-CHAT) questionnaire. The child's parents or caregivers have the appropriate training to start, continue the diet, measure urine ketones, and record information in the relevant form, and the informed consent of the patient's parents for the child's participation in the study; is. 3 years 10 years Both History of clinical seizures in history Presence of epileptiform waves in EEG F84.0 Autistic disorder Treatment - Other In this study, children with autism will be treated with a ketogenic diet. The classic ketogenic diet is high in fat, low in carbohydrates, and moderate in protein, adjusted to a ratio of 4:1 or 3:1 (protein and carbohydrate:fat). This diet mimics the state of fasting and changes the metabolism to use fats as the main source of energy, and the catabolism of fatty acids in the liver produces ketone bodies, which causes urinary ketosis. Before starting the regimen, routine tests will be performed and serum beta-hydroxybutyrate levels will be assessed. Also, ATEC questionnaire will be filled for patients. Then the ketogenic diet will be applied to the patients. After four months, the tests will be repeated and the ATEC questionnaire will be filled. Evaluation of cognitive function. Timepoint: Before starting the diet and 3 months later. Method of measurement: Evaluation and comparison of Autism Treatment Evaluation Checklist (ATEC) score in children with autism before and after the diet. Evaluation and comparison of beta-hydroxybutyrate levels. Timepoint: Before starting the diet and 3 months later. Method of measurement: Serum levels of beta-hydroxybutyrate before and after applying the ketogenic diet will be assessed by a biochemistry autoanalyzer and a commercial kit using a photometric method. Tabriz University of Medical Sciences Approved 2023-12-04 Ethics Committee of Tabriz University of Medical Sciences Golgasht Ave, Medicine faculty Tabriz East Azarbaijan Iran (Islamic Republic of)