Clinical trial NCT01634776: Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans
Official title: Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Fatty Acids on Memory Performance of Toddlers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 66
Sex: ALL
Minimum age (years): 16
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in declarative memory performance
timeFrame: Baseline, 120 days
Secondary outcomes:
measure: Change in fatty acid levels in plasma
timeFrame: Baseline, 120 days
measure: Stability of methylation of promoter region of FADS2 gene
timeFrame: Baseline, 120 days
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC at Chapel Hill Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carol L Cheatham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Mihai D Niculescu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheatham CL, Lupu DS, Niculescu MD. Genetic and epigenetic transgenerational implications related to omega-3 fatty acids. Part II: maternal FADS2 rs174575 genotype and DNA methylation predict toddler cognitive performance. Nutr Res. 2015 Nov;35(11):948-55. doi: 10.1016/j.nutres.2015.09.005. Epub 2015 Sep 11.
citation: Lupu DS, Cheatham CL, Corbin KD, Niculescu MD. Genetic and epigenetic transgenerational implications related to omega-3 fatty acids. Part I: maternal FADS2 genotype and DNA methylation correlate with polyunsaturated fatty acid status in toddlers: an exploratory analysis. Nutr Res. 2015 Nov;35(11):939-47. doi: 10.1016/j.nutres.2015.09.004. Epub 2015 Sep 10.