Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06348433 |
| Other study ID # |
QL000003 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Qilu Hospital of Shandong University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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), 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.
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 (LGIT).We chose the classic ketogenic diet as the treatment
plan.Its keto food (fat) g/non-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 child's food allergies and other
conditions.
