Pediatr Gastroenterol Hepatol Nutr.  2014 Jun;17(2):104-111.

Growth and Tolerance Assessment of a Lutein-fortified Infant Formula

• Kon IY
• Gmoshinskaya MV
• Safronova
• Alarcon P
• Vandenplas Y

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+/-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.
CONCLUSION
This study demonstrated that lutein-fortified formula is safe, well-tolerated and supported physical growth of evaluated infants.

Keyword

Infant formula; Lutein; Gastrointestinal tolerance; Safety

MeSH Terms

Abdominal Pain
Academies and Institutes
beta Carotene
Child
Colic
Follow-Up Studies
Humans
Infant
Infant Formula*
Informed Consent
Lutein
Nucleotides
Parents
Prebiotics
Probiotics
Weight Gain
Lutein
Nucleotides
Prebiotics
beta Carotene

Figure

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  Fig. 1 Z-score weight/age: before and after intervention. WHO: World Health Organization.

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  Fig. 2 Z-score weight for length/height: before and after intervention. WHO: World Health Organization.

Reference

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; 1:71–78.

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; 41:584–599.

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; 385:41–46.

4. Landrum JT, Bone RA. Lutein, zeaxanthin, and the macular pigment. Arch Biochem Biophys. 2001; 385:28–40.

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; 29:735–743.

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; 58:90–97.

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; 42:133–141.

9. Stahl W, Sies H. Antioxidant effects of carotenoids. In : Cadenas E, Packer L, editors. Handbook of antioxidants. 2nd ed. New York: Marcel Dekker Inc.;2002. p. 223–233.

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. Volume 1. Resolutions and records. Final. In : Thirty-ninth World Health Assembly; Geneva; 5-16 May 1986. Geneva: World Health Organization;1986. p. 122–135. WHA39/1986/REC/1, annex 6.

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.

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. 57:585–586.

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; 93:1945–1952.

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.

18. Vishwanathan R, Kuchan M, Johnson E. Lutein is the predominant carotenoid in infant brain. Acta Biol Crac Ser Bot. 2011; 53:Suppl 1. 29.