title: Growth and Tolerance Assessment of a Lutein-fortified Infant Formula.
abstract: OBJECTIVE
  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±0.4 on study-day 14 and 1.8±0.5 on study-day 28. The mean daily weight gain was 30.9±3.8 grams and the mean length gain during the 28 days of follow up was 3.1±0.8 cm, 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.
  
  
  CONCLUSIONS
  This study demonstrated that lutein-fortified formula is safe, well-tolerated and supported physical growth of evaluated infants.
authors: Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences, Moscow, Russian Federation.
authors: Igor Ya
authors: IY
authors: Kon
authors: Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences, Moscow, Russian Federation.
authors: Maria V
authors: MV
authors: Gmoshinskaya
authors: Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences, Moscow, Russian Federation.
authors: Adilya I
authors: AI
authors: Safronova
authors: National Institute of Child Health, Lima, Peru.
authors: Pedro
authors: P
authors: Alarcon
authors: Department of Pediatrics, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
authors: Yvan
authors: Y
authors: Vandenplas
keywords: Gastrointestinal tolerance; Infant formula; Lutein; Safety