Infant growth and tolerance with a formula based on novel native demineralized whey: A randomized double-blind pilot study.

Objectives: The aim of the study was to evaluate the effects on infant growth and tolerance of a Test infant formula based on a novel whey extraction and demineralization process, compared to a Standard formula and a breastfed reference arm.

Methods: Healthy term infants (n = 61) aged up to 21 days were randomized to Test or Control formula. A breastfed group (n = 39) served as a reference. Growth, tolerance, adverse events, and sleep were evaluated every month until 6 months of age. Plasma amino-acid concentrations at 3 months of age were measured in a subgroup population.

Results: Growth curves of all infants globally agreed with World Health Organization standards across the 6-month period study. Regarding tolerance, no difference between the formula-fed groups was observed on daily number of crying episodes, intensity or time to onset of regurgitations, and stool frequency or consistency, except at 5 months with infants in the Control group having more watery stools. Plasma concentration of some amino acids differed between the groups, especially tryptophan concentration which was higher in infants fed with the Test formula. In parallel, total sleep duration was longer in these infants at 2, 3, and 5 months of age, corresponding to an increase in daytime sleep.

Conclusions: Test formula supported an adequate infant growth from birth to 6 months of age and was well-tolerated by all infants. An increase in total sleep at several months was also observed with the Test formula.