Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial

Béghin, Laurent; Marchandise, X.; Lien, Eric L.; Bricout, Myriam; Bernet, Jean-Paul; Lienhardt, Jean-François; F, Jeannerot; Menet, Vincent; Requillart, Jean-Christophe; Marx, Jacques; Groot, Nanda de; Jaeger, Jonathan; Steenhout, Philippe; Turck, Dominique

doi:10.1016/j.clnu.2018.05.015

Cited by 50 publications

(33 citation statements)

References 21 publications

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“…Our growth outcomes of infants fed the pHF are also similar to those of infants fed reduced intact protein formulae as investigated by Alexander et al [28] and Beghin et al [29]. Alexander et al [28] performed a pooled data analysis of 11 randomised controlled trials in healthy term infants fed whey-predominant formulae with a content of 1.8 g/100 kcal intact protein with or without additional ingredients (probiotics, prebiotics, or both).…”

Section: Discussionsupporting

confidence: 71%

“…The mean (SD) weight gain from inclusion to 4 months across the three groups was 27.8 (5.7) g/day ( n = 488), which is slightly lower to our observed data in the reduced protein groups: pHF1.8: 29.6 (5.8) and pHF2.0: 28.0 (4.4) g/day, and considerably lower than that observed in our pHF2.27 group with 31.0 (5.6) g/day. In summary, in contrast to older studies suggesting that the nutritional value of formulae containing hydrolysed protein could be lower than that containing intact protein [11], the growth parameters in our study of the two experimental and the control formulae are comparable to the reports of recent studies, evaluating growth in healthy term infants fed intact whey dominant formula with a protein content of 1.8 or 2.1 g/100 kcal [28,29].…”

Section: Discussionsupporting

confidence: 70%

“…Beghin et al [29] reported a large randomised controlled trial evaluating growth in term infants fed from ≤1 week to 4 months of age one of three identical whey-predominant formula containing 2.1 g/100 kcal protein but differing by their SN2–palmitate content. The mean (SD) weight gain from inclusion to 4 months across the three groups was 27.8 (5.7) g/day ( n = 488), which is slightly lower to our observed data in the reduced protein groups: pHF1.8: 29.6 (5.8) and pHF2.0: 28.0 (4.4) g/day, and considerably lower than that observed in our pHF2.27 group with 31.0 (5.6) g/day.…”

Section: Discussionmentioning

confidence: 99%

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Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

et al. 2019

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The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants. Fully formula-fed infants were randomised ≤14 days of age to receive a partially hydrolysed whey formula with 2.27 g protein/100 kcal (pHF2.27) or the same formula with 1.8 g or 2.0 g protein/100 kcal (pHF1.8 and pHF2.0) until 4 months of age. The primary outcome was equivalence in daily weight gain within margins of ± 3 g/day; comparison with WHO Child Growth Standards; gastrointestinal tolerance parameters and number of (serious) adverse events were secondary outcomes. A total of 207 infants were randomised, and 61 (pHF1.8), 46 (pHF2.0) and 48 (pHF2.27) infants completed the study per protocol. Equivalence in daily weight gain was demonstrated for the comparison of pHF1.8 and pHF2.27, i.e., the estimated difference was −1.12 g/day (90% CI: [−2.72; 0.47]) but was inconclusive for the comparisons of pHF2.0 and pHF2.27 with a difference of −2.52 g/day (90% CI: [−4.23; −0.81]). All groups showed adequate infant growth in comparison with the World Health Organization (WHO) Child Growth Standards. To conclude, the evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 99%

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Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

et al. 2019

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“…When human infant formula contains palmitic acid at the sn-2 position, improved absorption of fat and calcium with absorption rates similar to those seen in breastmilk-fed infants is observed [39]. Consequently, a low palmitic acid formula has been developed to reduce the amount of sn-1, 3 palmitic acids thus enabling higher absorption of calcium and fat in neonates [40,41].…”

Section: Saturated and Monounsaturated Fatty Acidsmentioning

confidence: 99%

Breast Milk Lipids and Fatty Acids in Regulating Neonatal Intestinal Development and Protecting against Intestinal Injury

et al. 2020

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Human breast milk is the optimal source of nutrition for infant growth and development. Breast milk fats and their downstream derivatives of fatty acids and fatty acid-derived terminal mediators not only provide an energy source but also are important regulators of development, immune function, and metabolism. The composition of the lipids and fatty acids determines the nutritional and physicochemical properties of human milk fat. Essential fatty acids, including long-chain polyunsaturated fatty acids (LCPUFAs) and specialized pro-resolving mediators, are critical for growth, organogenesis, and regulation of inflammation. Combined data including in vitro, in vivo, and human cohort studies support the beneficial effects of human breast milk in intestinal development and in reducing the risk of intestinal injury. Human milk has been shown to reduce the occurrence of necrotizing enterocolitis (NEC), a common gastrointestinal disease in preterm infants. Preterm infants fed human breast milk are less likely to develop NEC compared to preterm infants receiving infant formula. Intestinal development and its physiological functions are highly adaptive to changes in nutritional status influencing the susceptibility towards intestinal injury in response to pathological challenges. In this review, we focus on lipids and fatty acids present in breast milk and their impact on neonatal gut development and the risk of disease.

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“…Synthetic structured TAGs have been developed with higher proportion of PA in the SN-2 position (ranging from 35.9–74%) and lower levels of PA at the SN-1 and SN-3 positions. Favourable effects of IF containing such synthetic TAGs on FA, calcium absorption and stool consistency have been reported in healthy infants by several studies [ 6 , 7 , 13 – 19 ].…”

Section: Introductionmentioning

confidence: 96%

Effect of milk fat-based infant formulae on stool fatty acid soaps and calcium excretion in healthy term infants: two double-blind randomised cross-over trials

et al. 2020

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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.

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Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial

Abstract: Formulae enriched in sn-2 palmitate fed in early infancy are safe, improve stool consistency (from 2 weeks to 2 months) and increase bone mineral content (at 4 months).

Cited by 50 publications

References 21 publications

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

Breast Milk Lipids and Fatty Acids in Regulating Neonatal Intestinal Development and Protecting against Intestinal Injury

Effect of milk fat-based infant formulae on stool fatty acid soaps and calcium excretion in healthy term infants: two double-blind randomised cross-over trials

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