This study investigated growth, safety, and tolerance in healthy infants consuming a partly fermented infant formula (IF) with postbiotics, 2′-linked fucosyllactose (2′-FL), a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS), and milk fat. This double-blind, controlled trial randomised 215 fully IF-fed infants ≤ 14 days of age to either: Test Group (IF) containing 26% fermented formula with postbiotics derived from Lactofidus fermentation process (including 3′-Galactosyllactose; 3′-GL), 0.8 g/100 mL scGOS/lcFOS (9:1), 0.1 g/100 mL 2′-FL, and milk fat), or Control group (IF with 0.8 g/100 mL scGOS/lcFOS (9:1)) until 17 weeks of age. Fully breastfed infants were included as a reference. Anthropometric measures, gastrointestinal symptoms, and safety were assessed monthly. Equivalence in weight gain (primary outcome) between the Test and Control groups was confirmed (difference in means −0.08 g/day; 90% CI (−1.47;1.31)) with estimated mean weight gain (SE) of 31.00 (0.59) g/day and 31.08 (0.60) g/day, respectively, (PP population, n = 196). Equivalence in length and head circumference gain between the randomised groups was also confirmed. No statistically significant differences were observed in adverse events or gastrointestinal tolerance between randomised IF groups. A partly fermented IF with postbiotics, specific oligosaccharides, 2′-FL, and milk fat supports adequate infant growth and is safe and well-tolerated in healthy term infants.

Lipid 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. This 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. Fully 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. Equivalence 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. An 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.

Background: There are only a few small studies that compare breastfeeding rates in mothers with and without type 1 diabetes (T1D). Study design: We studied breastfeeding duration in 665 German infants whose mother and/or father had T1D from the BABYDIAB Study (data collected between 1992 and 2000) and compared it with data from 268 German infants of unaffected parents from the DONALD Study. Results: Infants with a parent who had T1D were less likely to be breastfed and breastfed for shorter lengths of time than infants from unaffected families. Mothers with T1D showed a positive long-term breastfeeding time trend, but did not reach the rates of the DONALD Study. Conclusions: This study identified minor secular trends influencing the differences in breastfeeding initiation and duration between families affected with T1D and those without.

Objective: To test equations for calculating infants’ energy requirements as a simple and reliable instrument for estimating the amount of breast milk consumed in epidemiological studies where test-weighing is not possible.Design: Infants’ energy requirements were calculated using three different equations based on reference data and compared with actual energy intakes assessed using the 3 d weighed dietary records of breast-fed infants from the DOrtmund Nutritional and Anthropometric Longitudinally Designed (DONALD) Study.Setting: A sub-sample of 323 infants from the German DONALD Study who were predominantly breast-fed for at least the first four months of life, and who had 3 d weighed dietary records and repeated body weight measurements within the first year of life.Subjects: Healthy, term infants breast-fed for at least 4 months, 0–12 months of age.Results: The overall differences between measured energy intake and calculated energy requirements were quite small, never more than 10 % of total energy intake, and smaller than the mean variance of energy intake between the three days of recording. The equation of best fit incorporated body weight and recent growth, while the worst fit was found for the equation not considering body weight.Conclusions: Breast milk consumption in fully and partially breast-fed infants can be reasonably quantified by calculating the infants’ individual energy requirements via simple equations. This provides a feasible approach for estimating infant energy intake in epidemiological studies where test-weighing of breast milk is not possible.