NCT01942434

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

September 6, 2013

Last Update Submit

December 11, 2020

Conditions

Cognitive Development

Keywords

Fatty acidsBreast milk nutrientsCognitive developmentElectrophysiologyLong-term assessment

Outcome Measures

Primary Outcomes (1)

  • Relation between recognition memory and maternal FADS genotype

    At 6 months of age, during the second session (Phase 2)

    6 months

Secondary Outcomes (4)

  • Nutrient content of breastmilk as it relates to FADS genotype

    3 to 4 months

  • Nutrient content of breastmilk as it relates to recognition memory

    6 months

  • Relation between declarative memory and breastmilk nutrients

    26 or 38 months

  • Relation between declarative memory and concurrent nutrients

    26 or 38 months

Eligibility Criteria

Age3 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Breastfeeding infants and their mothers

You may qualify if:

  • typically-developing
  • exclusively breastfed
  • unremarkable delivery

You may not qualify if:

  • non-English speaking
  • history of seizure activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva, blood

Study Officials

  • Carol L Cheatham, PhD

    UNC at Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 16, 2013

Study Start

January 1, 2010

Primary Completion

November 1, 2011

Study Completion

August 1, 2016

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

US(1)