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An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial
Lipids are essential for healthy infant growth and development. The structural complexity of lipids in human milk is not present in infant milk formula (IF). A concept IF was developed mimicking more closely the structure and composition of human milk fat globules. The current study evaluates whethe...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8838783/ https://www.ncbi.nlm.nih.gov/pubmed/35276993 http://dx.doi.org/10.3390/nu14030634 |
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author | Teoh, Oon Hoe Lin, Tan Pih Abrahamse-Berkeveld, Marieke Winokan, Antoinette Chong, Yap Seng Yap, Fabian Marintcheva-Petrova, Maya van der Beek, Eline M. Shek, Lynette P. |
author_facet | Teoh, Oon Hoe Lin, Tan Pih Abrahamse-Berkeveld, Marieke Winokan, Antoinette Chong, Yap Seng Yap, Fabian Marintcheva-Petrova, Maya van der Beek, Eline M. Shek, Lynette P. |
author_sort | Teoh, Oon Hoe |
collection | PubMed |
description | Lipids are essential for healthy infant growth and development. The structural complexity of lipids in human milk is not present in infant milk formula (IF). A concept IF was developed mimicking more closely the structure and composition of human milk fat globules. The current study evaluates whether a concept IF with large, milk phospholipid-coated lipid droplets (mode diameter 3 to 5 μm) is equivalent to standard IF with regard to growth adequacy and safety in healthy, term Asian infants. In this randomized, double-blind, controlled trial, infants were randomized after parents decided to introduce formula. Infants received a standard IF with (Control) or without the specific prebiotic mixture scGOS/lcFOS (9:1 ratio; Control w/o prebiotics), or a Concept IF with large, milk phospholipid-coated lipid droplets and the prebiotic mixture. A group of 67 breastfed infants served as a reference. As a priori defined, only those infants who were fully intervention formula-fed ≤28 days of age were included in the equivalence analysis (Control n = 29; Control w/o prebiotics n = 28; Concept n = 35, per-protocol population). Primary outcome was daily weight gain during the first four months of life, with the difference between the Concept and Control as the key comparison of interest. Additionally, adverse events, growth and tolerance parameters were evaluated. Equivalence of daily weight gain was demonstrated between the Concept and Control group after additional correction for ethnicity and birthweight (difference in estimated means of 0.1 g/d, 90%CI [−2.30, 2.47]; equivalence margin +/− 3 g/d). No clinically relevant group differences were observed in secondary growth outcomes, tolerance outcomes or number, severity or relatedness of adverse events. This study corroborates that an infant formula with large, milk phospholipid-coated lipid droplets supports adequate growth and is well tolerated and safe for use in healthy infants. |
format | Online Article Text |
id | pubmed-8838783 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-88387832022-02-13 An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial Teoh, Oon Hoe Lin, Tan Pih Abrahamse-Berkeveld, Marieke Winokan, Antoinette Chong, Yap Seng Yap, Fabian Marintcheva-Petrova, Maya van der Beek, Eline M. Shek, Lynette P. Nutrients Article Lipids are essential for healthy infant growth and development. The structural complexity of lipids in human milk is not present in infant milk formula (IF). A concept IF was developed mimicking more closely the structure and composition of human milk fat globules. The current study evaluates whether a concept IF with large, milk phospholipid-coated lipid droplets (mode diameter 3 to 5 μm) is equivalent to standard IF with regard to growth adequacy and safety in healthy, term Asian infants. In this randomized, double-blind, controlled trial, infants were randomized after parents decided to introduce formula. Infants received a standard IF with (Control) or without the specific prebiotic mixture scGOS/lcFOS (9:1 ratio; Control w/o prebiotics), or a Concept IF with large, milk phospholipid-coated lipid droplets and the prebiotic mixture. A group of 67 breastfed infants served as a reference. As a priori defined, only those infants who were fully intervention formula-fed ≤28 days of age were included in the equivalence analysis (Control n = 29; Control w/o prebiotics n = 28; Concept n = 35, per-protocol population). Primary outcome was daily weight gain during the first four months of life, with the difference between the Concept and Control as the key comparison of interest. Additionally, adverse events, growth and tolerance parameters were evaluated. Equivalence of daily weight gain was demonstrated between the Concept and Control group after additional correction for ethnicity and birthweight (difference in estimated means of 0.1 g/d, 90%CI [−2.30, 2.47]; equivalence margin +/− 3 g/d). No clinically relevant group differences were observed in secondary growth outcomes, tolerance outcomes or number, severity or relatedness of adverse events. This study corroborates that an infant formula with large, milk phospholipid-coated lipid droplets supports adequate growth and is well tolerated and safe for use in healthy infants. MDPI 2022-02-01 /pmc/articles/PMC8838783/ /pubmed/35276993 http://dx.doi.org/10.3390/nu14030634 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Teoh, Oon Hoe Lin, Tan Pih Abrahamse-Berkeveld, Marieke Winokan, Antoinette Chong, Yap Seng Yap, Fabian Marintcheva-Petrova, Maya van der Beek, Eline M. Shek, Lynette P. An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial |
title | An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial |
title_full | An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial |
title_fullStr | An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial |
title_full_unstemmed | An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial |
title_short | An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial |
title_sort | infant formula with large, milk phospholipid-coated lipid droplets supports adequate growth and is well-tolerated in healthy, term asian infants: a randomized, controlled double-blind clinical trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8838783/ https://www.ncbi.nlm.nih.gov/pubmed/35276993 http://dx.doi.org/10.3390/nu14030634 |
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