Nutritive Efficacy and Safety of a Modified Infant Formula With a Reduced Protein Content and Improved Protein Quality

Formula contains significantly higher total protein concentrations than breast milk. Therefore formula-fed infants have a significantly higher total protein intake in the first few months compared to exclusively breast-fed infants. The aim is to examine the nutritive efficacy and safety of a modified infant formula with a reduced protein content and improved protein quality in a prospective, double-blind, controled, randomized study. Primary outcome measures are weight gain and growth of young infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the qualitative and quantitative changes in the protein content of the new formula will be recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group will be fed for 3 months with an infant formula with decreased protein content. At the same time the protein body of the new formula is modified by enrichment with bovine alpha-lactalbumin. A control group receives a isocaloric conventional infant formula and a protein body consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of alpha-lactalbumin over the same time-period. A group of breastmilk fed infants will serve as a reference group. In regular anthropometric controls growth and thriving of the study participants is documented and compared between the different groups.