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

Typical Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823419
• Other study ID #: 10-1401
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: March 29, 2013
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

• typically-developing

Exclusion Criteria:

• not fluent in English

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Typical Development

Locations

Country	Name	City	State
United States	UNC at Chapel Hill Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Temperament	Temperament will be measured using a Rothbart written assessment completed by the caregiver.	Baseline	No
Secondary	Socioeconomic status	Demographic information will be collected from caregiver using a lab-typical questionnaire.	Baseline	No