NCT01823419

Brief Summary

The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty acids on executive functions. The investigators hypothesize that participants ages 7-9 years with a ratio closer to 4:1 will do better on tests of executive function than participants with a ratio closer to the purported Western diet norm of 15:1.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

March 20, 2013

Last Update Submit

March 29, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relation between executive function and n-6/n-3 fatty acid intake

    Executive function will be measured using a validated and standardized system known as CANTAB (Cambridge Neuropsychological Test Automated Battery) and correlated with the ratio of fatty acid intake. 24-hour diet recalls will be completed using the NDSR (Nutrient Data System for Research) software. Across one week, the children will be interviewed 3 times (two weekdays, one weekend day) about what they ate in the previous 24 hours. The dietary data will be averaged to arrive at the n-6/n-3 intake. The children will then come to lab for one visit where they will be assessed using the CANTAB.

    up to 10 days

Secondary Outcomes (2)

  • Temperament

    Baseline

  • Socioeconomic status

    Baseline

Study Arms (1)

7-9 year olds

Typically developing 7- to 9-year-olds will be enrolled and tested.

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

7-9 year olds

You may qualify if:

  • typically-developing

You may not qualify if:

  • not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC at Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (2)

  • 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. Omega-6 to omega-3 fatty acid ratio and higher-order cognitive functions in 7- to 9-y-olds: a cross-sectional study. Am J Clin Nutr. 2013 Sep;98(3):659-67. doi: 10.3945/ajcn.113.058719. Epub 2013 Jul 3.

Biospecimen

Retention: NONE RETAINED

No biospecimens will be collected.

Study Officials

  • Carol L Cheatham, PhD

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Kelly W Sheppard, BS

    UNC-Chapel Hill

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 20, 2013

First Posted

April 4, 2013

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 4, 2013

Record last verified: 2013-03

Locations