An interventional study of Ketogenic diet in Autism Spectrum Disorder, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Months to 10 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, which is characterized by social interaction and communication defects, rigid repetitive behaviors, and often accompanied by speech development retardation. According to the report released by the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC), according to the statistical data analysis in 2020, one out of every 36 8-year-old children (2.76%) was confirmed to have autism spectrum disorder (ASD). This ratio is higher than that published in December 2021, when the prevalence rate of 8-year-old children was 1/44 (2.3%) according to the statistics in 2018. Although ASD has a high incidence, there is still a lack of effective treatment measures for autism at present. Drug treatment can only partially alleviate some related symptoms, such as irritability and aggressiveness. Other interventions mainly focus on behavioral and educational interventions, which have limited help to patients. The high cost also leads to a huge burden on families and health care systems. Therefore, finding targeted treatment measures and treatment mechanisms for ASD as soon as possible has become an urgent problem for us to solve.Faced with limited treatment options, as many as a third of parents try various dietary pattern interventions to help their autistic children. In recent years, ketogenic diet, as a diet mode with extremely low carbohydrate, high fat, proper amount of protein and other nutrients, has attracted wide attention. In this mode, increased lipolysis puts the body in a ketosis state, thus ensuring energy supply.Although ketogenic diet (KD) has been proved to be effective in reducing the core symptoms in autistic patients and mouse models, the specific mechanism of KD in autism spectrum disorder (ASD) is still not completely clear.This study aims to evaluate the efficacy of ketogenic diet in improving core symptoms, sleep disorders and gastrointestinal symptoms of ASD children, explore the changes of excitation/inhibition (dorsolateral prefrontal cortex) in prefrontal cortex of ASD children before and after ketogenic diet intervention, and try to reveal the mechanism of ketogenic diet in treating ASD.
Experimental design
First of all, ASD children who come from the outpatient department of pediatric care, Qilu Hospital, Shandong University and have the willingness to join the group are evaluated, and the three routine auxiliary examinations are improved, such as liver and kidney function, blood lipid, myocardial enzyme, hematuria screening for genetic metabolic diseases, EEG and other ketogenic diet-related examinations. ASD children who meet the entry conditions sign informed consent and complete Gastrointestinal Symptom Rating Scale (GSRS score), Children's Sleep Habit Questionnaire (CSHQ) and Spectral Magnetic Resonance(MRS). Children in ketogenic diet group are randomly divided into ketogenic diet group or ordinary diet group by doctors Children in the ordinary diet group can still eat according to the previous diet structure and mode, and are followed up by doctors throughout the whole process.
During this period, children in ketogenic diet group should regularly check blood glucose and ketone values, and measure their height and weight. The outpatient follow-up time is the 30th and 90th days of participating in this project.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Qilu Hospital of Shandong University is the lead sponsor of 305 studies on the registry; 184 are open to participants now.
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Exclusion Criteria:
The subjects were treated with ketogenic diet. Ketogenic diet is a formula diet with high fat, low carbohydrate, proper amount of protein and other nutrients.ASD behavioral intervention measures are designed to help ASD patients improve their social communication skills, communication skills, behavior and other difficulties. Common intervention methods of ASD behavior include cognitive behavioral therapy, social skills training and so on.
Other: Ketogenic diet
ASD behavioral intervention measures are designed to help ASD patients improve their social communication skills, communication skills, behavior and other difficulties. Common intervention methods of ASD behavior include cognitive behavioral therapy, social skills training and so on.
Ketogenic diet is a formula diet with high fat, low carbohydrate, proper amount of protein and other nutrients.
Autism Behavior Checklist（ABC）
There are 57 items in Autism Behavior Checklist（ABC）, including 5 dimensions: sensation, communication, physical movement, language and self-care. The highest score of the whole scale is 158 points, and the lowest score is 0 points. The higher the total score of the scale, the more serious the autistic behavioral symptoms are.
Time frame: At the beginning of ketogenesis and three months after ketogenesis
Childhood Autism Rating Scale(CARS)
The highest score on the Childhood Autism Rating Scale(CARS) scale is 60 points， and the lowest score is 0 points. The higher the total score of the scale, the more serious the autistic behavioral symptoms are.
Time frame: At the beginning of ketogenesis and three months after ketogenesis
Gastrointestinal Symptom Scale（GSRS)
The total score of the Gastrointestinal Symptom Scale（GSRS) ranged from 0 to 78 points, and the higher the score, the more severe the gastrointestinal symptoms of the patient.
Time frame: At the beginning of ketogenesis and three months after ketogenesis
Children's Sleep Habits Questionnaire（CSHQ)
The Children's Sleep Habits Questionnaire（CSHQ) is used to assess Children's sleep behaviors and problems, with a minimum score of 22 and a maximum score of 110. The higher the score, the worse the child's sleep quality.
Time frame: At the beginning of ketogenesis and three months after ketogenesis
MRS
Magnetic resonance spectroscopy (MRS)
Time frame: At the beginning of ketogenesis and three months after ketogenesis,
Plan to share: No
This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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