PMID- 35242798
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220502
IS  - 2296-861X (Print)
IS  - 2296-861X (Electronic)
IS  - 2296-861X (Linking)
VI  - 9
DP  - 2022
TI  - A Nutrient Formulation Affects Developmental Myelination in Term Infants: A 
      Randomized Clinical Trial.
PG  - 823893
LID - 10.3389/fnut.2022.823893 [doi]
LID - 823893
AB  - BACKGROUND AND OBJECTIVES: Observational studies suggest differences between 
      breast-fed and formula-fed infants in developmental myelination, a key brain 
      process for learning. The study aims to investigate the efficacy of a blend of 
      docosahexaenoic acid (DHA), arachidonic acid (ARA), iron, vitamin B12, folic 
      acid, and sphingomyelin (SM) from a uniquely processed whey protein concentrate 
      enriched in alpha-lactalbumin and phospholipids compared with a control 
      formulation on myelination, cognitive, and behavioral development in the first 6 
      months of life. METHODS: These are 6-month results from an ongoing two-center, 
      randomized controlled trial with a 12-month intervention period (completed for 
      all participants). In this study, full term, neurotypical infants of both sexes 
      (N = 81) were randomized into investigational (N = 42) or control groups (N = 
      39). In addition, non-randomized breast-fed children (N = 108) serve as a natural 
      reference group. Main outcomes are myelination (MRI), cognitive (Bayley Scales of 
      Infant and Toddler Development, 3rd edition [Bayley-III]), social-emotional 
      development (Ages and Stages Questionnaires: Social-Emotional, 2nd edition 
      [ASQ:SE-2]), sleep (Brief Infant Sleep Questionnaire [BISQ]), and safety (growth 
      and adverse events [AEs]). RESULTS: The full analyses set comprises N = 66 
      infants. Significant differences in myelin structure, volume, and rate of 
      myelination were observed in favor of the investigational myelin blend at 3 and 6 
      months of life. Effects were demonstrated for whole brain myelin and for 
      cerebellar, parietal, occipital, and temporal regions, known to be functionally 
      involved in sensory, motor, and language skills. No statistically significant 
      differences were found for early behavior and cognition scores. CONCLUSIONS: This 
      is the first study demonstrating the efficacy of a myelin nutrient blend in 
      well-nourished, term infants on developmental myelination, which may be 
      foundational for later cognitive and learning outcomes. CLINICAL TRIAL 
      REGISTRATION: ClinicalTrials.gov, identifier: NCT03111927.
CI  - Copyright (c) 2022 Schneider, Bruchhage, O'Neill, Hartweg, Tanguy, Steiner, 
      Mutungi, O'Regan, Mcsweeney, D'Sa and Deoni.
FAU - Schneider, Nora
AU  - Schneider N
AD  - Nestle Institute of Health Sciences, Nestle Research, Societe des Produits Nestle 
      SA, Lausanne, Switzerland.
FAU - Bruchhage, Muriel M K
AU  - Bruchhage MMK
AD  - Department of Pediatrics, Brown University, Providence, RI, United States.
AD  - Rhode Island Hospital, Hasbro Children's Hospital, Providence, RI, United States.
AD  - Department of Psychology, Stavanger University, Stavanger, Norway.
FAU - O'Neill, Barry V
AU  - O'Neill BV
AD  - Nestle Institute of Health Sciences, Nestle Research, Societe des Produits Nestle 
      SA, Lausanne, Switzerland.
FAU - Hartweg, Mickael
AU  - Hartweg M
AD  - Clinical Research Unit, Nestle Research, Societe des Produits Nestle SA, 
      Lausanne, Switzerland.
FAU - Tanguy, Jerome
AU  - Tanguy J
AD  - Clinical Research Unit, Nestle Research, Societe des Produits Nestle SA, 
      Lausanne, Switzerland.
FAU - Steiner, Pascal
AU  - Steiner P
AD  - Nestle Institute of Health Sciences, Nestle Research, Societe des Produits Nestle 
      SA, Lausanne, Switzerland.
FAU - Mutungi, Gisella
AU  - Mutungi G
AD  - Nestle Nutrition, Societe des Produits Nestle SA, Vevey, Switzerland.
FAU - O'Regan, Jonathan
AU  - O'Regan J
AD  - Nestle Development Centre Nutrition, Askeaton, Ireland.
FAU - Mcsweeney, Seamus
AU  - Mcsweeney S
AD  - Nestle Development Centre Nutrition, Askeaton, Ireland.
FAU - D'Sa, Viren
AU  - D'Sa V
AD  - Department of Pediatrics, Brown University, Providence, RI, United States.
AD  - Rhode Island Hospital, Hasbro Children's Hospital, Providence, RI, United States.
FAU - Deoni, Sean C L
AU  - Deoni SCL
AD  - Department of Pediatrics, Brown University, Providence, RI, United States.
AD  - Rhode Island Hospital, Hasbro Children's Hospital, Providence, RI, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT03111927
PT  - Journal Article
DEP - 20220210
PL  - Switzerland
TA  - Front Nutr
JT  - Frontiers in nutrition
JID - 101642264
PMC - PMC8886575
OTO - NOTNLM
OT  - MRI
OT  - brain development
OT  - infant nutrition
OT  - myelination
OT  - phospholipids
COIS- This study received funding from the Societe des Produits Nestle SA. The funder 
      had the following involvement with the study: study design, data collection, and 
      analysis, decision to publish, and preparation of the manuscript. NS, BO'N, MH, 
      JT, PS, and GM were employed by Societe des Produits Nestle SA. JO'R and SM were 
      employed by Nestle Development Centre Nutrition, Ireland The remaining authors 
      declare that the research was conducted in the absence of any commercial or 
      financial relationships that could be construed as a potential conflict of 
      interest.
EDAT- 2022/03/05 06:00
MHDA- 2022/03/05 06:01
PMCR- 2022/01/01
CRDT- 2022/03/04 05:42
PHST- 2021/11/28 00:00 [received]
PHST- 2022/01/04 00:00 [accepted]
PHST- 2022/03/04 05:42 [entrez]
PHST- 2022/03/05 06:00 [pubmed]
PHST- 2022/03/05 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fnut.2022.823893 [doi]
PST - epublish
SO  - Front Nutr. 2022 Feb 10;9:823893. doi: 10.3389/fnut.2022.823893. eCollection 
      2022.