NCT03108014

Brief Summary

This study will help us learn more about how early infant diet may influence child's growth and development at age 14.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 17, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6.8 years

First QC Date

April 5, 2017

Last Update Submit

January 16, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Growth and development

    Will be determined with body composition equipment

    14 years

Study Arms (3)

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

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Former Beginnings participants between ages 13 and 15 years

You may qualify if:

  • Beginnings study former participants

You may not qualify if:

  • Dropped participants for medical diagnosis or medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

  • 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.

    PMID: 41580087DERIVED

Study Officials

  • Aline Andres, PhD, RD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

September 17, 2017

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)