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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-02-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/14/3/634 |
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| author | Oon Hoe Teoh Tan Pih Lin Marieke Abrahamse-Berkeveld Antoinette Winokan Yap Seng Chong Fabian Yap Maya Marintcheva-Petrova Eline M. van der Beek Lynette P. Shek |
| author_facet | Oon Hoe Teoh Tan Pih Lin Marieke Abrahamse-Berkeveld Antoinette Winokan Yap Seng Chong Fabian Yap Maya Marintcheva-Petrova Eline M. van der Beek Lynette P. Shek |
| author_sort | Oon Hoe Teoh |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T23:20:56Z |
| format | Article |
| id | doaj.art-dd02b71a61254033b410ea1cb4a30238 |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-09T23:20:56Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-dd02b71a61254033b410ea1cb4a302382023-11-23T17:27:02ZengMDPI AGNutrients2072-66432022-02-0114363410.3390/nu14030634An 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 TrialOon Hoe Teoh0Tan Pih Lin1Marieke Abrahamse-Berkeveld2Antoinette Winokan3Yap Seng Chong4Fabian Yap5Maya Marintcheva-Petrova6Eline M. van der Beek7Lynette P. Shek8Department of Paediatrics, KK Women’s and Children’s Hospital, Singapore 229899, SingaporeDepartment of Paediatrics, KK Women’s and Children’s Hospital, Singapore 229899, SingaporeDanone Nutricia Research, 3584 CT Utrecht, The NetherlandsNutricia Research, Singapore 138671, SingaporeSingapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore 119228, SingaporeDepartment of Paediatrics, KK Women’s and Children’s Hospital, Singapore 229899, SingaporeDanone Nutricia Research, 3584 CT Utrecht, The NetherlandsDepartment of Paediatrics, University Medical Centre Groningen, University of Groningen, 9700 RB Groningen, The NetherlandsSingapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore 119228, SingaporeLipids 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.https://www.mdpi.com/2072-6643/14/3/634lipid droplet structuresafetygrowth adequacyinfant formula |
| spellingShingle | Oon Hoe Teoh Tan Pih Lin Marieke Abrahamse-Berkeveld Antoinette Winokan Yap Seng Chong Fabian Yap Maya Marintcheva-Petrova Eline M. van der Beek Lynette P. Shek 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 Nutrients lipid droplet structure safety growth adequacy infant formula |
| 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 | lipid droplet structure safety growth adequacy infant formula |
| url | https://www.mdpi.com/2072-6643/14/3/634 |
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