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Study of Early Infant Diet on Growth and Development

Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00616395
Acronym
Beginnings
Enrollment
600
Registered
2008-02-15
Start date
2002-09-01
Completion date
2025-06-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Infant Nutrition, Soy Phytochemicals, Infant Body Composition, Brain Function, Cognition and Development, Healthy Infants

Brief summary

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.

Interventions

DEVICENo intervention

Sponsors

Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Growth and developmentyearly, 1-6 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAline Andres, Ph.D.

University of Arkansas

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026