Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans

Not Applicable

Completed

• Conditions: Effect of Fatty Acids on Memory Performance of Toddlers
• Interventions: Dietary Supplement: corn oil; Dietary Supplement: Flaxseed oil

• Registration Number: NCT01634776
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Fatty acids or omega-3s are important in the human diet for brain development. Of the three main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3; docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been shown to be important in brain function. Conversely, little is known about the effects of ALA even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in the human diet, ALA is more readily available, more easily consumed, and less expensive relative to animal sources of DHA and EPA. So, it is very important that the investigators explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA conversion rate can be altered by methylation, an epigenetic form of gene expression and regulation. In the present study, the investigators will examine memory abilities and genetic baselines in 16-month-olds. The investigators will then supplement their food with ALA or control oil for 4 months. At 20 months, the investigators will collect outcome data on memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA conversion through methylation and genetic variations and subsequently, memory abilities will improve. The data from this study will be used to design a larger R01 grant.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 16-month-old toddlers and their natural mothers
• Born fullterm and healthy with no complications
• English as first language

Read More

Exclusion Criteria

• Any toddler with a documented neurological or blood disorder will be excluded.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corn oil	corn oil	1288 mg/day corn oil
Flaxseed oil	Flaxseed oil	1200 mg/day flaxseed oil

Primary Outcome Measures

Name	Time	Method
Change in declarative memory performance	Baseline, 120 days

Secondary Outcome Measures

Name	Time	Method
Change in fatty acid levels in plasma	Baseline, 120 days
Stability of methylation of promoter region of FADS2 gene	Baseline, 120 days

Trial Locations

Locations (1)

UNC at Chapel Hill Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States