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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...

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Autores principales: Kon, Igor Ya., Gmoshinskaya, Maria V., Safronova, Adilya I., Alarcon, Pedro, Vandenplas, Yvan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107217/
https://www.ncbi.nlm.nih.gov/pubmed/25061586
http://dx.doi.org/10.5223/pghn.2014.17.2.104
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author Kon, Igor Ya.
Gmoshinskaya, Maria V.
Safronova, Adilya I.
Alarcon, Pedro
Vandenplas, Yvan
author_facet Kon, Igor Ya.
Gmoshinskaya, Maria V.
Safronova, Adilya I.
Alarcon, Pedro
Vandenplas, Yvan
author_sort Kon, Igor Ya.
collection PubMed
description 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.
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spelling pubmed-41072172014-07-24 Growth and Tolerance Assessment of a Lutein-fortified Infant Formula Kon, Igor Ya. Gmoshinskaya, Maria V. Safronova, Adilya I. Alarcon, Pedro Vandenplas, Yvan Pediatr Gastroenterol Hepatol Nutr Original Article 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. The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition 2014-06 2014-06-30 /pmc/articles/PMC4107217/ /pubmed/25061586 http://dx.doi.org/10.5223/pghn.2014.17.2.104 Text en Copyright © 2014 by The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition http://creativecommons.org/licenses/by-nc/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kon, Igor Ya.
Gmoshinskaya, Maria V.
Safronova, Adilya I.
Alarcon, Pedro
Vandenplas, Yvan
Growth and Tolerance Assessment of a Lutein-fortified Infant Formula
title Growth and Tolerance Assessment of a Lutein-fortified Infant Formula
title_full Growth and Tolerance Assessment of a Lutein-fortified Infant Formula
title_fullStr Growth and Tolerance Assessment of a Lutein-fortified Infant Formula
title_full_unstemmed Growth and Tolerance Assessment of a Lutein-fortified Infant Formula
title_short Growth and Tolerance Assessment of a Lutein-fortified Infant Formula
title_sort growth and tolerance assessment of a lutein-fortified infant formula
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107217/
https://www.ncbi.nlm.nih.gov/pubmed/25061586
http://dx.doi.org/10.5223/pghn.2014.17.2.104
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