Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children - Trial NCT06348433

Timeline & Enrollment

Primary Outcome

Autism Behavior Checklist（ABC）,Childhood Autism Rating Scale(CARS)

Summary

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.

ICD-10 Classifications