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Growth and Tolerance Assessment of a Lutein-fortified Infant Formula

  • Kon, Igor Ya. (Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences) ;
  • Gmoshinskaya, Maria V. (Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences) ;
  • Safronova, Adilya I. (Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences) ;
  • Alarcon, Pedro (National Institute of Child Health) ;
  • Vandenplas, Yvan (Department of Pediatrics, Universitair Ziekenhuis Brussel, Vrije Universiteit)
  • Received : 2013.12.31
  • Accepted : 2014.03.04
  • Published : 2014.06.30

Abstract

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.

Keywords

References

  1. Abolyan LV. The breastfeeding support and promotion in Baby-Friendly Maternity Hospitals and Not-as-Yet Baby-Friendly Hospitals in Russia. Breastfeed Med 2006;1:71-8. https://doi.org/10.1089/bfm.2006.1.71
  2. Koletzko B, Baker S, Cleghorn G, Neto UF, Gopalan S, Hernell O, et al. Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group. J Pediatr Gastroenterol Nutr 2005;41:584-99. https://doi.org/10.1097/01.mpg.0000187817.38836.42
  3. Hammond BR Jr, Wooten BR, Curran-Celentano J. Carotenoids in the retina and lens: possible acute and chronic effects on human visual performance. Arch Biochem Biophys 2001;385:41-6. https://doi.org/10.1006/abbi.2000.2184
  4. Landrum JT, Bone RA. Lutein, zeaxanthin, and the macular pigment. Arch Biochem Biophys 2001;385: 28-40. https://doi.org/10.1006/abbi.2000.2171
  5. Ham WT Jr, Mueller HA, Ruffolo JJ Jr, Clarke AM. Sensitivity of the retina to radiation damage as a function of wavelength. Photochem Photobiol 1979;29: 735-43. https://doi.org/10.1111/j.1751-1097.1979.tb07759.x
  6. Zimmer JP, Hammond BR Jr. Possible influences of lutein and zeaxanthin on the developing retina. Clin Ophthalmol 2007;1:25-35.
  7. Jewell VC, Mayes CB, Tubman TR, Northrop-Clewes CA, Thurnham DI. A comparison of lutein and zeaxanthin concentrations in formula and human milk samples from Northern Ireland mothers. Eur J Clin Nutr 2004;58:90-7. https://doi.org/10.1038/sj.ejcn.1601753
  8. Canfield LM, Clandinin MT, Davies DP, Fernandez MC, Jackson J, Hawkes J, et al. Multinational study of major breast milk carotenoids of healthy mothers. Eur J Nutr 2003;42:133-41.
  9. Stahl W, Sies H. Antioxidant effects of carotenoids. In: Cadenas E, Packer L, eds. Handbook of antioxidants. 2nd ed. New York: Marcel Dekker Inc., 2002:223-33.
  10. National Research Council. Infant formula: evaluating the safety of new ingredients. Washington, DC: The National Academies Press, 2004.
  11. Codex Alimentarius Commission of FAO/WHO. Rome: Codex Alimentarius Commission. Available from: http://www.codexalimentarius.org.
  12. European Union Commission. European Union Commission Directive. Brussels: European Union Commission; 2013. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:230:0016:0019:EN:PDF.
  13. World Health Organization. Resolution WHA 39.28. Infant and young child feeding. In: Thirty-ninth World Health Assembly, Geneva, 5-16 May 1986. Volume 1. Resolutions and records. Final. Geneva: World Health Organization, 1986. WHA39/1986/REC/1, annex 6: 122-35.
  14. Raikos V, Dassios T. Health-promoting properties of bioactive peptides derived from milk proteins in infant food: a review. Dairy Sci Technol 2014;94:91-101. https://doi.org/10.1007/s13594-013-0152-3
  15. Williams T, Choe Y, Price P, Katz G, Boff J, Suarez F, et al. Safety and tolerance of infant formulas containing prebiotics in healthy term infants. Microb Ecol 57:585-6.
  16. Mackey AD, Albrecht D, Oliver J, Williams T, Long AC, Price PT. Plasma carotenoid concentrations of infants are increased by feeding a milk-based infant formula supplemented with carotenoids. J Sci Food Agric 2013;93:1945-52. https://doi.org/10.1002/jsfa.5996
  17. Capeding R, Gepanayao CP, Calimon N, Lebumfacil J, Davis AM, Stouffer N, et al. Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety. Nutr J 2010;9:22. https://doi.org/10.1186/1475-2891-9-22
  18. Vishwanathan R, Kuchan M, Johnson E. Lutein is the predominant carotenoid in infant brain. Acta Biologica Cracoviensia 2011;53(Suppl 1):29.

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