Infant formula with dairy lipids showed no difference in fat mass compared to control formula or exclusive breastfeeding

BACKGROUND & AIMS: Childhood obesity is a global public health threat. Breastfeeding is associated with a protective effect on childhood overweight. Since breastfeeding is not always possible, infant formula (IF) should provide nutritional and functional properties as close as possible to human milk. We investigated body composition trajectories during the first 2 years of life of infants receiving until age 6 months Concept IF, containing large, phospholipid-coated lipid droplets enriched with dairy lipids, more closely mimicking human milk fat globule characteristics, in comparison with a conventional IF (Control) and exclusive breastfeeding (EBF). METHODS: In a randomized, controlled, double-blind trial, healthy term-born infants were assigned to receive Concept IF (n = 62) or Control IF (n = 64) until age 6 months. Infants receiving EBF for ≥6 months served as reference (n = 123). Body composition was measured by Air Displacement Plethysmography (ADP) until 6 months and by Dual-energy X-ray (DXA) from age 6 to 24 months. Ultrasonography measured abdominal subcutaneous and visceral fat thickness. Mixed models were used to evaluate body composition during the first 2 years of life, with fat mass index standard deviation score (SDS) from age 6-12 months as primary outcome. RESULTS: No differences were found between the Concept and Control group for fat mass index SDS and all other body composition trajectories. In comparison with the EBF group, both IF groups had more; visceral fat and a higher fat-free mass index SDS during the first 2 years of life and a lower fat mass percentage SDS and length SDS up to age 6 months. Concept IF was well-tolerated and had similar safety as Control IF based on adverse event outcomes. CONCLUSION: Body composition trajectories of infants receiving a Concept IF, containing large, milk phospholipid-coated lipid droplets enriched with dairy lipids, until the age of 6 months, were not; different from infants receiving Control IF during the first 2 years of life. As the first 6 months of life are; a critical window for adiposity programming which may only become evident later in life, more research is required to investigate potential long-term effects. CLINICAL TRIALS REGISTRATION NUMBER: not registered.