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This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 (EPA) | Experimental | EPA |
|
| Placebo | Placebo Comparator | Soybean Oil |
|
| Omega-3 (DHA) | Experimental | DHA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | Omega-3 PUFAs |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pei-Chen Chang, MD, PhD | Contact | 0422052121 | 4126 | d13121@mail.cmuh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Chen Chang, MD, PhD | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Recruiting | Taichung | Taichung | 404 | Taiwan |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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To investigate the effects of DHA, EPA and placebo in adolescents with ASD
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double blind
| Placebo |
| Dietary Supplement |
Soybean Oil |
|
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 |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |