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Randomized Controlled Trial
. 2020 Oct 6;12(10):3056.
doi: 10.3390/nu12103056.

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

Eva Karaglani  1 , Inge Thijs-Verhoeven  2 , Marjan Gros  2 , Christina Chairistanidou  1 , Giorgos Zervas  3 , Christina Filoilia  1 , Tarek-Michail Kampani  1 , Vasileios Miligkos  3 , Maria Matiatou  3 , Stavroula Valaveri  3 , Alexandros Sakellariou  1 , Georgios Babilis  3 , Rolf Bos  2 , Yannis Manios  1
Affiliations
Randomized Controlled Trial

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

Eva Karaglani et al. Nutrients. .

Abstract

The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55-80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants' weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.

Keywords: anthropometry; growth; infant formula; partially hydrolyzed formula; protein hydrolysate.

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Conflict of interest statement

I.T.-V., M.G., and R.B. are employees at FrieslandCampina and have been involved in the design of the study, the interpretation of the data, and the writing of the manuscript. Any opinions, findings, conclusions, or recommendations expressed in the current study are those of the authors and do not necessarily reflect the views of FrieslandCampina. The other authors report no conflicts of interest. The present study was funded by FrieslandCampina Nederland B.V. FrieslandCampina had no role in the recruitment of participants, in the collection, management, or analysis of data.

Figures

Figure 1
Figure 1
Study flowchart and subjects’ disposition. Test formula: Partially hydrolyzed whey infant formula; control formula: Standard intact protein formula.
See this image and copyright information in PMC

References

    1. Innis S.M. Impact of maternal diet on human milk composition and neurological development of infants. Am. J. Clin. Nutr. 2014;99:734S–741S. doi: 10.3945/ajcn.113.072595. - DOI - PubMed
    1. Victora C.G., Bahl R., Barros A.J.D., França G.V.A., Horton S., Krasevec J., Murch S., Sankar M.J., Walker N., Rollins N.C., et al. Breastfeeding in the 21st century: Epidemiology, mechanisms, and lifelong effect. Lancet. 2016;387:475–490. doi: 10.1016/S0140-6736(15)01024-7. - DOI - PubMed
    1. Eidelman A.I., Schanler R.J. Breastfeeding and the use of human milk. Pediatrics. 2012;129:e827–e841. doi: 10.1542/peds.2011-3552. - DOI - PubMed
    1. Chomtho S., Wells J.C.K., Williams J.E., Davies P.S.W., Lucas A., Fewtrell M.S. Infant growth and later body composition: Evidence from the 4-component model. Am. J. Clin. Nutr. 2008;87:1776–1784. doi: 10.1093/ajcn/87.6.1776. - DOI - PubMed
    1. Baird J., Fisher D., Lucas P., Kleijnen J., Roberts H., Law C. Being big or growing fast: Systematic review of size and growth in infancy and later obesity. Br. Med. J. 2005;331:929. doi: 10.1136/bmj.38586.411273.E0. - DOI - PMC - PubMed

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