Tolerance and Efficacy of Infant Formula with High Sn-2 Palmitate in Formula-Fed Chinese Term Infants: an Open Label, Controlled Trial

Abstract

Objectives:We assessed the efficacy of high sn-2 palmitate infant formula as compared with breast-milk in healthy full-term Chinese infants.Methods: Seventy five term infants, aged 14 days or less, appropriate for gestational age (34 formula-fed and 41 breast-fed) were recruited to this openlabel controlled multi-center trial. Formula fed infants were assigned to receive a formula with high sn-2-palmitate (40% of the palmitic acid is esterified to the sn-2 position of the triglyceride).Results: Anthropometric measurements of growth were done at randomization, and at 6 and 12 weeks postnatal age. Three-day records were completed by parents on stool characteristics and infants' wellbeing; face-to-face interviews were conducted according to a structured questionnaire. At 6 and 12 weeks of age, all infants presented normal growth parameters. Hard stools were not reported in both groups; however, the FF infants had less stools per day and a lower stool consistency score. The formula fed infants cried longer compared to the breastfed infants. There were no significant differences between the two groups in adverse effects. Conclusions:The formula containing high sn-2 palmitate had similar effect to breastfeeding on body growth, prevention of hard stools, and maintaining wellbeing in Chinese term infants. However, compared with breastfed infants, the FF group stool in the early 3 months of life was less soft (ClinicalTrials.gov Identifier: NCT01157390). sn-2 palmitate, such as increasing beneficial gut flora [15,16] and reducing infant crying [17]. According to our knowledge, this is the first study examining an infant formula with milk fat, prebiotics and structured lipids. The aim of this study was to examine the effect of SN-2 palmitate infant formula in Chinese infants compared to breastfed infants. Keywords Materials and Methods Study design and participantsThe study was designed as a multi-center, open-label controlled, 12 weeks study. Healthy term infants, appropriate for gestation age (AGA) with normal birth weight (2500-4000 g) were eligible for the study. The recruitment process was carried out by qualified pediatricians in local hospitals or maternal and Child Health Care centers located in the districts of Guangzhou and Hengyang, China. The infants were screened, using a standardized structured questionnaire, and had a physical examination by a qualified medical team. Exclusion criteria included infants with a congenital abnormality, suspected chromosomal or metabolic disorder or infants receiving medications at the first week of life. Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants were also excluded. The recruitment of formula fed infants (FF group) followed a maternal unequivocal decision not to breastfeed; the recruitment of breastfed infants (BF group) followed a maternal commitment to breastfeeding for at least 12 weeks. In this open-label, controlled, multi-center trial, we used per-protocol analysis, exa...

Acceptability of “High sn-2” Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician: An Open-Label Pilot Study in the Gulf Cooperation Council (GCC) Countries

“…According to Carnielli et al [10], the sn-2 formula was associated with the highest fat absorption compared to other formulas. Interestingly, Zhong and his colleagues [33] showed that the high sn-2 formula had a similar effect to breastfeeding on body growth and prevention of hard stools. Béghin et al [25], reported that the sn-2 formula and standard formula had a comparable effect on the body mass; however, the sn-2 group was associated with increased bone mineral content.…”