2.2. Trial Interventions
breast milk
Intervention products were bovine-milk-based infant formulas manufactured by Wyeth Nutrition, Askeaton, Ireland, containing a selected blend of nutrients naturally occurring in breast milk and hypothesized to promote myelination based on observational and in vitro findings. Both intervention products included the same organoleptic and sensory characteristics to secure blinding and contained the same blend of nutrients but at different levels. The investigational products contained higher levels of DHA, ARA, iron (fortified through ferrous sulfate heptahydrate), folic acid and vitamin B12 (fortified through cyanocobalamine), and an alpha-lactalbumin-enriched whey protein concentrate with higher levels of sphingomyelin and phospholipids than the control product due to the ingredients’ unique manufacturing process. Nutrient levels in the investigational products as well as in breast milk of the study population have been reported previously [