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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-01-31

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.

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Detailed Description

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Conditions

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Healthy Attention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio

Group Type EXPERIMENTAL

docosahexaenoic acid

Intervention Type DIETARY_SUPPLEMENT

DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio

Interventions

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docosahexaenoic acid

DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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DHA

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No