Status:
COMPLETED
Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function
Lead Sponsor:
University of Cincinnati
Conditions:
Healthy
Attention
Eligibility:
MALE
8-10 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00662142
Start Date
January 1 2006
End Date
January 1 2008
Last Update
May 17 2013
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267