Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function

Study Overview
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Brief Summary
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The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty acid docosahexaenoic acid (DHA) improves attention performance and associated cortical activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.

Official Title
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Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function

Conditions
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Healthy, Attention

Intervention / Treatment
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* Dietary Supplement: docosahexaenoic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects between the ages of 8 - 10 years. Not breast-fed during infancy Right hand dominant Attending school at appropriate grade level Normal body-mass index (BMI) Ability and willingness to provide assent and informed, written consent from at least one biological parent. Present with biological parent No current general medical or psychiatric illness. Medication free. Normal intelligence as assessed by the Kaufman Brief Intelligence Test. Willingness to maintain current dietary habits. Exclusion Criteria: Inability or unwillingness to provide consent. Antecedent or concurrent serious medical illness. A lifetime history of any significant axis I psychiatric disorder ( i.e. bipolar disorder, schizophrenia) Patients who have received any psychoactive medications, current and lifetime. Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease. History of seizures, excluding febrile seizures in childhood. Patients requiring treatment with any drug which might obscure the action of study the study treatment. Less than normal intelligence. Pacemaker Cerebral aneurysm clip Cochlear implant Metal fragments lodged within the eye Claustrophobia Necessity of sedation (no sedation will be given). History of loss of consciousness > 10 minutes in duration Adopted

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio | Dietary Supplement: docosahexaenoic acid<br>* DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio<br>* Other names: DHA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance on sustained attention task (CPT-IP) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP) |  | 8 weeks | 
| NAA concentrations |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, fMRI