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

Executive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199808
• Other study ID #: 14-0198
• Status: Completed
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Executive Function

Locations

Country	Name	City	State
United States	UNC-Chapel Hill's Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Sigma Xi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Error (count) and latency (in milliseconds) measures from executive function tasks	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	Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)	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.
Secondary	Performance on the Maze as measured by Noldus Ethovision	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