Growth & Development Clinical Trial
Official title:
Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration 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.
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.
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