Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial - 21/11/19
, Carol Lynn Berseth, MD 2, 3, Cheryl L. Harris, MS 2, James D. Richards, PhD 4, 5, Jennifer L. Wampler, PhD 2, Weihong Zhuang, MS 2, Geoffrey Cleghorn, MD 2, 6, Colin D. Rudolph, MD, PhD 2, 7, Bryan Liu, MD, PhD 2, 8, D. Jill Shaddy, MA 9, John Colombo, PhD 9Abstract |
Objective |
To evaluate neurodevelopment, growth, and health outcomes in infants receiving bovine milk fat globule membrane (MFGM) and lactoferrin in infant formula.
Study design |
Healthy term infants were randomized to a cow's milk-based infant formula or MFGM + LF (a similar infant formula, with an added source of bovine milk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5 g/L] and bovine lactoferrin [0.6 g/L]) through 365 days of age. The Bayley Scales of Infant Development, 3rd edition cognitive composite score at day 365 was the primary outcome. Secondary outcomes included tolerance measures through day 365, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events through day 545.
Results |
Of 451 infants enrolled (control, 228; MFGM + LF, 223), 291 completed study feeding and Bayley-III testing at day 365 (control, 148; MFGM + LF, 143). The mean cognitive (+8.7), language (+12.3), and motor (+12.6) scores were higher (P < .001) for the MFGM + LF group; no differences were observed at day 545. Global development scores from day 120 to day 275 and attention at day 365 were significantly improved. Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P < .05) in the MFGM + LF group. The overall incidence of respiratory-associated adverse events and diarrhea were significantly lower for the MFGM + LF group through day 545.
Conclusions |
Infants receiving formula with added bovine MFGM and bovine lactoferrin had an accelerated neurodevelopmental profile at day 365 and improved language subcategories at day 545. Formulas were associated with age-appropriate growth and significantly fewer diarrhea and respiratory-associated adverse events through 545 days of age.
Trial registration Clinicaltrials.gov: |
NCT02274883.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : AE, ASQ, Bayley-III, CDI, MFGM, bMFGM
Mappa
| Funded by Mead Johnson Nutrition (Evansville, IN). Shanghai Jiaotong University School of Medicine was provided funding to implement neurodevelopmental testing and study site coordination. J.C. and D.S. received travel funds to provide training in neurodevelopmental testing. S.W., J.W., G.C., C.H., and W.Z. are employees of Mead Johnson Nutrition. C.B., J.R., C.R., and B.L. were previously employed at Mead Johnson Nutrition. |
Vol 215
P. 24 - dicembre 2019 Ritorno al numero
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