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OpenTrials
Completed

NCT Number: NCT01942434

Fatty Acid Levels and Memory in Breastfed Children

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.

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Key information

Conditions

Cognitive Development

Age range

3 month–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • typically-developing
  • exclusively breastfed
  • unremarkable delivery

Exclusion criteria

  • non-English speaking
  • history of seizure activity

Treatment and study plan

Primary outcomes

  1. Relation between recognition memory and maternal FADS genotype

    Time frame: 6 months

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2016
First posted
Sep 16, 2013
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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