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

March 4, 2013 updated by: Carol Cheatham, PhD, University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

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

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Corn oil
1288 mg/day corn oil
Dietary supplement: corn oil
Experimental: Flaxseed oil
1200 mg/day flaxseed oil
Dietary supplement: Flaxseed oil
Families will be asked to mix the contents of one capsule (1200 mg flaxseed oil or 1288 mg corn oil) into a cup of participants' food, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in declarative memory performance
Time Frame: Baseline, 120 days
Baseline, 120 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in fatty acid levels in plasma
Time Frame: Baseline, 120 days
Baseline, 120 days
Stability of methylation of promoter region of FADS2 gene
Time Frame: Baseline, 120 days
Baseline, 120 days

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, Ph.D., University of North Carolina, Chapel Hill
  • Principal Investigator: Mihai D Niculescu, M.D., Ph.D., University of North Carolina, 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

February 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 09-0358

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.

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