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NCT03513991
Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
NA trial testing Infant formula in Growth & Development in 20 participants. Completed in 8 August 2017.
8 August 2017
Quick facts
| Lead sponsor | Universidad Autonoma de Queretaro |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 15 February 2016 |
| Primary completion | 8 August 2017 |
| Estimated completion | 8 August 2017 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Infant formula — full drug profile →
Conditions studied
- Growth & Development — all drugs for Growth & Development →
- Formula Feeding of Healthy Full Term Infants — all drugs for Formula Feeding of Healthy Full Term Infants →
- Breast Feeding of Healthy Full Term Infants — all drugs for Breast Feeding of Healthy Full Term Infants →
Sponsor
Universidad Autonoma de Queretaro
Who can join
Adults 1 Day to 40 Days, any sex, with Growth & Development or Formula Feeding of Healthy Full Term Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin. The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Lower Protein Intake Supports Normal Growth of Full-Term Infants Fed Formula: A Randomized Controlled Trial.
Oropeza-Ceja LG, Rosado JL, Ronquillo D, García OP, et al · · 2018 · cited 17× · PMID 29996492 · DOI 10.3390/nu10070886 -
Higher versus lower protein intake in formula-fed term infants.
Gonzalez-Garay AG, Serralde-Zúñiga AE, Medina Vera I, Velasco Hidalgo L, et al · · 2023 · cited 5× · PMID 37929831 · DOI 10.1002/14651858.cd013758.pub2
Verify or expand the search:
- PubMed search for NCT03513991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Infant formula
Trials testing the same drug.
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- NCT04182425 — Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis · completed
- NCT03476889 — Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants · NA · unknown
- NCT03487094 — Growth and Tolerance of Infants Fed Formula for 16 Weeks · NA · completed
- NCT03320837 — Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics · completed
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03513991 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Autonoma de Queretaro
- Last refreshed: 2 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03513991.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing