This trial is active, not recruiting.

Condition healthy
Treatment no intervention
Sponsor Arkansas Children's Hospital Research Institute
Start date September 2002
End date September 2017
Trial size 600 participants
Trial identifier NCT00616395, 07130


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
IDE used for outcome measurement not for an intervention.
no intervention

Primary Outcomes

Growth and development
time frame: yearly, 1-6 years

Eligibility Criteria

Male or female participants from 1 month up to 3 months old.

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

Additional Information

Official title Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children
Principal investigator Aline Andres, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute.