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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662142
• Other study ID #: 05-12-13-03 (MARTEK)
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2008
• Last updated: May 15, 2013
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: May 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention
• Healthy

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance on sustained attention task (CPT-IP)		8 weeks	No
Secondary	fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP)		8 weeks	No
Secondary	NAA concentrations		8 weeks	No