Omega-3, Autism Spectrum Disorder (ASD) (OMeASD)

Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD

This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).

Study Overview

• Status: Recruiting
• Conditions: ASD
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Placebo

Detailed Description

This is a 12 week study to investigate the effects of omega-3 PUFAs in children (6-17 years-old) with ASD.

The primary outcome will be the clinical symptoms rated by the Aberrant Behavior Checklist (ABC). The secondary outcomes will be inflammatory biomarkers, cognitive function and physiological markers such as heart-rate variability (HRV).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Chen Chang, MD, PhD; Phone Number: 4126 0422052121; Email: d13121@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Taichung
    • Taichung, Taichung, Taiwan, 404
      • Recruiting
      • China Medical University
      • Contact: Pei-Chen Chang, MD, PHD; Phone Number: 886 4 22052121; Email: 013121@tool.caaumed.org.tw
      • Principal Investigator: Pei-Chen Chang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosis of DSM5 ASD made by child and adolescent psychiatrist
• age 6-17 years-old at the time of enrolment
• no pharmacotherapy or non-pharmacotherapy adjustment within the past 4 weeks,
• Signed informed consent.

Exclusion Criteria:

• comorbid other psychiatric disorders, including schizophrenia or affective mood disorder (Bipolar and Major Depressive Disorder), or substance use disorder
• comorbid physical disorders, such as thyroid dysfunction, cerebral palsy, coagulation disorders
• currently using omega-3 supplements or probiotics
• allergy to omega-3.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega-3 (EPA); EPA	Dietary supplement: Omega-3; Omega-3 PUFAs
Placebo Comparator: Placebo; Soybean Oil	Dietary supplement: Placebo; Soybean Oil
Experimental: Omega-3 (DHA); DHA	Dietary supplement: Omega-3; Omega-3 PUFAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC)	The ABC will be used to assess the behavioral problems of participants. It consists of 58 items that describe various behaviors, such as aggression or hyperactivity, and is typically completed by a caregiver or teacher who knows the individual well. Each item is rated on a 4-point scale: 0 = not at all a problem, 1 = slight problem, 2 = moderate problem, and 3 = severe problem. Scores are summed across all items to produce a total score ranging from 0 to 174, with higher scores indicating more severe or frequent problem behaviors	Baseline, week 1,2,4,8,12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of blood inflammatory biomarkers in pg/mL	Interleukin (IL)-1 beta (picogram/milliliter, pg/ML) IL-6 IL-10 Tumor necrosis factor -αlpha Interferon (IFN)-γ	Baseline and week 12
Cognitive function-attention and impulsivity (Continuous Performance Test, CPT)	CPT will be used to measure the attention and impulsivity in the subjects.	Baseline and week 12
Clinical symptoms: Behavioral problems (Strength and Difficulty Questionnaire, SDQ)	SDQ will be used to assess behavior problems of the participants. SDQ is a brief behavioral screening tool for children and adolescents, typically aged 3-16, designed to assess emotional and behavioral difficulties as well as prosocial strengths. It has 25 items divided into five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Problems, and Prosocial Behavior, with each subscale containing 5 items. Items are rated on a 3-point scale: 0 = "Not True," 1 = "Somewhat True," 2 = "Certainly True." Scoring involves summing the first four subscales to calculate a Total Difficulties Score (range 0-40), while the Prosocial subscale is scored separately (range 0-10) as a measure of strengths. Higher Total Difficulties Scores indicate greater behavioral or emotional problems, while higher Prosocial scores indicate stronger social skills.	Baseline and week 12
Stool Sample	Gut microbiomal sequencing, Faecal short-chain fatty acids	Baseline and week 12
Heart Rate variability (HRV)	Autonomic nervous function (ANS) will be assessed with HRV.	Baseline and week 12
Concentration of blood high-sensitivity C-reactive Protein (hs-CRP)	measurement of peripheral blood hs-CRP units in milligram/Liter (mg/L)	Baseline and week 12
Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs)	Measurement of RBC PUFAs units in %	Baseline and week 12
Cognitive function: memory (Wechsler Memory Scale, WMS)	WMS will be used to measure memory function of the subjects.	Baseline and week 12
Clinical symptoms: attention and hyperactivity (Swanson, Nolan, and Pelham Rating Scale - Version IV, SNAP-IV)	The SNAP-IV is used to assess attention, hyperactivity and oppositional defiant disorder symptoms in the subjects. It contains 26 items rated on a 4-point scale from 0 ("Not at all") to 3 ("Very much"), reflecting the frequency or severity of each behavior. The items are grouped into three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant behaviors, with scores summed within each subscale. Higher scores indicate more severe symptoms, and the scale can be completed by parents, teachers, or clinicians to provide a reliable measure for both clinical evaluation and research.	Baseline and week 12

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Pei-Chen Chang, MD, PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: adolescent; inflammation; omega-3
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Fatty Acids; Lipids; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Fish Oils; Docosahexaenoic Acids
• Other Study ID Numbers: CMUH110-REC3-113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No