Trial reportThe American journal of clinical nutrition2019
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.
Trial report in The American journal of clinical nutrition, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- The Association of Formula Protein Content and Growth in Early Infancy: A Systematic Review and Meta-Analysis.Nutrients · 2022Pooled it
- Milk Fat Globule Membrane Supplementation in Children: Systematic Review with Meta-Analysis.Nutrients · 2021Pooled it
- Anthropometry and Body Composition in Childhood: Follow-Up of a Randomised, Double-Blinded Controlled Trial With a Modified, Low-Protein Infant Formula During Infancy.Pediatric obesity · 2025Trial
- Milk phospholipid-coated lipid droplets modulate the infant gut microbiota and metabolome influencing weight gain.Microbiome · 2025Trial
- Formula with large, milk phospholipid-coated lipid droplets in late-moderate preterm infants: a double-blind RCT.Pediatric research · 2025Trial
- Safety and tolerance assessment of milk fat globule membrane-enriched infant formulas in healthy term Chinese infants: a randomised multicenter controlled trial.BMC pediatrics · 2022Trial
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- Absolute quantitative Lipidomics reveals lipid differences in milk fat globules of yak and German Simmental cattle.Food chemistry: X · 2025Article
- From liquid to solid: Exploring techniques, applications, and challenges of structured oils as fat replacements in food formulations.Comprehensive reviews in food science and food safety · 2025Review
- Article
- Tailored recommendations for infant milk formula intake results in more accurate feeding.European journal of pediatrics · 2024Article
- Infant formula containing large, milk phospholipid-coated lipid droplets and dairy lipids affects cognitive performance at school age.Frontiers in nutrition · 2023Article
- A Comparative Analysis of Lipid Digestion in Human Milk and Infant Formulas Based on Simulated In Vitro Infant Gastrointestinal Digestion.Foods (Basel, Switzerland) · 2022Article
- Article
- Review
- An Observational Cohort Study and Nested Randomized Controlled Trial on Nutrition and Growth Outcomes in Moderate and Late Preterm Infants (FLAMINGO).Frontiers in nutrition · 2021Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 9 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLipid droplets in human milk have a mode diameter of ∼4 μm and are surrounded by a native phospholipid-rich membrane. Current infant milk formulas (IMFs) contain small lipid droplets (mode diameter ∼0.5 μm) primarily coated by proteins. A concept IMF was developed mimicking more closely the structure and composition of human milk lipid droplets.
objectivesThis randomized, controlled, double-blind equivalence trial evaluates the safety and tolerance of a concept IMF with large, milk phospholipid-coated lipid droplets (mode diameter 3-5 μm) containing vegetable and dairy lipids in healthy, term infants.
methodsFully formula-fed infants were enrolled up to 35 d of age and randomly assigned to 1 of 2 formulas until 17 wk of age: 1) Control IMF with small lipid droplets containing vegetable oils (n = 108); or 2) Concept IMF with large, milk phospholipid-coated lipid droplets comprised of 48% dairy lipids (n = 115). A group of 88 breastfed infants served as reference. Primary outcome was daily weight gain during intervention. Additionally, number and type of adverse events, growth, and tolerance parameters were monitored.
resultsEquivalence of daily weight gain was demonstrated (Concept compared with Control IMF: -1.37 g/d; 90% CI: -2.71, -0.02; equivalence margin ± 3 g/d). No relevant group differences were observed in growth, tolerance and number, severity, or relatedness of adverse events. We did observe a higher prevalence of watery stools in the Concept than in the Control IMF group between 5 and 12 wk of age (P < 0.001), closer to the stool characteristics observed in the breastfed group.
conclusionsAn infant formula with large, milk phospholipid-coated lipid droplets containing dairy lipids is safe, well tolerated, and supports an adequate growth in healthy infants. This trial was registered in the Dutch Trial Register (www.trialregister.nl) as NTR3683.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.