Growth and Tolerance Assessment of a Lutein-fortified Infant Formula

Purpose: To evaluate safety, gastrointestinal tolerance, and growth of a new experimental starter formula (NESF) fortified with lutein, prebiotics, probiotics, nucleotides and beta-carotene, fed to infants within the first months of life. Methods: This was a non-randomized, open, uncontrolled study conducted from December 2010 to May 2011. Twenty-three healthy infants aged 10 days to 2 months old were enrolled. Outcomes included gastrointestinal tolerance, physical growth and safety. Prior to the initiation of the trial, the Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences confirmed that the NESF met all safety and nutritional parameters. Results: NESF was well tolerated. The majority of infants fed this formula passed semi-liquid, yellow or yellow-brown. The mean stool frequency/day was $2.5{\pm}0.4$ on study-day 14 and $1.8{\pm}0.5$ on study-day 28. The mean daily weight gain was $30.9{\pm}3.8$ grams and the mean length gain during the 28 days of follow up was $3.1{\pm}0.8cm$, corresponding to the average physical growth normally seen in the first months of life in Russian infants. Six children left the study: one refused to drink the formula, one left the study as parents changed residence; and one child's parents have recalled their informed consent due to adverse event unrelated to the product. Three infants presented adverse events possibly related to the product (rash; colic and abdominal pain; constipation). Seventeen infants completed the trial. Conclusion: This study demonstrated that lutein-fortified formula is safe, well-tolerated and supported physical growth of evaluated infants.