Cognitive DevelopmentNCT01942434

Fatty Acid Levels and Memory in Breastfed Children

An observational study of Cognitive Development, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 3 to 4 monthsHealthy volunteers can take part
Conditions the study is for: Cognitive Development
How many people: 202 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Aug 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 4 months
All sexes
Healthy volunteers accepted
Child

Study population: Breastfeeding infants and their mothers

Who may be able to join

typically-developing
exclusively breastfed
unremarkable delivery

Who cannot join

non-English speaking
history of seizure activity

Trial locations and contacts

1 site in 1 country.

United States1 site

Nutrition Research Institute
Kannapolis, North Carolina, 28081

Other trials in United States

About this study

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

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.

Conditions: Cognitive Development
Keywords: Fatty acids, Breast milk nutrients, Cognitive development, Electrophysiology, Long-term assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Relation between recognition memory and maternal FADS genotype
At 6 months of age, during the second session (Phase 2)
Measured: 6 months

Secondary outcomes (4)

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)
Measured: 3 to 4 months
Nutrient content of breastmilk as it relates to recognition memory
At 6 months of age, during the second session (Phase 2)
Measured: 6 months
Relation between declarative memory and breastmilk nutrients
At session 3, when the child was either 26 or 38 months of age (Phase 3)
Measured: 26 or 38 months
Relation between declarative memory and concurrent nutrients
At session 3, when the child was either 26 or 38 months of age (Phase 3)
Measured: 26 or 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Aug 2016

First posted16 Sep 2013 (estimated)
Study startJan 2010
Primary completionNov 2011
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cognitive DevelopmentStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01942434
Sponsor's protocol ID: 09-1869
Status last verified: Dec 2020
First submitted: 6 Sep 2013
Last updated: 16 Dec 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Development trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01942434
Acronym / sponsor ID: 09-1869
Conditions: Cognitive Development
Keywords: Fatty acids, Breast milk nutrients, Cognitive development, Electrophysiology, Long-term assessment
Study type: Observational
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: Jan 2010 (actual)
Primary completion: Nov 2011 (actual)
Study completion: Aug 2016 (actual)
First posted: 16 Sep 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 3 to 4 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Breastfeeding infants and their mothers

Key inclusion criteria (3 listed)

typically-developing
exclusively breastfed
unremarkable delivery

Key exclusion criteria (2 listed)

non-English speaking
history of seizure activity

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

Nutrient content of breastmilk as it relates to FADS genotype
Time frame: 3 to 4 months
Nutrient content of breastmilk as it relates to recognition memory
Time frame: 6 months
Relation between declarative memory and breastmilk nutrients
Time frame: 26 or 38 months
Relation between declarative memory and concurrent nutrients
Time frame: 26 or 38 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.

Related trials for Cognitive Development

Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
RecruitingObservational study
Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
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Psilocybin for Treatment-Resistant Depression in Autism
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carol L Cheatham, PhD principal investigator

UNC at Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Development, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relation between recognition memory and maternal FADS genotype (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.