Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial

Ita Litmanovitz, Fabiana Bar-Yoseph, Yael Lifshitz, Keren Davidson, Alon Eliakim, Rivka H Regev, Dan Nemet, Ita Litmanovitz, Fabiana Bar-Yoseph, Yael Lifshitz, Keren Davidson, Alon Eliakim, Rivka H Regev, Dan Nemet

Abstract

Background: Beta-palmitate (sn-2 palmitate) mimics human milk fat, enabling easier digestion.Therefore, we hypothesized that infants consuming high beta-palmitate formula would have more frequent, softer stools and reduced crying compared to infants consuming low beta-palmitate formula.

Methods: Formula-fed infants were randomly assigned to receive either (1) formula with high beta-palmitate (HBP, n = 21) or (2) regular formula with a standard vegetable oil mix (LBP, n = 21). A matched group of breastfed infants served as a reference (BF, n = 21). Crying and stool characteristics data were recorded by the parents for 3 days before the 6- and 12-week visits.

Results: We found no significant differences in the stool frequency or consistency between the two formula groups. The percentage of crying infants in the LBP group was significantly higher than that in the HBP and BF groups during the evening at 6 weeks (88.2% vs. 56.3% and 55.6%, p < 0.05) and during the afternoon at 12 weeks (91.7% vs. 50.0% and 40%, p < 0.05). The infants fed HBP had significantly shorter crying durations when compared with infants fed LBP formula (14.90 ± 3.85 vs.63.96 ± 21.76 min/day, respectively; p = 0.047).

Conclusions: Our study indicates that consumption of a high beta-palmitate formula affects infant crying patterns during the first weeks of life. Comparable to breastfeeding, it reduced crying duration and frequency, primarily during the afternoon and evening hours, thereby improving the well-being of formula-fed infants and their parents.

Trial registration: NCT00874068.Registration date March 31, 2009.

Figures

Figure 1
Figure 1
Participant flow diagram.
Figure 2
Figure 2
Diurnal pattern of crying in LBP formula-fed, HBP formula-fed, and breastfed infants at 6 (Upper panel) and 12 (Lower panel) weeks postnatal.
Figure 3
Figure 3
Total daily crying in LBP formula-fed, HBP formula-fed, and breastfed infants at 12 weeks of age. Data are means ± standard error.

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