Abstract
BackgroundA central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk. Milk fat globule membranes (MFGM) have shown to have functional components that are found in human milk, suggesting that addition of bovine sources of MFGM (bMFGM) to infant formula may promote beneficial outcomes potentially helping to narrow the gap between infants who receive human breast milk or infant formula. The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and brain development when compared to infants fed with a standard formula and a reference group of infants fed with mother’s own milk.MethodsSingle center, double-blind, and parallel randomized controlled trial. Planned participant enrollment includes: infants exclusively receiving breast milk (n = 200; human milk reference group; HM) and infants whose mothers chose to initiate exclusive infant formula feeding before 4 months of age (n = 340). The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow’s milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF). Primary outcomes will be: 1) Physical growth (Body weight, length, and head circumference) at 730 days of age; and 2) Cognitive development (Auditory Event-Related Potential) at 730 days of age. Data will be analyzed for all participants allocated to each study feeding group.DiscussionThe results of this study will complement the knowledge regarding addition of bMFGM in infant formula including support of healthy growth and improvement of neurodevelopmental outcomes.Trial registrationNCT02626143, registered on December 10th 2015.
Highlights
A central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk
Even though exclusive breastfeeding until 6 months of age is the recommendation by the World Health Organization to achieve optimal growth and cognitive development [5, 62] only a 40% of infants in the world are currently following such recommendation [63]
There is a need in pediatric nutrition to develop infant formula that could supply similar functional nutrients as the ones found in mother’s own breast milk in order to narrow the gap in neurodevelopmental outcomes
Summary
A central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk. The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and brain development when compared to infants fed with a standard formula and a reference group of infants fed with mother’s own milk. In addition to supporting healthy growth and development [4, 5], breastfed vs non-breastfed infants have lower risks of childhood obesity, type 2 diabetes, and a protective effect against elevated systolic blood pressure, and a higher performance on cognitive development measures [6]. A central aim of pediatric nutritional research, which in turn has guided the development of infant formula to bring it compositionally closer to human milk, is to better meet the needs of formula-fed infants
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