Objective: To evaluate the efficacy and safety of an a-lactalbumin-enriched formula with a protein profile and total protein concentration closer to human milk (HM) and lower than conventional formulas. Subjects/methods: Two hundred and sixteen healthy, term infants, p14 days post-natal age were enrolled and 166 (76.9%) completed the study. Timed post-prandial plasma essential amino-acid levels were determined after 8 weeks of ad libitum study feeding. Study events were assessed every 2 weeks. Results: At 8 weeks, all mean plasma essential amino-acid levels in the experimental formula (EF) group were as high as the standard formula (SF) and HM groups. The incidence of feeding-related gastrointestinal (GI) events varied significantly (P ¼ 0.025) across groups: SF (31.3%), EF (17.2%) and HM (13.6%), with SF being significantly higher than HM (P ¼ 0.015). Study withdrawals due to feeding-related GI events were significantly different (P ¼ 0.001) across groups: SF (12.5%), EF (4.7%), and HM (0%). The timing of GI events was also significantly different across groups (P ¼ 0.010). Conclusion: The study demonstrated that feeding a higher quality, lower protein concentration formula (a-lactalbuminenriched) met all essential amino acid and protein requirements of infants. The GI tolerance profile of infants receiving the EF was similar to HM-fed infants.

Background/Objectives:Protein concentration is lower in human milk (HM) than in infant formula. The objective of this study was to evaluate the effect of an α-lactalbumin-enriched formula with a lower protein concentration on infant growth, protein markers and biochemistries.Subjects/Methods:Healthy term formula-fed (FF) infants 5–14 days old were randomized in this controlled, double-blind trial to standard formula (SF: 14.1 g/l protein, 662 kcal/l) group (n=112) or experimental formula (EF: 12.8 g/l protein, 662 kcal/l) group (n=112) for 120 days; a HM reference group (n=112) was included. Primary outcome was weight gain (g/day) from D0 to D120. Secondary outcomes included serum albumin, plasma amino acids insulin and incidence of study events. Anthropometric measures were expressed as Z-scores using 2006 World Health Organization growth standards.Results:A total of 321 of the 336 infants (96%) who enrolled, completed the study. Mean age was 9.6 (±2.9) days; 50% were girls. Mean weight gain (g/day) did not significantly differ between SF vs EF (P=0.67) nor between EF vs HM (P=0.11); however weight gain (g/day) was significantly greater in the SF vs HM group (P=0.04). At day 120, mean weight-for-age Z-score (WAZ) and weight-for-length Z-score (WLZ) did not significantly differ between SF vs EF nor EF vs HM; however the WAZ was significantly greater in SF vs HM (P=0.025). Secondary outcomes were within normal ranges for all groups. Incidence of study events did not differ among groups.Conclusions:α-Lactalbumin-enriched formula containing12.8 g/l protein was safe and supported age-appropriate growth; weight gain with EF was intermediate between SF and HM groups and resulted in growth similar to HM-fed infants in terms of weight gain, WAZ and WLZ.

Background/ObjectivesBreast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification.Subjects/MethodsThis 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two (232) infants ≤ 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16.ResultsInfants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar.ConclusionsInfants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula.

To provide insight into polyaspartic acid nephroprotection and differences in aminoglycoside renal toxicity between two rat strains, the single-dose pharmacokinetics of tobramycin was examined in the presence and absence of polyaspartic acid. Following a single subcutaneous 6.5-mg/kg dose of tobramycin alone, higher aminoglycoside concentrations were measured in Sprague-Dawley rats than in Fischer rats (P < 0.05). Simultaneous administration of polyaspartic acid (50 mg/kg) and tobramycin did not alter the concentrations of tobramycin in serum. The amount of tobramycin in renal tissue and the amount recovered in urine over a 24-h period were greater in both rat strains when tobramycin and polyaspartic acid were given concomitantly. Rats from each strain were randomly assigned to treatment groups in either part 1 or 2 of the experiment. Part 1 addressed serum pharmacokinetics and consisted of 24 rats of each strain that received a single 6.5-mg/kg subcutaneous dose of tobramycin dissolved in sterile water for injection (sterile tobramycin sulfate; kindly donated by Eli Lilly & Co., Indianapolis, Ind.). A low dose of tobramycin was selected to avoid any complicating effect of Ag-induced renal dysfunction on the pharmacokinetics. An additional 24 rats of each strain received the same dose of tobramycin plus 50 mg of PAA (poly-L-aspartic acid, Na salt; molecular weight, 9,600-13,000; Sigma Chemical Co., St. Louis, Mo.) per kg dissolved in sterile water for injection. The PAA was injected subcutaneously at a site distant from the tobramycin immediately after the tobramycin injection. Serum was collected from three rats of each strain and each treatment group at 0, 15, 30, 45, 60, 120, 180, and 240

Lutein is a naturally occurring carotenoid in breast milk that has recently been added to infant formula. Lutein has a unique localization in the eye, where it functions by protecting the eye from oxidative and light‐induced damage. As humans cannot synthesize lutein, diet or supplements are the sources of this nutrient. We have previously shown that addition of lutein to formula results in comparable growth in infants over a four‐month period. In the current work, the absorption of lutein from infant formula was assessed in two animal models, neonatal pigs and infant rhesus monkeys, and in human infants. For animal studies, two doses of lutein in formula were administered via orogastric tubing. Lutein was delivered at 1.66 mg lutein/kg body weight (bw) and at 332 mcg/kg bw (pigs) or 166 mcg/kg bw (monkeys). Blood, collected just prior to formula administration and at multiple times afterwards, was analyzed for lutein by HPLC. The time course of absorption was rapid and similar to other carotenoids. There was a dose‐dependent response in the maximal plasma lutein concentration and lutein AUC. In addition to these animal studies, the absorption of lutein was studied in infants receiving fortified formula for approximately 36 days. A linear relationship between added lutein and the resultant infant plasma levels was observed. Overall these data provide support that lutein is well absorbed from infant formula.