Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial
Ita Litmanovitz1, Fabiana Bar-Yoseph, Yael Lifshitz
1Neonatal Department Meir Medical center, (Tchernichovsky 59), Kfar Saba (4428164), Israel. litmani@clalit.org.il.
Insights
High beta-palmitate infant formula reduced crying duration and frequency in infants, mimicking breast milk benefits. This formula improved infant well-being and parental satisfaction during early life.
Area of Science:
- Pediatrics
- Infant Nutrition
- Gastroenterology
Background:
- Beta-palmitate (sn-2 palmitate) in infant formula aims to mimic human milk fat for easier digestion.
- A study hypothesized that high beta-palmitate formula would lead to softer stools and less crying in infants.
Purpose of the Study:
- To evaluate the effect of high beta-palmitate (HBP) formula on infant stool characteristics and crying patterns.
- To compare HBP formula with standard low beta-palmitate (LBP) formula and breast milk.
Main Methods:
- Randomized controlled trial involving formula-fed infants assigned to HBP or LBP formula.
- A matched group of breastfed infants (BF) served as a reference.
- Parents recorded crying and stool data for 3 days before 6- and 12-week visits.
Main Results:
- No significant differences in stool frequency or consistency were observed between the HBP and LBP groups.
- Infants in the LBP group cried more frequently during evenings (6 weeks) and afternoons (12 weeks) compared to HBP and BF groups.
- HBP formula significantly reduced crying duration compared to LBP formula (14.90 ± 3.85 vs. 63.96 ± 21.76 min/day).
Conclusions:
- High beta-palmitate formula consumption positively affects infant crying patterns in early life.
- HBP formula reduced crying duration and frequency, comparable to breastfeeding.
- This suggests improved infant well-being and parental satisfaction with HBP formula.
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.
