- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199808
Fatty Acids and Executive Function Development in 7-12 Year Olds
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Kannapolis, North Carolina, United States, 28081
- UNC-Chapel Hill's Nutrition Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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7-9 year olds
These are children who are between 7 and 9 years old when they are tested.
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10-12 year olds
These are children who are between 10 and 12 years old when they are tested.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Error (count) and latency (in milliseconds) measures from executive function tasks
Time Frame: One time with children who are 7-12 years old
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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
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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.
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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.
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One time with children who are 7-12 years old.
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Performance on the Maze as measured by Noldus Ethovision
Time Frame: One time with children who are 7-12 years old
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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.
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One time with children who are 7-12 years old
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carol L Cheatham, Ph.D., University of North Carolina, Chapel Hill
Publications and helpful links
General Publications
- Ingol TT, Li R, Boone KM, Rausch J, Klebanoff MA, Turner AN, Yeates KO, Nelin MA, Sheppard KW, Keim SA. Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity. J Nutr. 2019 Dec 1;149(12):2182-2190. doi: 10.1093/jn/nxz115.
- Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
- Sheppard KW, Cheatham CL. Executive functions and the omega-6-to-omega-3 fatty acid ratio: a cross-sectional study. Am J Clin Nutr. 2017 Jan;105(1):32-41. doi: 10.3945/ajcn.116.141390. Epub 2016 Nov 16.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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