Tolerance, Bone Mineral Content, and Serum Vitamin D Concentration of Term Infants Fed Partially Hydrolyzed Whey-based Infant Formula

Abstract

Abstract:The objective of the study was to assess the tolerance (intake, incidence of spit up/vomit, and stool patterns), bone mineral status, and vitamin D status of healthy, term infants fed one of two partially hydrolyzed bovine whey protein infant formulas from birth to 56 or 84 days of age. The control formula was commercially available and was compared to an experimental formula.Eighty-nine term infants were enrolled in the study and 74 (83%) completed the study. The control formula had similar vitamin D but lower calcium and phosphorus content and contained palm olein oil and lactose compared to the experimental formula. Infants fed the experimental formula exhibited significantly greater serum 25-OH vitamin D levels at 2 months of age, significantly greater bone mineral content as assessed by dual-energy x-ray absorptiometry at 3 months of age and softer stools during the study period compared to infants fed the control formula. No differences were observed between groups for formula intake, incidence of spit up/vomit, anthropometric measurements, or serum concentrations of calcium, phosphorus, skeletal alkaline phosphatase, or parathyroid hormone.The results suggest that both study formulas are safe but differ in the metabolic response of infants fed the formula. Bone mineral content in these infants reflected differences in levels of nutrients important to calcium between two formulas over the short-term. Long-term implications and clinical relevance of these findings are unknown and require further study. These results provide additional knowledge regarding the typical vitamin D status as assessed by serum 25-OH vitamin D of healthy term formula-fed infants.

A Pooled Analysis of Growth and Tolerance of Infants Exclusively Fed Partially Hydrolyzed Whey or Intact Protein-Based Infant Formulas

“…Greater formula intake over time was also observed in the PHF-W-fed girls. Subjects in the PHF-W group consumed an average of 25 ounces/day at 1 month up to an average of 32 ounces/day at 4 months of age which is comparable to another study of partially hydrolyzed whey-based formula in the US in which infants consumed 24 ounces/day at 28 days of age up to 29.5 ounces/day at 84 days [ 22 ]. Wu and colleagues examined infants who were randomized to receive an intact whey:casein formula (61:39) or a partially hydrolyzed whey:intact casein (63:37) formula, and similarly saw greater formula intake in the group receiving partially hydrolyzed whey though no differences were observed in growth or stool consistency [ 23 ].…”

Calcium and fat metabolic balance, and gastrointestinal tolerance in term infants fed milk-based formulas with and without palm olein and palm kernel oils: a randomized blinded crossover study

“…Calcium retention and bone mineral content are better markers or functional outcomes for the impact of dietary calcium on calcium homeostasis compared to calcium absorption [ 29 ]. A recently published study [ 30 ] demonstrated a significantly (p = 0.041) lower bone mineral content at 3 months of age in term infants fed a POL containing partially hydrolyzed whey protein-based formula compared to a similar formula containing no POL. The fat blends of formulas compared in that study were similar to the PALM and NoPALM formulas assessed in our current study except for the inclusion of PKO and canola in the PALM formula of our current study.…”

Impact of palm olein in infant formulas on stool consistency and frequency: a meta-analysis of randomized clinical trials

“…Several clinical studies [ 5 – 12 ] have demonstrated the impact of the PALM predominant formulas on one or more of the three major physiological outcomes in infants. These outcomes were (a) reduced calcium and fat absorption or retention [ 5 – 7 , 9 , 14 ], (b) reduced bone mineral content or bone mineral density [ 11 – 16 ] and (c) harder stool consistency [ 7 – 12 ], which were observed in infants fed PALM formulas compared to those fed PALM-free formulas. The PALM formulas used in these studies were typically high in PA, which are low in sn-2 PAs ( Table 1 ).…”

“…Yu et al [ 21 ] reported that infants fed BetaPALM had softer stools compared to infants fed PALM, but reported no data on the comparison with PALM-free formulas. Moreover, other studies [ 9 – 11 ] have been published after the meta-analysis reports by Koo et al [ 14 ] in 2006 and by Yu et al [ 21 ] in 2009. The objective of the current study was to conduct a meta-analysis of up-to-date published randomized clinical trials (RCTs) comparing the effect of PALM-based formulas versus NoPALM-based formulas on stool consistency and frequency in healthy infants.…”