Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Early Infant Diet on Growth and Development (Beginnings)

This study is ongoing, but not recruiting participants.
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute Identifier:
First received: December 31, 2007
Last updated: January 13, 2015
Last verified: January 2015

The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.

Condition Intervention
Device: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Growth and development [ Time Frame: yearly, 1-6 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and urine may be collected from some study participants.

Estimated Enrollment: 600
Study Start Date: September 2002
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
no grouping
IDE used for outcome measurement not for an intervention.
Device: No intervention


Ages Eligible for Study:   1 Month to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy infants


Inclusion Criteria:

  • Healthy Infants
  • Birth weight = 6 to 9 lbs
  • Mostly fed breast milk, milk-based formula, soy-based formula
  • Mother over 18 years of age

Exclusion Criteria:

  • Unhealthy pregnancy
  • Illness during pregnancy or for the child that could interfere with the study parameters
  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 identifier: NCT00616395

United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Principal Investigator: Aline Andres, Ph.D. University of Arkansas
  More Information

No publications provided by Arkansas Children's Hospital Research Institute

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arkansas Children's Hospital Research Institute Identifier: NCT00616395     History of Changes
Other Study ID Numbers: 07130
Study First Received: December 31, 2007
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Arkansas Children's Hospital Research Institute:
Infant Nutrition
Soy Phytochemicals
Infant Body Composition
Brain Function
Cognition and Development
Healthy Infants processed this record on February 26, 2015