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Our aim was to assess the nutritional safety and suitability of an infant formula manufactured from extensively hydrolyzed protein in comparison to infant formula manufactured from intact protein (both with low and standard protein content). We performed a combined analysis of raw data from two randomized infant feeding studies. An analysis of covariance (ANCOVA) model was used to determine the non-inferiority of daily weight gain (primary outcome; margin −3 g/day), with the intervention group as a fixed factor and geographic region, sex, and baseline weight as covariates (main model). The data of 346 infants exposed to the formula were included in the analysis. The sample size of the per-protocol analysis with 184 infants was too small to achieve sufficient statistical power. The lower limit of the 97.5% confidence interval (−0.807) of the mean group difference in daily weight gain (i.e., 2.22 g/day) was above the −3 g/day margin (full analysis set). Further anthropometric parameters did not differ between the infant formula groups throughout the study. Growth was comparable to breastfed infants. We conclude that the infant formula manufactured from extensively hydrolyzed protein meets infant requirements for adequate growth and does not raise any safety concerns. [ABSTRACT FROM AUTHOR]

Whey protein hydrolysates are recognized for their substantial functional and biological properties. Their high digestibility and amino acid composition make them a valuable ingredient to hydrolyzed whey infant formulas, enhancing both product functionality and nutritional values for infant growth. It is important to understand the functional and biological properties of whey protein hydrolysates for their applications in infant formula systems. This review explored preparation methods of whey protein hydrolysates for infant formula-based applications. The effects of whey protein hydrolysate on the physicochemical and biological properties of hydrolyzed whey infant formulas were summarized. The influences of whey protein hydrolysates on the functional and nutritional properties of formulas from manufacturing to infant consumption were discussed. Whey protein hydrolysates are crucial components in the preparation of infant formula, tailored to meet the functional and nutritional demands of the product. The selection of enzyme types and hydrolysis parameters is decisive for obtaining "optimal" whey protein hydrolysates that match the intended characteristics. "Optimal" whey protein hydrolysates offer diverse functionalities, including solubility, emulsification and production stability to hydrolyzed whey infant formulas during manufacturing processes and formulations. They simultaneously promote protein digestibility, infant growth and other potential health benefits, including reduced allergenic potential, as supported by in vitro, in vivo and clinical trials. Overall, the precise selection of enzymes and hydrolysis parameters in the production of whey protein hydrolysates is crucial in achieving the desired characteristics and functional benefits for hydrolyzed whey infant formulas, making them critical in the development of infant nutrition products., (© 2024 The Authors. Comprehensive Reviews in Food Science and Food Safety published by Wiley Periodicals LLC on behalf of Institute of Food Technologists.)