Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-21
Brief Title:
Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 276 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 144 23 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 solveFaced 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 supplyAlthough 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 clearThis 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 excitationinhibition 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
Detailed Description:
1 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 Childrens Sleep Habit Questionnaire CSHQ and Spectral Magnetic ResonanceMRS 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
2 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 In 1921 Wilder an American doctor first put forward the concept of ketogenic diet which was used to treat epilepsy in children and achieved remarkable results After 100 years development ketogenic diet has evolved into a variety of diet schemes among which four are recognized by scholars at home and abroad namely classic ketogenic diet classic KD medium chain triglyceride diet MCT diet improved Atkins diet improved MAD and low glycemic index therapy LGITWe chose the classic ketogenic diet as the treatment planIts keto food fat gnon-keto food protein and carbohydrate g ratio is 4 1 fat accounts for about 90 protein is about 7 and carbohydrates are about 3 limiting calorie intake Professional nutritionists will refer to the height and weight percentile value table of children and adolescents aged 0-18 to evaluate the growth and development of children If the growth and development are within the standard range or low the recommended hot card is the actual weight Recommended per kilogram The intake of hot cards should be high If the growth and development are higher than the standard range the recommended hot cards should be the standard weight corresponding to the actual height Recommend the intake of hot cards per kilogram and combine the amount of exercise of the child and whether to take hormone drugs etc An individualized diet plan for its growth and development after determining the hot card the nutritionist will carry out individualized meals according to the childs food allergies and other conditions
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 Childrens Sleep Habit Questionnaire CSHQ and Spectral Magnetic ResonanceMRS 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
2 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 In 1921 Wilder an American doctor first put forward the concept of ketogenic diet which was used to treat epilepsy in children and achieved remarkable results After 100 years development ketogenic diet has evolved into a variety of diet schemes among which four are recognized by scholars at home and abroad namely classic ketogenic diet classic KD medium chain triglyceride diet MCT diet improved Atkins diet improved MAD and low glycemic index therapy LGITWe chose the classic ketogenic diet as the treatment planIts keto food fat gnon-keto food protein and carbohydrate g ratio is 4 1 fat accounts for about 90 protein is about 7 and carbohydrates are about 3 limiting calorie intake Professional nutritionists will refer to the height and weight percentile value table of children and adolescents aged 0-18 to evaluate the growth and development of children If the growth and development are within the standard range or low the recommended hot card is the actual weight Recommended per kilogram The intake of hot cards should be high If the growth and development are higher than the standard range the recommended hot cards should be the standard weight corresponding to the actual height Recommend the intake of hot cards per kilogram and combine the amount of exercise of the child and whether to take hormone drugs etc An individualized diet plan for its growth and development after determining the hot card the nutritionist will carry out individualized meals according to the childs food allergies and other conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None