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

• Main Authors: Eva Karaglani, Inge Thijs-Verhoeven, Marjan Gros, Christina Chairistanidou, Giorgos Zervas, Christina Filoilia, Tarek-Michail Kampani, Vasileios Miligkos, Maria Matiatou, Stavroula Valaveri, Alexandros Sakellariou, Georgios Babilis, Rolf Bos, Yannis Manios
• Format: Article
• Language: English
• Published: MDPI AG 2020-10-01
• Series: Nutrients
• Subjects: infant formula; protein hydrolysate; growth; partially hydrolyzed formula; anthropometry
• Online Access: https://www.mdpi.com/2072-6643/12/10/3056

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 <i>n </i>= 72, control <i>n </i>= 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.