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Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.

NCT03513991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-05-02

No results posted yet for this study

Summary

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.

Conditions

  • Growth & Development
  • Formula Feeding of Healthy Full Term Infants
  • Breast Feeding of Healthy Full Term Infants

Interventions

OTHER

Infant formula

Sponsors & Collaborators

  • NUCITEC S.A. de C.V.

    collaborator UNKNOWN

  • Universidad Autonoma de Queretaro

    lead OTHER

Principal Investigators

  • Olga P Garcia, PhD · Universidad Autonoma de Queretaro

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
40 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-15
Primary Completion
2017-08-08
Completion
2017-08-08

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03513991 on ClinicalTrials.gov