Clinical trial NCT00662142: Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function
Official title: Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Attention
Keywords: DHA
fMRI
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 30
Sex: MALE
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: performance on sustained attention task (CPT-IP)
timeFrame: 8 weeks
Secondary outcomes:
measure: fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP)
timeFrame: 8 weeks
measure: NAA concentrations
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert McNamara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNamara RK, Able J, Jandacek R, Rider T, Tso P, Eliassen JC, Alfieri D, Weber W, Jarvis K, DelBello MP, Strakowski SM, Adler CM. Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Am J Clin Nutr. 2010 Apr;91(4):1060-7. doi: 10.3945/ajcn.2009.28549. Epub 2010 Feb 3.