Multi-nutrient fortified formula improved processing speed in healthy children aged 3-6 years compared to control milk.
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Key Takeaway
Consider that multi-nutrient fortified formula improved processing speed but not full-scale intelligence in healthy children aged 3-6 years.
This cluster-randomized, double-blind, controlled trial evaluated the effects of a multi-nutrient fortified formula versus standard control milk in 120 healthy children aged 3 to 6 years. The study was conducted across four kindergarten classes with a follow-up period of 9.0 months. Safety parameters and growth were monitored throughout the intervention period.
The primary outcome, Full Scale Intelligence Quotient (WPPSI-IV), showed no significant difference between groups, with an adjusted mean difference of 1.05 points (95% CI: -1.42, 3.52; p = 0.400). However, the Processing Speed Index demonstrated a significant improvement in the intervention group, with an adjusted mean difference of 5.91 points (95% CI: 1.88, 9.93; p = 0.004).
Secondary outcomes indicated increased gut microbial alpha diversity (Shannon index) and gut microbial abundance, alongside elevated fecal 2-hydroxybutyric acid (2-HB). A positive association was observed between increases in alpha diversity and 2-HB with improvements in the Processing Speed Index (both p < 0.05). Specific effect sizes for these secondary outcomes were not reported.
Tolerability was excellent, as all children maintained normal growth and safety parameters, with no reported adverse events, serious adverse events, or discontinuations. Limitations regarding causality and funding were not reported in the provided data. The clinical relevance of these specific gut microbial changes on cognitive processing in this age group requires further investigation.
View Original Abstract ↓
BACKGROUND/OBJECTIVES: The preschool period is critical for neurodevelopment, yet evidence investigating fortified formula's effect and potential microbiota-gut-brain axis mechanisms in this age group is limited. To evaluate fortified formula milk's effect on neurodevelopment and explore potential microbiota-gut-brain axis mechanisms in preschool children.
METHODS: In this 9-month cluster-randomized, double-blind, controlled trial, 120 healthy children aged 3-6 years from four kindergarten classes were stratified by grade and randomly allocated (1:1) to receive either multi-nutrient fortified formula (intervention, = 60) or standard control milk ( = 60). Neurocognitive function was assessed using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV). Safety was evaluated through anthropometry and blood biochemistry. Gut microbiota (16S rRNA sequencing) and fecal metabolomes (untargeted LC-MS) were analyzed at baseline and 9 months.
RESULTS: The intention-to-treat (ITT) analysis showed no significant difference in Full Scale Intelligence Quotient (adjusted mean difference: 1.05 points; 95% CI: -1.42, 3.52; = 0.400). However, the intervention group significantly improved the Processing Speed Index (adjusted mean difference: 5.91 points; 95% CI: 1.88, 9.93; = 0.004), increased gut microbial alpha diversity (Shannon index) and abundance. Metabolomic analysis revealed elevated fecal 2-hydroxybutyric acid (2-HB), a marker of propanoate metabolism. Increases in both and 2-HB levels showed a positive association with PSI improvement (both < 0.05). All children maintained normal growth and safety parameters.
CONCLUSIONS: Fortified formula milk improved processing speed in preschoolers, a benefit associated with gut ecosystem modulation characterized by enrichment and upregulated microbial propanoate metabolism. These results offer preliminary evidence for the role of the microbiota-gut-brain axis in nutritional cognitive programming during early childhood. (Clinical Trial Registry: ChiCTR2400084211).
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