Background Palmitic acid (PA) is predominantly esterified at the SN-2 position of triacylglycerols in human milk. PA at the SN-2 position is more efficiently absorbed and results in reduced formation of PA soaps, as well as reduced fatty acid (FA) and calcium malabsorption. Bovine milk fat (MF), a natural source of SN-2-palmitate, was used in the fat blend of infant formulae (IF) in the current study to investigate its effect on stool fatty acid soaps, calcium excretion and stool characteristics. Methods Two double-blind, randomised cross-over trials (CS1, CS2) were conducted in parallel with healthy term, formula-fed infants aged 9–14 weeks. After a two-week run-in period, infants in CS1 (n = 17) were randomly allocated to receive either a 50% MF-based formula (50MF) or a 100% vegetable fat (VF) formula; in CS2 (n = 18), infants received either a 20% MF-based formula (20MF) or the VF formula, in a 2 × 2-week cross-over design. At the end of each two-week intervention period, stool samples were collected for FA, FA soaps and calcium excretion analysis and stool consistency was assessed according to the Amsterdam Infant Stool Scale (AISS). Results MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight, p < 0.0001; CS2: 216.24 ± 25.16 vs. 233.94 ± 35.12 mg/g dry weight, p = 0.0023), total FA soaps and calcium excretion (CS1: 46.40 ± 5.27 vs. 49.88 ± 4.77 mg/g dry weight, p = 0.0041; CS2: 46.20 ± 4.26 vs. 50.47 ± 6.71 mg/g dry weight, p = 0.0067) were observed. Furthermore, the 50MF group showed a favourable lower mean stool consistency score compared to the VF group (1.64 ± 0.49 vs. 2.03 ± 0.19, p = 0.0008). Conclusions While the use of bovine MF in IF did not affect PA concentrations in stool, lower excretion of palmitate soaps, total FA soaps and calcium was seen in healthy term infants. 50MF formula also showed improved stool consistency. The use of MF in IF could be an interesting approach to improve gut comfort and stool characteristics in infants, warranting further research. Trial registration Netherlands Trial Registry Identifier: NTR6702. Date registered: December 01, 2017.

BackgroundThe role of partially hydrolyzed formulas (pHF) as part of nutritional interventions to prevent the development of allergic manifestations (AM) is questioned, and efficacy of each specific pHF should be substantiated.ObjectiveTo investigate the risk-reduction effect of a whey-based pHF on the development of cow's milk protein allergy (CMPA) and atopic dermatitis (AD) in infants at high-risk for allergy within the first 6 months of life.Materials and MethodsIn a multicenter double-blinded randomized controlled setting, healthy non-exclusively breastfed full-term infants, received either a specific whey-based pHF or a standard cow's milk-based formula (SF) and were clinically assessed for AM at 2, 4, and 6 months of age, supported by the objective scoring tools SCORAD and CoMiSS. CMPA was confirmed by open food challenge. Intention-to-Treat (ITT) and Per-Protocol (PP) analyses were performed.ResultsOf 331 randomized subjects (ITT analysis set), 160 received the pHF and 171 the SF. Six (3.8%) infants in the pHF and 12 (7%) in the SF group developed CMPA (p = 0.186). AD incidence was significantly lower in those receiving pHF as compared to SF (10.6% vs. 18.7%, p = 0.024) with a relative risk (RR, 95% CI) of 0.54 (0.32, 0.92), in particular when adjusting for family history of AD [6.5% vs. 27.3%, RR 0.24 (0.07, 0.78), p = 0.018] representing a risk reduction of 76%. The PP analysis showed similar results.ConclusionThis specific whey-based pHF reduced the risk of AD development, particularly in those with a family history of AD, and tended to reduce the development of CMPA in non-exclusively breastfed infants at high-risk for allergy. The A.R.T. study suggests that this particular pHF may contribute to measures aimed at prevention of allergic manifestations. However, further studies are needed to confirm this risk-reduction effect.

The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55–80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of −3 g/day [mean difference (95% CI) test vs. control: −0.474 (−2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants’ weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.

AbstractIntroduction:Infant formula (IF) with vegetable fat blends typically have more than 80% of palmitic acid (PA) esterified at the sn-1 and sn-3 positions of triglycerides. Additional use of bovine milk fat (MF), a natural source of sn-2 palmitate, may enable increasing the sn-2 palmitate levels, potentially leading to improved absorption of fatty acids and calcium, and reduced formation of PA soaps associated with constipation in infants. The current study investigated the effect of IF with and without MF on the concentration of PA, PA soaps, calcium excretion and gastrointestinal tolerance using Amsterdam Infant Stool Scale (AISS) in healthy term infants.Materials and Methods:Two double-blind randomized placebo-controlled cross-over trials were conducted in parallel to compare a MF-based test formula with high sn-2 palmitate levels (39%) with a reference formula with only vegetable fat (10.1% sn-2 palmitate, cross-over study 1; CS1) and a MF-based test formula with medium sn-2 palmitate levels (19.7%) with the reference formula with only vegetable fat (cross-over study 2; CS2). CS1 included 17 and CS2 18 full-term, healthy, exclusively formula-fed infants screened between the 9th-14th week of age. After two weeks of wash-out period, in both CS1 and CS2, infants were randomized to receive either the MF-based test formula or reference. At the end of two weeks, the groups were crossed-over to receive the other formula for subsequent two weeks. Stool samples were collected after each two-week intervention period and bi-weekly diaries and questionnaires were completed by the parents/caretakers.Results:The PA concentrations in stools (mg/g dry weight) did not differ between the MF-based test and reference formula in either CS1 (p = 0.1324) or CS2 (p = 0.1198). A reduction was observed in the concentration of PA soaps in both medium and high sn-2 palmitate formula, with a more pronounced effect for the high sn-2 palmitate formula (medium; p = 0.0023 and high; p < 0.0001). In addition, calcium excretion in stools was significantly lower in the MF-based formula groups as compared to the reference in both studies (medium; p = 0.0067 and high; p = 0.0041). In CS2, stool consistency did not differ between groups whilst in CS1, a favorable effect of high sn-2 palmitate formula compared to the reference formula (p = 0.0008) was noted.Conclusion:Bovine milk fat in infant formula reduced the excretion of PA soaps and calcium in stool samples of healthy term infants. High sn-2 palmitate formula showed a more pronounced effect and improved stool consistency according to the AISS.

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