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

May 15, 2013 updated by: University of Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio
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
Other Names:
  • DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
performance on sustained attention task (CPT-IP)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP)
Time Frame: 8 weeks
8 weeks
NAA concentrations
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05-12-13-03 (MARTEK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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