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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Effect of Fatty Acids on Memory Performance of Toddlers

Treatments

Dietary Supplement: corn oil
Dietary Supplement: Flaxseed oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01634776
09-0358

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

16 to 16 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

66 participants in 2 patient groups, including a placebo group

Corn oil
Placebo Comparator group
Description:
1288 mg/day corn oil
Treatment:
Dietary Supplement: corn oil
Flaxseed oil
Experimental group
Description:
1200 mg/day flaxseed oil
Treatment:
Dietary Supplement: Flaxseed oil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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