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Completed

NCT Number: NCT03513991

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

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.

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Key information

Conditions

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

Age range

1 day–40 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autonoma de Queretaro

Querétaro City, Querétaro, 76230, Mexico

About this study

Developing an IF with A2 β-casein, high proportion of alpha-lactoalbumin and less protein that commercial IF, similar to breast milk (1g/100 mL), could be and important strategy to decrease the risk of diseases. This infant formula was compared with breast milk and two other IF with different protein composition. The three formulas were packed in the same presentation and identified by a number. Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn. the present study

Infants' mothers were recruited from six health centers from the Health Ministry in Querétaro, México. Directors of each health center authorized the protocol study. The field workers were read and explained the informed consent letter, the objectives, procedures, risks and benefits of the study in detail.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full-term newborn (≥37 weeks of gestation)
  • Birth weight ≥2500 g and ≤4000 g
  • Apgar score > 8
  • Infants from birth to 40 days of age at the time of enrollment
  • Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn.

Exclusion criteria

  • Infants with congenital heart defect, congenital illness or malformations, severe gastrointestinal disease, kidney, liver, central nervous system, or metabolic disease, or born from mothers with gestational diabetes.

Treatment and study plan

Infant Formula

Other

Primary outcomes

  1. Change in weight

    Time frame: Baseline to 4 months of age

    Weight

Secondary outcomes

  1. Anthropometry measurements

    Time frame: Baseline, 1, 2 ,3 and 4 months of age

    Measurements will include length and head circumference, and together with the primary outcome of weight, will be used to calculate z-scores using WHO Growth Standards.

  2. Beta-casomorphin 7 concentration

    Time frame: Baseline and at 4 months of age

    Quantification of beta-casomorphin 7 concentration in urine

  3. Number of gastrointestinal events

    Time frame: Baseline, 1, 2, 3, and 4 months

    Gastrointestinal events will be recorded by the mothers. These events include: constipation, diarrhea, regurgitation, vomit, reflux, colic, constant crying, and stool consistency and color, using previously reported scales (Bekkali et al, 2009; Trabulsi, 2011).

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Queretaro

Other

Collaborators

  • NUCITEC S.A. de C.V.

Registry information

Official study title

Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2018
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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