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Fatty Acids and Executive Function Development in 7-12 Year Olds

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ClinicalTrials.gov Identifier: NCT02199808
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Sigma Xi
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related changes in executive functions in children and older adults.

Participants: Eighty-four typically-developing 7-to 12-year-old children.

Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three sessions will consist of the screening. These sessions will be telephone calls to collect 24-hour diet information that will be used to determine whether they are eligible for the fourth session. Approximately 120 participants will be screened to find 84 participants who are eligible for the fourth session, in which participants will complete a series of tests on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that provides computerized versions of standardized cognitive tests. They will also complete a maze task in which they figure out a path through the maze by walking on the correct squares. Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.


Condition or disease
Executive Function

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fatty Acids and Executive Functions: Cortical Activation and Behavioral Performance.
Study Start Date : April 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Group/Cohort
7-9 year olds
These are children who are between 7 and 9 years old when they are tested.
10-12 year olds
These are children who are between 10 and 12 years old when they are tested.



Primary Outcome Measures :
  1. Error (count) and latency (in milliseconds) measures from executive function tasks [ Time Frame: One time with children who are 7-12 years old ]

    For one specific aim, the omega-6 to omega-3 fatty acid ratio will be determined by summing the omega-6 and omega-3 fatty acid levels in plasma and dividing omega-6 fatty acids by omega-3 fatty acids. The calculated ratio will be used to predict error and latency scores on executive function tasks.

    For a second specific aim, the oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements will be used to predict the error and latency measures from executive function tasks.



Secondary Outcome Measures :
  1. Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) [ Time Frame: One time with children who are 7-12 years old. ]
    Plasma levels of omega-6 and omega-3 fatty acids will be used to predict oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements in children who are 7-12 years old.

  2. Performance on the Maze as measured by Noldus Ethovision [ Time Frame: One time with children who are 7-12 years old ]
    Performance on the Maze as measured by Noldus Ethovision tracking system will be compared to performance on standardized measures of planning and spatial working memory.



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All participants will be typically-developing, healthy 7-to-12-year-olds who are fluent in English. Every effort will be made to recruit roughly equal numbers of boys and girls. Recruitment will be conducted irrespective of race and ethnicity. An attempt will be made to match the sample to the race and ethnicity of the region: 80% White, 15% African-American, and 5% Native American, Asian, and Other descent.
Criteria

Inclusion Criteria:

  • Typically-developing children 7-12 years old

Exclusion Criteria:

  • Children or parents who do not speak English
  • Any diagnosis of a psychological illness
  • History of seizures
  • History of tobacco exposure during gestation
  • History of alcohol exposure during gestation

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): NCT02199808


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Sigma Xi
Investigators
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Principal Investigator: Kelly W Sheppard, Ph.D. University of North Carolina, Chapel Hill
Study Director: Carol L Cheatham, Ph.D. University of North Carolina, Chapel Hill