Clinical trial NCT02199808: Fatty Acids and Executive Function Development in 7-12 Year Olds
Official title: Fatty Acids and Executive Functions: Cortical Activation and Behavioral Performance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Executive Function
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Sigma Xi
First posted: 2014-07-25
Enrollment: 79
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be typically-developing, healthy 7-to-12-year-olds who are fluent in English. Every effort will be made to recruit roughly equal numbers of boys and girls. Recruitment will be conducted irrespective of race and ethnicity. An attempt will be made to match the sample to the race and ethnicity of the region: 80% White, 15% African-American, and 5% Native American, Asian, and Other descent.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Error (count) and latency (in milliseconds) measures from executive function tasks
timeFrame: One time with children who are 7-12 years old
Secondary outcomes:
measure: Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)
timeFrame: One time with children who are 7-12 years old.
measure: Performance on the Maze as measured by Noldus Ethovision
timeFrame: One time with children who are 7-12 years old
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC-Chapel Hill's Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carol L Cheatham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.