We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662142
First Posted: April 21, 2008
Last Update Posted: May 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Cincinnati
  Purpose
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.

Condition Intervention Phase
Healthy Attention Dietary Supplement: docosahexaenoic acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • performance on sustained attention task (CPT-IP) [ Time Frame: 8 weeks ]

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

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DHA

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662142


Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Robert McNamara, PhD University of Cincinnati
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00662142     History of Changes
Other Study ID Numbers: 05-12-13-03 (MARTEK)
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by University of Cincinnati:
DHA
fMRI


To Top