Abstract
BackgroundTo ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow’s milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone.MethodsIn this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow’s milk-based infant formula (Control; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN) (n = 142) or one of two investigational formulas from 14 to 120 days of age. Investigational formulas were supplemented with 4 g/L (1:1 ratio) of a prebiotic blend of PDX and GOS (PDX/GOS; n = 139) or 4 g/L of GOS alone (GOS; n = 138). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120 days of age. Medically-confirmed adverse events were recorded throughout the study.ResultsThere were no group differences in growth rate from 14 to 120 days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher (i.e. softer stools) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group (all P < 0.05). The overall incidence of medically-confirmed adverse events was similar among groups.ConclusionsInvestigational routine infant formulas supplemented with 4 g/L of either a prebiotic blend of PDX and GOS or GOS alone were well-tolerated and supported normal growth. Compared to infants who received the unsupplemented control formula, infants who received prebiotic supplementation experienced a softer stooling pattern similar to that reported in breastfed infants.Trial registrationClinicalTrials.gov Identifier: NCT00712608
Highlights
To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infant populations [1], adjustments in level of fat, protein, carbohydrate, vitamins and minerals, iron, electrolytes, or other optional ingredients may be warranted as the composition of human milk is better defined
We previously demonstrated that a cow’s milk-based infant formula supplemented with a new prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) (1:1 ratio at a level of 4 g/L) was well-tolerated, supported normal growth, promoted a stool consistency closer to that of breastfed infants, [9] and produced soft stools and a bifidogenic effect closer to breast milk when compared to infants fed an unsupplemented formula [12] indicating that the PDX and GOS blend meets the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the Food and Agriculture Organization of the United Nations (FAO) definition of a prebiotic [13,14]
We evaluated the effect of infant formulas with adjustments in fat, carbohydrate, and calcium composition as well as supplementation with 4 g/L of the prebiotic blend of PDX and GOS or GOS alone on overall growth and tolerance in healthy term infants from 14 to 120 days of age
Summary
To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infant populations [1], adjustments in level of fat (including levels of long-chain polyunsaturated fatty acids, or LCPUFAs), protein, carbohydrate, vitamins and minerals, iron, electrolytes, or other optional ingredients may be warranted as the composition of human milk is better defined. Prebiotics share functional attributes with HMOs and are defined as “a selectively fermented ingredient that allows specific changes, both in the composition and/or activity in the gastrointestinal microbiota that confers benefits upon host well-being and health [6].”. These beneficial effects include but are not limited to the following: a) increased beneficial bacteria (e.g. bifidobacteria); b) decreased pathogenic bacteria; and c) an improved laxation pattern (e.g. softer stools) [7,8,9,10,11]. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow’s milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone
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