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

Study Overview
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Brief Summary
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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.

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

Conditions
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Effect of Fatty Acids on Memory Performance of Toddlers

Intervention / Treatment
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* Dietary Supplement: Flaxseed oil
* Dietary Supplement: corn oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Months
Maximum Age: 16 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Corn oil<br>1288 mg/day corn oil | Dietary Supplement: corn oil<br> <br> |
| Experimental: Flaxseed oil<br>1200 mg/day flaxseed oil | Dietary Supplement: Flaxseed oil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in declarative memory performance |  | Baseline, 120 days | 

Secondary Outcome Measures

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