NCT01634776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

July 2, 2012

Last Update Submit

March 4, 2013

Conditions

Effect of Fatty Acids on Memory Performance of Toddlers

Outcome Measures

Primary Outcomes (1)

  • Change in declarative memory performance

    Baseline, 120 days

Secondary Outcomes (2)

  • Change in fatty acid levels in plasma

    Baseline, 120 days

  • Stability of methylation of promoter region of FADS2 gene

    Baseline, 120 days

Study Arms (2)

Corn oil

PLACEBO COMPARATOR

1288 mg/day corn oil

Dietary Supplement: corn oil

Flaxseed oil

EXPERIMENTAL

1200 mg/day flaxseed oil

Dietary Supplement: Flaxseed oil

Interventions

Flaxseed oilDIETARY_SUPPLEMENT

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.

Flaxseed oil
corn oilDIETARY_SUPPLEMENT
Corn oil

Eligibility Criteria

Age16 Months - 16 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC at Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (2)

  • 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.

    PMID: 26455892DERIVED

  • 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.

    PMID: 26439440DERIVED

MeSH Terms

Interventions

Linseed OilCorn Oil

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesDietary Fats, UnsaturatedDietary FatsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(1)