HealthyNCT03108014
Beginnings Study Follow up
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study will help us learn more about how early infant diet may influence child's growth and development at age 14. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2017to 17 Jul 2024
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Former Beginnings participants between ages 13 and 15 years
Who may be able to join
- Beginnings study former participants
Who cannot join
- Dropped participants for medical diagnosis or medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
This study will help us learn more about how early infant diet may influence child's growth and development at age 14.
Read the detailed description
This study is to follow the infants that were enrolled in Beginnings study which purpose was 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 up to age 6. This study will call back those children when they turn 14 to compare growth, sexual maturation, and development between the three diets.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast milk fed | Fed primarily breast fed as an infant | |
| Cow's Milk based infant formula fed | Fed primarily cow's milk based infant formula for the first year of life | |
| Soy-protein based formula fed | Fed primarily soy-protein based infant formula during the first year of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth and development
Will be determined with body composition equipment
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start17 Sep 2017
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 191 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, PhD, RD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108014
- Sponsor's protocol ID
- 206291
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2017
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leandro da Cruz L, Fiecke C, Reed B, Martinez A, Keck A, Fuenmayor A, Sobik S, Rowell AC, Moore MB, Bimali M, Williams DK, Andres A. Soy Protein-Based Infant Formula Feeding Association with Adolescent Growth, Body Composition, Cardiometabolic Health, and Pubertal Development in Comparison with Cow's Milk-Based Infant Formula and Human Milk Feeding. J Nutr. 2026 Mar;156(3):101376. doi: 10.1016/j.tjnut.2026.101376. Epub 2026 Jan 22.
PubMed 41580087
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
- Beginnings Study Follow up
- ClinicalTrials.gov ID
- NCT03108014
- Acronym / sponsor ID
- 206291
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 17 Sep 2017 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
This study will help us learn more about how early infant diet may influence child's growth and development at age 14.
Detailed description
This study is to follow the infants that were enrolled in Beginnings study which purpose was 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 up to age 6. This study will call back those children when they turn 14 to compare growth, sexual maturation, and development between the three diets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast milk fed | – | –Fed primarily breast fed as an infant |
| Cow's Milk based infant formula fed | – | –Fed primarily cow's milk based infant formula for the first year of life |
| Soy-protein based formula fed | – | –Fed primarily soy-protein based infant formula during the first year of life |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Former Beginnings participants between ages 13 and 15 years
Key inclusion criteria (1 listed)
- Beginnings study former participants
Key exclusion criteria (1 listed)
- Dropped participants for medical diagnosis or medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth and development
Time frame: 14 years
Will be determined with body composition equipment
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 41580087Leandro da Cruz L, Fiecke C, Reed B, Martinez A, Keck A, Fuenmayor A, Sobik S, Rowell AC, Moore MB, Bimali M, Williams DK, Andres A. Soy Protein-Based Infant Formula Feeding Association with Adolescent Growth, Body Composition, Cardiometabolic Health, and Pubertal Development in Comparison with Cow's Milk-Based Infant Formula and Human Milk Feeding. J Nutr. 2026 Mar;156(3):101376. doi: 10.1016/j.tjnut.2026.101376. Epub 2026 Jan 22.
- Individual participant dataSharing planned: No
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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, PhD, RD principal investigator
Arkansas Children's Nutrition Center
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 1 inclusion and 1 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: 14 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 NCT03108014, which also lists 1 linked publication.
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.