Attention, Healthy
Conditions
Keywords
DHA, fMRI
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTdocosahexaenoic acid
DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
8 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. Male subjects between the ages of 8 - 10 years. 2. Not breast-fed during infancy 3. Right hand dominant 4. Attending school at appropriate grade level 5. Normal body-mass index (BMI) 6. Ability and willingness to provide assent and informed, written consent from at least one biological parent. 7. Present with biological parent 8. No current general medical or psychiatric illness. 9. Medication free. 10. Normal intelligence as assessed by the Kaufman Brief Intelligence Test. 11. Willingness to maintain current dietary habits.
Exclusion criteria
1. Inability or unwillingness to provide consent. 2. Antecedent or concurrent serious medical illness. 3. A lifetime history of any significant axis I psychiatric disorder ( i.e. bipolar disorder, schizophrenia) 4. Patients who have received any psychoactive medications, current and lifetime. 5. Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease. 6. History of seizures, excluding febrile seizures in childhood. 7. Patients requiring treatment with any drug which might obscure the action of study the study treatment. 8. Less than normal intelligence. 9. Pacemaker 10. Cerebral aneurysm clip 11. Cochlear implant 12. Metal fragments lodged within the eye 13. Claustrophobia 14. Necessity of sedation (no sedation will be given). 15. History of loss of consciousness \> 10 minutes in duration 16. Adopted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| performance on sustained attention task (CPT-IP) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP) | 8 weeks |
| NAA concentrations | 8 weeks |
Countries
United States
Outcome results
None listed