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

Phase 3

Completed

• Conditions: Healthy; Attention
• Interventions: Dietary Supplement: docosahexaenoic acid

• Registration Number: NCT00662142
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-21
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	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

Primary Outcome Measures

Name	Time	Method
performance on sustained attention task (CPT-IP)	8 weeks

Secondary Outcome Measures

Name	Time	Method
fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP)	8 weeks
NAA concentrations	8 weeks

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States