Title: An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants
|Ooh Hoe Teoh et al.
An Infant Formula with Large, Milk Phospholipid-Coated Lipid Droplets Supports Adequate Growth and Is Well-Tolerated in Healthy, Term Asian Infants: A Randomized, Controlled Double-Blind Clinical Trial
This publication in the journal Nutrients, shows that an infant formula (IF) concept with large, milk phospholipid coated lipid droplets (NUTURIS®)1 supports adequate growth, is well tolerated and safe for use in infants.
Human milk (HM) is the preferred source of nutrition for infants. In case exclusive breastfeeding is not possible, the provided infant formula (IF) must be safe and suitable to meet the nutritional requirements of infants, promoting a healthy growth and development.
To meet the substantial energy and nutrient intake demands of a newborn baby, human milk contains lipids, providing around 50% of the infant’s required energy.
One distinct characteristic of lipids in human milk is that they are present as large globules (a volume-based mode diameter of 3–5 μm) surrounded by a complex triple-layered phospholipid native membrane. In contrast, the lipids in currently available standard infant formulas are present as droplets that are generally 10 times smaller and mostly contain proteins at the lipid-water interface without any membrane.
Danone Research & Innovation developed an unique IF concept with large, milk phospholipid coated lipid droplets (mode diameter 3-5 μm; NUTURIS®)1 comprising only vegetable lipids.
A randomized, double-blind, controlled clinical trial in Singapore, the VENUS study2, investigates growth adequacy in Asian infants consuming an IF concept with NUTURIS® as the sole source of nutrition during their first four months of life as well as impact on gastrointestinal tolerance and adverse events.
To respect and support breastfeeding practices, infants in the VENUS study were randomised at the moment that parents decided that they wanted to introduce infant formula, which could occur anytime between 0-12 months. During data analysis, the infants randomised before 4 months were allocated to their respective intervention formula groups, whereas non-randomised infants or those randomised only after 4 months of age were part of the breastfed reference group.
In the publication, growth equivalence between intervention arms is evaluated in the subgroup of infants that were fully formula fed from 28 days of age onwards.
The tolerance and safety outcomes are evaluated in the full intervention group of infants randomised before 4 months of age (and only considering the data after study formula consumption had started).
The study included 3 intervention arms:
- Concept IF
(with NUTURIS® and a specific prebiotic mixture short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1))
- Control IF
(with a specific prebiotic mixture short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1))
- Control IF without prebiotics
(without the specific prebiotic mixture short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1))
as well as a group of breastfed infants as a reference.
The growth outcomes of the study demonstrate that there is an equivalence in daily weight gain from randomization to 17 weeks of age for the Concept vs. Control IF group, after additional correction for ethnicity and birthweight.
Compared to the breastfed reference group, equivalence in daily weight gain was demonstrated for the Concept and Control IF groups, but not for the Control without prebiotics IF group.
With respect to gastrointestinal tolerance outcomes, no clinically relevant group differences were observed between intervention groups. The mean stool consistency scores were lower for the concept IF compared to both control IFs, with values closer to the breastfed reference group.
In the safety evaluation, none of the reported adverse events were considered related to the study products. Differences observed in type of adverse events between intervention groups were not statistically significant nor clinically relevant, as such there was no safety concern related to the occurrence of any (serious) adverse events during the study.
To conclude, the IF concept with NUTURIS® supports adequate growth, is well tolerated and no major safety concerns were revealed based on the number, severity, relatedness, or type of (serious) adverse events observed during the first four months within this study. The potential long-term effect of lipid droplet characteristics in infant nutrition on growth trajectories, body composition and metabolic development, as well as other health outcomes, remains to be clarified.
Exclusive breastfeeding is recommended for infants up to 6 months of age, with continued breastfeeding thereafter in conjunction with appropriate complementary feeding until 2 years of age or beyond. HM substitutes (i.e., infant formula) should provide a safe and nutritionally adequate alternative if (full) breastfeeding is not possible. Nutrient levels in formula should ideally be adequate for all infants, while recognizing that optimal levels may not be the same for all, depending on genetic, other biological, and environmental factors.
Find out more about a study including an infant formula with large, milk phospholipid-coated lipid droplets in European infants ‘An infant formula with large, milk phospholipid-coated lipid droplets containing a mixture of dairy and vegetable lipids supports adequate growth and is well tolerated in healthy, term infants – PubMed (nih.gov)
1 Gallier S, Vocking K, Post J, et al. A novel infant milk formula concept: Mimicking the human milk fat globule structure. Colloids Surf B Biointerfaces. Published on 2015;136:329-339
2 Shek L.P., Chong Y.S., Winokan A. et al Evaluation of an infant formula with large, milk-phospholipid coated lipid dropets on long-term growth and development of Singaporean infants: randomised controlled trial protocol, Nutrients 2021, 13, 2865 https://doi.org/10.3390/nu13082865