Fatty Acids and Executive Function Development in 7-12 Year Olds
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02199808|
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : April 25, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||79 participants|
|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|
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.
- 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.
- 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.
- 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.
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
|United States, North Carolina|
|University of North Carolina at Chapel Hill Nutrition Research Institute|
|Kannapolis, North Carolina, United States, 28081|
|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|