Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety
Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infan...
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Published in | Nutrition journal Vol. 9; no. 1; p. 22 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
London
BioMed Central
21.05.2010
BioMed Central Ltd BMC |
Subjects | |
Online Access | Get full text |
ISSN | 1475-2891 1475-2891 |
DOI | 10.1186/1475-2891-9-22 |
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Abstract | Background/Objectives
Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification.
Subjects/Methods
This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two (232) infants ≤ 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16.
Results
Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar.
Conclusions
Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. |
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AbstractList | Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification.BACKGROUND/OBJECTIVESBreast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification.This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold+Lutein). Two hundred thirty-two (232) infants<or=14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16.SUBJECTS/METHODSThis 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold+Lutein). Two hundred thirty-two (232) infants<or=14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16.Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar.RESULTSInfants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar.Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula.CONCLUSIONSInfants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. Abstract Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Subjects/Methods This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two (232) infants ≤ 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Results Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Subjects/Methods This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two (232) infants ≤ 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Results Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold+Lutein). Two hundred thirty-two (232) infants<or=14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Subjects/Methods This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two (232) infants [less than or equal to] 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Results Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula. |
ArticleNumber | 22 |
Audience | Academic |
Author | Gepanayao, Connie P Harris, Bruce J Capeding, Rosario Stouffer, Nicole Davis, Anne M Calimon, Nerrisa Lebumfacil, Jowena |
AuthorAffiliation | 5 Stouffer & Associates, 8 Wellesley Way, Medford, NJ 08055, USA 6 Pfizer (formerly Wyeth) Nutrition, 200 Campus Drive, Collegeville, PA 19426, USA 1 Asian Hospital and Medical Center, Medical Office Building, Civic Drive, Filinvest, Alabang, Muntinlupa City, Philippines 1781 2 Pulo Health Center, Cabuyao, Laguna, Philippines 3 Wyeth Philippines, 2236 Chino Roces Avenue, Makati City, Philippines 1200 4 Martek, Baltimore, MD, USA |
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Author_xml | – sequence: 1 givenname: Rosario surname: Capeding fullname: Capeding, Rosario organization: Asian Hospital and Medical Center – sequence: 2 givenname: Connie P surname: Gepanayao fullname: Gepanayao, Connie P organization: Pulo Health Center – sequence: 3 givenname: Nerrisa surname: Calimon fullname: Calimon, Nerrisa organization: Wyeth Philippines – sequence: 4 givenname: Jowena surname: Lebumfacil fullname: Lebumfacil, Jowena organization: Wyeth Philippines – sequence: 5 givenname: Anne M surname: Davis fullname: Davis, Anne M organization: Martek – sequence: 6 givenname: Nicole surname: Stouffer fullname: Stouffer, Nicole organization: Stouffer & Associates – sequence: 7 givenname: Bruce J surname: Harris fullname: Harris, Bruce J email: harrisb@wyeth.com organization: Pfizer (formerly Wyeth) Nutrition |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20492710$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1016/0378-3782(89)90057-1 10.1007/s00394-003-0403-9 10.1006/abbi.2000.2184 10.1006/abbi.2000.2171 10.1016/j.nutres.2007.04.020 |
ContentType | Journal Article |
Copyright | Capeding et al; licensee BioMed Central Ltd. 2010 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. COPYRIGHT 2010 BioMed Central Ltd. Copyright ©2010 Capeding et al; licensee BioMed Central Ltd. 2010 Capeding et al; licensee BioMed Central Ltd. |
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Keywords | Lutein Head Circumference Zeaxanthin Breast Milk Carotenoid |
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References_xml | – volume: 1 start-page: 25 issue: 1 year: 2007 ident: 278_CR3 publication-title: Clinical Ophthalmology – volume: 71 start-page: 147 issue: 3 year: 2000 ident: 278_CR6 publication-title: Optometry – volume: 19 start-page: 223 year: 1989 ident: 278_CR13 publication-title: Early Hum Dev doi: 10.1016/0378-3782(89)90057-1 – volume-title: Nutrition Research Institute - Philippine Pediatric Society (FNRI - PPS) Anthropometric Tables and Charts for Filipino Children year: 1992 ident: 278_CR11 – ident: 278_CR12 – ident: 278_CR5 – ident: 278_CR10 – ident: 278_CR14 – volume: 42 start-page: 133 year: 2003 ident: 278_CR7 publication-title: Eur J Nutr doi: 10.1007/s00394-003-0403-9 – volume: 385 start-page: 41 year: 2001 ident: 278_CR1 publication-title: Arch Biochem Biophys doi: 10.1006/abbi.2000.2184 – start-page: 223 volume-title: Handbook of antioxidants year: 2002 ident: 278_CR4 – volume: 385 start-page: 28 year: 2001 ident: 278_CR2 publication-title: Arch Biochem Biophys doi: 10.1006/abbi.2000.2171 – volume: 54 start-page: 49 year: 2006 ident: 278_CR9 publication-title: WHO Food Additives Series – volume: 27 start-page: 449 year: 2007 ident: 278_CR8 publication-title: Nutrition Research doi: 10.1016/j.nutres.2007.04.020 – reference: 11361022 - Arch Biochem Biophys. 2001 Jan 1;385(1):28-40 – reference: 11361024 - Arch Biochem Biophys. 2001 Jan 1;385(1):41-6 – reference: 11183293 - Adv Data. 2000 Jun 8;(314):1-27 – reference: 12811470 - Eur J Nutr. 2003 Jun;42(3):133-41 – reference: 10970259 - Optometry. 2000 Mar;71(3):147-64 – reference: 19668463 - Clin Ophthalmol. 2007 Mar;1(1):25-35 – reference: 2806151 - Early Hum Dev. 1989 Jul;19(4):223-39 |
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Snippet | Background/Objectives
Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small... Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein... Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small... Abstract Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has... |
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SubjectTerms | Body Height Cephalometry Child development Clinical Nutrition Double-Blind Method Female Food and nutrition Growth Health aspects Health Promotion and Disease Prevention Humans Infant Formula - administration & dosage Infant Formula - chemistry Infant, Newborn - growth & development Infants Lutein - administration & dosage Lutein - adverse effects Male Maternal Age Medicine Medicine & Public Health Philippines Prospective Studies Weight Gain - drug effects |
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Title | Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety |
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