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

December 11, 2020 updated by: Carol Cheatham, PhD, University of North Carolina, Chapel Hill

Fatty Acids and Executive Functions: Cortical Activation and Behavioral Performance.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

79

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

    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • UNC-Chapel Hill's Nutrition Research Institute

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

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

One time with children who are 7-12 years old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One time with children who are 7-12 years old.
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.
One time with children who are 7-12 years old

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Carol L Cheatham, Ph.D., University of North Carolina, Chapel Hill

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.

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

April 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 14-0198

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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