Fatty Acid Levels and Memory in Breastfed Children

Cognitive Development Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942434
• Other study ID #: 09-1869
• Status: Completed
• Start date: January 2010
• Est. completion date: August 2016

Study information

• Verified date: December 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2016
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 4 Months

Eligibility

Inclusion Criteria:

• typically-developing
• exclusively breastfed
• unremarkable delivery

Exclusion Criteria:

• non-English speaking
• history of seizure activity

Related Conditions & MeSH terms

• Cognitive Development

Locations

Country	Name	City	State
United States	Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

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