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Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds

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ClinicalTrials.gov Identifier: NCT01823419
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Carol Cheatham, PhD, University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty acids on executive functions. The investigators hypothesize that participants ages 7-9 years with a ratio closer to 4:1 will do better on tests of executive function than participants with a ratio closer to the purported Western diet norm of 15:1.

Condition or disease
Typical Development

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Group/Cohort
7-9 year olds
Typically developing 7- to 9-year-olds will be enrolled and tested.



Primary Outcome Measures :
  1. Relation between executive function and n-6/n-3 fatty acid intake [ Time Frame: up to 10 days ]
    Executive function will be measured using a validated and standardized system known as CANTAB (Cambridge Neuropsychological Test Automated Battery) and correlated with the ratio of fatty acid intake. 24-hour diet recalls will be completed using the NDSR (Nutrient Data System for Research) software. Across one week, the children will be interviewed 3 times (two weekdays, one weekend day) about what they ate in the previous 24 hours. The dietary data will be averaged to arrive at the n-6/n-3 intake. The children will then come to lab for one visit where they will be assessed using the CANTAB.


Secondary Outcome Measures :
  1. Temperament [ Time Frame: Baseline ]
    Temperament will be measured using a Rothbart written assessment completed by the caregiver.

  2. Socioeconomic status [ Time Frame: Baseline ]
    Demographic information will be collected from caregiver using a lab-typical questionnaire.


Biospecimen Retention:   None Retained
No biospecimens will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
7-9 year olds
Criteria

Inclusion Criteria:

  • typically-developing

Exclusion Criteria:

  • not fluent in English

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): NCT01823419


Locations
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United States, North Carolina
UNC at Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Carol L Cheatham, PhD UNC-Chapel Hill
Study Director: Kelly W Sheppard, BS UNC-Chapel Hill