Study of Early Infant Diet on Growth and Development

NCT ID: NCT00616395

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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no grouping

IDE used for outcome measurement not for an intervention.

No intervention

Intervention Type DEVICE

Interventions

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No intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aline Andres, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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Chen JR, Samuel HA, Shlisky J, Sims CR, Lazarenko OP, Williams DK, Andres A, Badger TM. A longitudinal observational study of skeletal development between ages 3 mo and 6 y in children fed human milk, milk formula, or soy formula. Am J Clin Nutr. 2023 Jun;117(6):1211-1218. doi: 10.1016/j.ajcnut.2023.04.002. Epub 2023 Apr 5.

Reference Type DERIVED
PMID: 37028556 (View on PubMed)

Sobik S, Sims CR, McCorkle G, Bellando J, Sorensen ST, Badger TM, Casey PH, Williams DK, Andres A. Early infant feeding effect on growth and body composition during the first 6 years and neurodevelopment at age 72 months. Pediatr Res. 2021 Jul;90(1):140-147. doi: 10.1038/s41390-020-01157-z. Epub 2020 Sep 22.

Reference Type DERIVED
PMID: 32961547 (View on PubMed)

Brink LR, Mercer KE, Piccolo BD, Chintapalli SV, Elolimy A, Bowlin AK, Matazel KS, Pack L, Adams SH, Shankar K, Badger TM, Andres A, Yeruva L. Neonatal diet alters fecal microbiota and metabolome profiles at different ages in infants fed breast milk or formula. Am J Clin Nutr. 2020 Jun 1;111(6):1190-1202. doi: 10.1093/ajcn/nqaa076.

Reference Type DERIVED
PMID: 32330237 (View on PubMed)

Andres A, Moore MB, Linam LE, Casey PH, Cleves MA, Badger TM. Compared with feeding infants breast milk or cow-milk formula, soy formula feeding does not affect subsequent reproductive organ size at 5 years of age. J Nutr. 2015 May;145(5):871-5. doi: 10.3945/jn.114.206201. Epub 2015 Mar 11.

Reference Type DERIVED
PMID: 25761499 (View on PubMed)

Andres A, Casey PH, Cleves MA, Badger TM. Body fat and bone mineral content of infants fed breast milk, cow's milk formula, or soy formula during the first year of life. J Pediatr. 2013 Jul;163(1):49-54. doi: 10.1016/j.jpeds.2012.12.067. Epub 2013 Feb 1.

Reference Type DERIVED
PMID: 23375908 (View on PubMed)

Other Identifiers

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07130

Identifier Type: -

Identifier Source: org_study_id

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