Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds

March 29, 2013 updated by: Carol Cheatham, PhD, University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • UNC at Chapel Hill Nutrition Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

7-9 year olds

Description

Inclusion Criteria:

  • typically-developing

Exclusion Criteria:

  • not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between executive function and n-6/n-3 fatty acid intake
Time Frame: up to 10 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperament
Time Frame: Baseline
Temperament will be measured using a Rothbart written assessment completed by the caregiver.
Baseline
Socioeconomic status
Time Frame: Baseline
Demographic information will be collected from caregiver using a lab-typical questionnaire.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Carol L Cheatham, PhD, UNC-Chapel Hill
  • Study Director: Kelly W Sheppard, BS, UNC-Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

March 29, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 10-1401 (University of Colorado Cancer Center - Anschutz Cancer Pavilion)

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.

Clinical Trials on Typical Development

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe