Infant formula supplemented with milk fat globule membrane compared with standard infant formula for the cognitive development of healthy term-born formula-fed infants: protocol for a randomised controlled trial
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2024
Authors
Gould, J.F.
Gibson, R.A.
Yelland, L.N.
Colombo, J.
McPhee, A.J.
Gallier, S.
Roberts, R.M.
Shaddy, D.J.
Bednarz, J.
Makrides, M.
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BMJ Open, 2024; 14(6):e083399-1-e083399-13
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Jacqueline F Gould, Robert A Gibson, Lisa N Yelland, John Colombo, Andrew J McPhee, Sophie Gallier, Rachel M Roberts, D. Jill Shaddy, Jana Bednarz, Maria Makrides
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Abstract
Introduction Milk fat globule membrane (MFGM) is a complex lipid–protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective of this trial is to investigate whether providing infant formula enriched with MFGM versus standard infant formula improves cognitive development at 12 months of age in exclusively formulafed full-term infants. Methods and analysis This is a randomised, controlled, clinician-blinded, researcher-blinded and participantblinded trial of two parallel formula-fed groups and a breastfed reference group that were recruited in the suburban Adelaide (Australia) community by a single study centre (a medical research institute). Healthy, exclusively formula-fed, singleton, term-born infants under 8 weeks of age were randomised to either an MFGM-supplemented formula (intervention) or standard infant formula (control) from enrolment until 12 months of age. The reference group was not provided with formula. The primary outcome is the Cognitive Scale of the Bayley Scales of Infant Development, Fourth Edition (Bayley-IV) at 12 months. Secondary outcomes are the Bayley-IV Cognitive Scale at 24 months, other Bayley-IV domains (language, motor, emotional and behavioural development) at 12 and 24 months of age, infant attention at 4 and 9 months of age, parent-rated language at 12 and 24 months of age, parent-rated development at 6 and 18 months of age as well as growth, tolerance and safety of the study formula. To ensure at least 80% power to detect a 5-point difference in the mean Bayley-IV cognitive score, >200 infants were recruited in each group.
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© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.