Overview

This trial is active, not recruiting.

Condition cognitive development
Sponsor University of North Carolina, Chapel Hill
Start date January 2010
End date November 2011
Trial size 202 participants
Trial identifier NCT01942434, 09-1869

Summary

Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of breastfed infants.

Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast milk sample.

Phase 2: At 6 months of age child participates in electrophysiology session to test recognition memory.

Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical assessments.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Relation between recognition memory and maternal FADS genotype
time frame: 6 months

Secondary Outcomes

Measure
Nutrient content of breastmilk as it relates to FADS genotype
time frame: 3 to 4 months
Nutrient content of breastmilk as it relates to recognition memory
time frame: 6 months
Relation between declarative memory and breastmilk nutrients
time frame: 26 or 38 months
Relation between declarative memory and concurrent nutrients
time frame: 26 or 38 months

Eligibility Criteria

Male or female participants from 3 months up to 4 months old.

Inclusion Criteria: - typically-developing - exclusively breastfed - unremarkable delivery Exclusion Criteria: - non-English speaking - history of seizure activity

Additional Information

Official title The Influence of FADS2 rs 174575 on Breastmilk Fatty Acid Levels and the Recognition Memory Abilities of 6-month Old Breastfed Infants and Follow-up
Principal investigator Carol L Cheatham, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.