Infant Diet Effects on Brain Function and Language Processing (fMRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Arkansas Children's Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00735423
First received: August 14, 2008
Last updated: May 27, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.

Condition Intervention
Healthy
Device: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Brain function test [ Time Frame: 8 year old ] [ Designated as safety issue: No ]
  • Language processing tests [ Time Frame: 8 year old ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No groups
IDE used for outcome measurement not intervention
Device: No intervention
IDE used for outcome measurement not intervention

  Eligibility

Ages Eligible for Study:   90 Months to 101 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy 8-year-old children
Criteria

Inclusion Criteria:

  • Healthy 8-year-old children
  • Full term
  • Birth weight between the 5th - 95th weight-for-age
  • Use of Breast milk, milk-based formula or soy-based formula throughout first year of life
  • English as primary language
  • Right handed first visit
  • BMI between 5th - 95th percentile-for-age

Exclusion Criteria:

  • Children with sleep disorders
  • Children who use certain medications that may interfere with study assessments
  • Illnesses or diseases or conditions that may interfere with study assessments
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735423

Contacts
Contact: Jill Harsch, BS 501-364-3309 acncstudies@uams.edu

Locations
United States, Arkansas
Arkansas Children's Nutrition Center Recruiting
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Xiawei Ou, Ph.D. Arkansas Children's Nutrition Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00735423     History of Changes
Other Study ID Numbers: 77556 
Study First Received: August 14, 2008
Last Updated: May 27, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Arkansas Children's Hospital Research Institute:
Healthy children
Brain Function
Diet
Nutrition
Language
fMRI
ERP
Behavior

ClinicalTrials.gov processed this record on July 21, 2016