Skip to main content
OpenTrials
Completed

NCT Number: NCT02199808

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Executive Function

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC-Chapel Hill's Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Sigma Xi

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2014
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.