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

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.

Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial

“…The current results for growth outcomes, including the primary outcome of daily weight gain, are in agreement with findings from previous studies. First and foremost, similar results were found in the study by Karaglani et al, which assessed the effects on growth parameters of a pHF compared to an IPF in 163 healthy formula-fed infants over a period of three months (19). Similarly, other previous studies investigating the effects of different pHFs on growth indices of infants as compared to intact protein-based formulas or breast milk have found no differences among the study groups (20)(21)(22)(23).…”

Safety and Suitability of Infant Formula Manufactured from Extensively Hydrolyzed Whey Protein Compared to Intact Protein: A Combined Analysis of Two Randomized Controlled Studies

“…(2011) [ 10 ], infants fed an HP formula had significantly lower weight-for-length z-scores compared to IP formula-fed infants across ages 2.5 to 7.5 months. As discussed by others [ 9 ], this difference may be due to the lower food consumption observed in this study in the HP formula group. HP formulae contain peptides that can display a bitter taste [ 24 ] and might also lead to more rapid satiation [ 25 , 26 ].…”

“…The findings of this study are consistent with observations reported in other publications. Karaglani et al (2020) [ 9 ], Picaud et al (2020) [ 4 ], and Otten et al (2023) [ 21 ] demonstrated in three randomized controlled studies comparable growth between infants fed a partially or extensively hydrolyzed whey-based formula and infants fed an intact cow’s milk protein formula during the first 4 to 5 months of life. Similar results with no difference in growth characteristics between HP and IP formulae were observed by Wu et al (2017) [ 22 ] in healthy term infants from enrolment to 7 and 13 weeks of life.…”

“…Other studies did also not see a consistent difference in infant formula intake between HP and IP formulae. Karaglani et al (2020) [ 9 ] observed higher weekly infant formula consumption (~+10.5%) in IP compared to HP formulae-fed infants but this difference disappeared when daily infant formula intake was corrected for body weight. Czerkies et al (2018) [ 23 ] reported a more pronounced increase in infant formula intake over time in the HP than in the IP formula group, a difference that, however, was only evident among girls.…”

“…Several studies evaluating HP formulae with standard or low protein content and using extensively or partially hydrolyzed whey or casein proteins indicate that HP formulae are safe in terms of growth when compared to human milk, intact cow’s milk protein formulae, or growth standards [ 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ].…”