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

Completed

• Conditions: Executive Function

• Registration Number: NCT02199808
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Error (count) and latency (in milliseconds) measures from executive function tasks	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

Name	Time	Method
Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)	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.
Performance on the Maze as measured by Noldus Ethovision	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.

Trial Locations

Locations (1)

UNC-Chapel Hill's Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States