Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition
Rosario Toro-Campos1, Cecilia Algarín2, Patricio Peirano2
1Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile. rosario.toro@inta.uchile.cl.
Insights
Adding bovine milk fat globule membranes (bMFGM) to infant formula may support healthy physical growth and brain development in early infancy. This study compared bMFGM-enriched formula to standard formula and human milk.
Area of Science:
- Pediatric Nutrition
- Infant Development
- Dairy Science
Background:
- Developing infant formula closer to human milk is a key goal in pediatric nutrition.
- Milk fat globule membranes (MFGM) contain functional components found in human milk.
- Bovine MFGM (bMFGM) addition to infant formula may offer benefits, narrowing the gap with human breast milk.
Purpose of the Study:
- To assess the impact of bMFGM-enriched infant formula on physical growth and brain development.
- To compare outcomes in infants fed bMFGM-enriched formula versus standard formula.
- To compare outcomes in formula-fed infants against a reference group fed mother's own milk.
Main Methods:
- A single-center, double-blind, parallel randomized controlled trial.
- Infants were fed either standard formula (SF) or bMFGM-enriched formula (EF) until 12 months of age.
- Primary outcomes included physical growth and cognitive development (Auditory Event-Related Potential) at 730 days.
Main Results:
- Results are pending, but the study aims to provide data on the effects of bMFGM in infant formula.
- The study will analyze physical growth (weight, length, head circumference) and cognitive development.
- Data will be analyzed for all participants randomized to each feeding group.
Conclusions:
- The study's findings will contribute to understanding the role of bMFGM in infant nutrition.
- Results are expected to inform the development of infant formulas that better support healthy growth and neurodevelopment.
- This research may help optimize infant formula composition for improved infant outcomes.
Background:
A central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk. Milk fat globule membranes (MFGM) have shown to have functional components that are found in human milk, suggesting that addition of bovine sources of MFGM (bMFGM) to infant formula may promote beneficial outcomes potentially helping to narrow the gap between infants who receive human breast milk or infant formula. The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and brain development when compared to infants fed with a standard formula and a reference group of infants fed with mother's own milk.
Methods:
Single center, double-blind, and parallel randomized controlled trial. Planned participant enrollment includes: infants exclusively receiving breast milk (n = 200; human milk reference group; HM) and infants whose mothers chose to initiate exclusive infant formula feeding before 4 months of age (n = 340). The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF). Primary outcomes will be: 1) Physical growth (Body weight, length, and head circumference) at 730 days of age; and 2) Cognitive development (Auditory Event-Related Potential) at 730 days of age. Data will be analyzed for all participants allocated to each study feeding group.
Discussion:
The results of this study will complement the knowledge regarding addition of bMFGM in infant formula including support of healthy growth and improvement of neurodevelopmental outcomes.
Trial Registration:
NCT02626143, registered on December 10th 2015.
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