Study of Early Infant Diet on Growth and Development

NCT00616395 | Completed

• 1 other identifier: 07130
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Growth and development

  yearly, 1-6 years

Study Arms (1)

no grouping

IDE used for outcome measurement not for an intervention.

Device: No intervention

Interventions

No intervention DEVICE

no grouping

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy infants

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (5)

• 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.

  PMID: 37028556 DERIVED

• 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.

  PMID: 32961547 DERIVED

• 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.

  PMID: 32330237 DERIVED

• 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.

  PMID: 25761499 DERIVED

• 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.

  PMID: 23375908 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, urine, and stool may be collected from some study participants.

Study Officials

• Aline Andres, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: February 15, 2008
• Study Start: September 1, 2002
• Primary Completion: September 1, 2017
• Study Completion: June 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)