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

NCT02199808 | Completed

• 1 other identifier: 14-0198
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)

  One time with 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Typically-developing children 7-12 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Sigma Xi: collaborator

Study Sites (1)

UNC-Chapel Hill's Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (3)

• 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.

  PMID: 31187863 DERIVED

• 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.

  PMID: 29523147 DERIVED

• 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.

  PMID: 27852615 DERIVED

Study Officials

• Carol L Cheatham, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology & Neuroscience

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (1)