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Fatty Acid Levels and Memory in Breastfed Children

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ClinicalTrials.gov Identifier: NCT01942434
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease
Cognitive Development

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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding Memory




Primary Outcome Measures :
  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 Outcome Measures :
  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)


Biospecimen Retention:   Samples With DNA
saliva, blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Breastfeeding infants and their mothers
Criteria

Inclusion Criteria:

  • typically-developing
  • exclusively breastfed
  • unremarkable delivery

Exclusion Criteria:

  • non-English speaking
  • history of seizure activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942434


Locations
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United States, North Carolina
Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Carol L Cheatham, PhD UNC at Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01942434    
Other Study ID Numbers: 09-1869
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Keywords provided by University of North Carolina, Chapel Hill:
Fatty acids
Breast milk nutrients
Cognitive development
Electrophysiology
Long-term assessment