Fatty Acid Levels and Memory in Breastfed Children

December 11, 2020 updated by: Carol Cheatham, PhD, University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • Nutrition Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 4 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breastfeeding infants and their mothers

Description

Inclusion Criteria:

  • typically-developing
  • exclusively breastfed
  • unremarkable delivery

Exclusion Criteria:

  • non-English speaking
  • history of seizure activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between recognition memory and maternal FADS genotype
Time Frame: 6 months
At 6 months of age, during the second session (Phase 2)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrient content of breastmilk as it relates to FADS genotype
Time Frame: 3 to 4 months
Sample provided in session 1 when the infant was 3-4 months old (Phase 1)
3 to 4 months
Nutrient content of breastmilk as it relates to recognition memory
Time Frame: 6 months
At 6 months of age, during the second session (Phase 2)
6 months
Relation between declarative memory and breastmilk nutrients
Time Frame: 26 or 38 months
At session 3, when the child was either 26 or 38 months of age (Phase 3)
26 or 38 months
Relation between declarative memory and concurrent nutrients
Time Frame: 26 or 38 months
At session 3, when the child was either 26 or 38 months of age (Phase 3)
26 or 38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Carol L Cheatham, PhD, UNC at Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09-1869

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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