HealthyBeginningsNCT00616395
Study of Early Infant Diet on Growth and Development
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants
Who may be able to join
- Healthy Infants
- Birth weight = 6 to 9 lbs
- Mostly fed breast milk, milk-based formula, soy-based formula
- Mother over 18 years of age
Who cannot join
- Unhealthy pregnancy
- Illness during pregnancy or for the child that could interfere with the study parameters
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children
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
- Being tested
- No intervention
- Keywords
- Infant Nutrition, Soy Phytochemicals, Infant Body Composition, Brain Function, Cognition and Development, Healthy Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDevice
| Study group | Role | What they receive |
|---|---|---|
| no grouping | IDE used for outcome measurement not for an intervention. Receives: Device: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth and development
Measured: yearly, 1-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startSep 2002
- Primary completionSep 2017
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline Andres, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616395
- Sponsor's protocol ID
- 07130
- Acronym
- Beginnings
- Status last verified
- Sep 2026
- First submitted
- 31 Dec 2007
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
da Cruz LL, Fiecke C, Fuenmayor A, Beckett E, Morris A, Kay CD, Massey-Swindle T, Sobik S, Andres A. Effect of antenatal breast milk expression or postnatal dietary intervention on breastfeeding outcomes and human milk composition in women with excess weight: protocol for the Ready, Set, Nourish study, a randomized controlled trial. Front Nutr. 2026 Sep 18;13:1854997. doi: 10.3389/fnut.2026.1854997. eCollection 2026.
PubMed 42827763Chen 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.
PubMed 37028556Sobik 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.
PubMed 32961547Brink 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.
PubMed 32330237Andres 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.
PubMed 25761499Andres 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.
PubMed 23375908
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children
- ClinicalTrials.gov ID
- NCT00616395
- Acronym / sponsor ID
- Beginnings / 07130
- Conditions
- Healthy
- Keywords
- Infant Nutrition, Soy Phytochemicals, Infant Body Composition, Brain Function, Cognition and Development, Healthy Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2002 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no grouping | – | Device: No interventionIDE used for outcome measurement not for an intervention. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants
Key inclusion criteria (4 listed)
- Healthy Infants
- Birth weight = 6 to 9 lbs
- Mostly fed breast milk, milk-based formula, soy-based formula
- Mother over 18 years of age
Key exclusion criteria (2 listed)
- Unhealthy pregnancy
- Illness during pregnancy or for the child that could interfere with the study parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Device | no grouping |
Primary outcome
Growth and development
Time frame: yearly, 1-6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 42827763da Cruz LL, Fiecke C, Fuenmayor A, Beckett E, Morris A, Kay CD, Massey-Swindle T, Sobik S, Andres A. Effect of antenatal breast milk expression or postnatal dietary intervention on breastfeeding outcomes and human milk composition in women with excess weight: protocol for the Ready, Set, Nourish study, a randomized controlled trial. Front Nutr. 2026 Sep 18;13:1854997. doi: 10.3389/fnut.2026.1854997. eCollection 2026.
- Derived from this study: PubMed 37028556Chen 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.
- Derived from this study: PubMed 32961547Sobik 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.
- Derived from this study: PubMed 32330237Brink 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.
- Derived from this study: PubMed 25761499Andres 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.
- Derived from this study: PubMed 23375908Andres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline Andres, Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth and development (time frame: yearly, 1-6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00616395, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.