A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial

Abstract

Background and ObjectivesObservational 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.MethodsThese 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]).ResultsThe 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.ConclusionsThis 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 RegistrationClinicalTrials.gov, identifier: NCT03111927.

Deficits in neural encoding of speech in preterm infants

“…Myelination and synaptogenesis are two fundamental processes in the nervous system that peak in the perinatal period of development ( Kinney and Volpe, 2017 , Kostović and Jovanov-Milošević, 2006 , Moore and Linthicum, 2001 ). Preterm birth deprives the infant brain of fatty acids and iron that are normally accrued in the last trimester of pregnancy ( Georgieff and Innis, 2005 , Koudelka et al, 2016 , Schneider et al, 2022 ). This deprivation can lead to pathological changes in the activity of astrocytes and microglia that prevent pre-oligodendrocyte differentiation, which in turn results in hypomyelination ( Volpe, 2019 ).…”

A hydrolyzed lipid blend diet promotes myelination in neonatal piglets in a region and concentration‐dependent manner

“…Human neuroimaging studies have shown that breast-fed infants exhibit greater overall myelination and better cognitive performance later in life compared to formula-fed infants (Deoni et al, 2013(Deoni et al, , 2018, which could be attributed to enhanced lipid composition or nutrient bioavailability in breast milk (Chiurazzi et al, 2021;Garwolińska et al, 2018;Haschke et al, 2016;Koletzko, 2016). In particular, compounds vital for myelin development such as sphingomyelin, gangliosides, and folic acid differ between breast milk and infant formula (Schneider et al, 2022). The interpretation of the data presented here may also be limited by differences in non-dietary factors, most notably rearing (sow-reared vs. individually housed in a facility) and maternal separation.…”

Deficits in neural encoding of speech in preterm infants

“…Myelination and synaptogenesis are two fundamental processes in the nervous system that peak in the perinatal period of development (Kinney & Volpe, 2017;Kostović & Jovanov-Milošević, 2006;Moore & Linthicum, 2001). Preterm birth deprives the infant brain of fatty acids and iron that are normally accrued in the last trimester of pregnancy (Georgieff & Innis, 2005;Koudelka et al, 2016;Schneider et al, 2022). This deprivation can lead to pathological changes in the activity of astrocytes and microglia that prevent preoligodendrocyte differentiation, which in turn results in hypomyelination (Volpe, 2019).…”