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

NCT06348433 | Active Not Recruiting

• 1 other identifier: QL000003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Autism Spectrum Disorder

Keywords

Ketogenic diet

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the beginning of ketogenesis and three months after ketogenesis

Secondary Outcomes (2)

• Gastrointestinal Symptom Scale（GSRS)

  At the beginning of ketogenesis and three months after ketogenesis

• Children's Sleep Habits Questionnaire（CSHQ)

  At the beginning of ketogenesis and three months after ketogenesis

Other Outcomes (1)

• MRS

  At the beginning of ketogenesis and three months after ketogenesis,

Study Arms (2)

Ketogenic diet group

EXPERIMENTAL

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

Ordinary diet group

NO INTERVENTION

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.

Interventions

Ketogenic diet OTHER

Ketogenic diet is a formula diet with high fat, low carbohydrate, proper amount of protein and other nutrients.

Ketogenic diet group

Eligibility Criteria

• Age: 18 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• It meets the diagnostic criteria of ASD in the fifth edition of American Diagnostic Statistical Manual of Mental Disorders;
• Sign informed consent/agree to use ketogenic diet.

You may not qualify if:

• There are diseases related to fatty acid metabolism disorder and abnormal biological oxidation;
• Children who fail to maintain proper nutrition or fail to cooperate;;
• There are obvious intracranial lesions, organic brain diseases, abnormal liver function, abnormal kidney function and cardiovascular diseases;
• There are metal implants or metal foreign bodies in the body.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Yu Wang

Jinan, Shandong, 274400, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: March 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)