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A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial

Eva Karaglani1, Inge Thijs-Verhoeven2, Marjan Gros2

  • 1Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.

Nutrients
|October 10, 2020
PubMed

Insights

Partially hydrolyzed whey infant formula (PHF) supports adequate growth in healthy infants, showing similar results to standard intact protein formula (IPF). This study confirms PHF is a suitable alternative for infant nutrition and development.

Area of Science:

  • Pediatrics
  • Nutrition Science
  • Infant Health

Background:

  • Standard infant formula uses intact protein (IPF), which can sometimes cause digestive issues.
  • Partially hydrolyzed whey infant formula (PHF) is designed for easier digestion.
  • Investigating the growth impact of PHF versus IPF is crucial for infant nutrition.

Purpose of the Study:

  • To compare the growth effects of partially hydrolyzed whey infant formula (PHF) against standard intact protein formula (IPF) in healthy term infants.
  • To determine if PHF supports adequate growth comparable to IPF.
  • To assess anthropometric outcomes in infants fed PHF versus IPF.

Main Methods:

  • A double-blind, non-inferiority, randomized controlled trial was conducted.
  • 163 healthy formula-fed infants (55-80 days old) were randomized to PHF or IPF groups.
  • Infants were followed for three months with monthly evaluations of growth and development.

Main Results:

  • Daily weight gain was similar between PHF and IPF groups, with the lower bound of the 95% CI above the non-inferiority margin (-3 g/day).
  • No significant differences were observed in secondary anthropometric indices (weight, length, head circumference, BMI, Z-scores) between the groups at any time point.
  • The mean difference in daily weight gain was -0.474 g/day (95% CI: -2.460, 1.512).

Conclusions:

  • Partially hydrolyzed whey infant formula (PHF) supports adequate growth in healthy term infants.
  • PHF demonstrates comparable growth outcomes to standard intact protein infant formula (IPF).
  • These findings support the use of PHF as a suitable alternative for infant feeding.

Keywords:
anthropometrygrowthinfant formulapartially hydrolyzed formulaprotein hydrolysate

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