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Tracer kinetic studies on a methionine-supplemented soy-based infant formula using 1-13C- and 15N-methionine as tracers.

A tracer-kinetic study using 1-13C- and 15N-labeled L-methionine was conducted in order to measure the retention rate of free methionine added to commercially-produced soy-based infant formulas. Twelve male infants, fed on a soy formula, received a single-pulse labeling by oral administration of L-1-13C-methionine (5 mg/kg) and L-15N-methionine (10 mg/kg). The abundance of expired 13C-labeled CO2 was measured up to 7 h after administration at 15-, 30-, and 60-min intervals. Additionally, enrichment of total 15N and 15N in urinary ammonia were determined up to 48 h after administration. Retention rates of the labeled carboxyl group amounted to an average of 91.2% (SD 4.1) of the intake. A similar retention rate was measured for the 15N-label of methionine (90.0%, SD 4.3). The data point at the efficacy of methionine supplementation of soy-based infant formulas.

Ammonia↗

Infant formula record and record retention requirements--FDA. Final rule.

The Food and Drug Administration (FDA) is amending its infant formula regulations with respect to records, and retention of records, that relate to various subjects, including, but not limited to, microbiological and nutrient testing, manufacturers' audits, and consumer complaints. This action is in response to the 1986 infant formula amendments to the Federal Food, Drug, and Cosmetic Act (the act). The amended regulations will help ensure a safe, wholesale, and sanitary sole source of nutrition for infants.

Food Labeling↗

[Infant formulas based on dried milk and risks of its contamination with residual pesticides].

Residues of agricultural pesticides have the potential to enter the organism of farm animals and, subsequently, they can be transferred to milk. Infant formulas are manufactured from dried hydrolyzed cow's milk. Therefore, attention should be paid to possible contamination of the raw material for the manufacture of infant formulas with pesticide residues, especially those of persistent triazine herbicides. Dried milk based formulas are often the only food of young children in their first months of life. Thus, the control of infant milk formulas for pesticide residues is an important issue.

Animals↗

Hospital infant formula discharge packages. Do they affect the duration of breast-feeding?

OBJECTIVE: To determine whether the duration of breast-feeding is affected by the contents of the hospital discharge package. DESIGN: A randomized clinical trial with 2 experimental interventions (a discharge package containing a manual breast pump only and a discharge package containing a commercially prepared infant formula and a manual breast pump) and a control group who received a commercially prepared infant formula discharge package only. Sociodemographic characteristics and information concerning prior births (including feeding methods) were obtained from each mother within 48 hours of her infant's birth. Sources of influence on the mother's feeding decision, maternal attitudes concerning breast-feeding, and maternal feeding preferences were also assessed. PARTICIPANTS: The sample consisted of 763 women who had given birth who were admitted to the maternal-fetal unit of a midwestern community hospital. MAIN OUTCOME MEASURES: Information concerning current method of infant feeding was obtained from telephone interviews conducted at 2-week intervals until the infant was 16 weeks old. The data were analyzed using descriptive statistics, multivariate analysis of variance, logistic regression analysis, and survival analysis. RESULTS: The content of the hospital discharge package did not affect whether the mother engaged in exclusive or partial breast-feeding during the 16-week follow-up interval. However, there was some evidence that providing formula samples at discharge from the hospital increased the duration of exclusive breast-feeding compared with providing a manual breast pump. CONCLUSION: This study does not support the assumption that inclusion of infant formula in hospital discharge packages decreases the duration of breast-feeding.

Adult↗

Protein and lipid composition of human milk and infant formulas: comparison and nutritional consequences.

This work results from some research carried out by the authors during the last few years in nutrition field. The data collected allowed to compare protein and lipid composition of infant formulas with human milk and to evaluate the influence of such feedings on plasma aminoacid levels and erythrocyte fatty acids. In spite of different infant formula compositions with respect to human milk, our nutritional studies did not demonstrate physiological differences between breast and bottle-fed infants if formulas provide with an adequate intake of protein and linoleic acid.

Amino Acids↗

Determination of isoflavones in ready-to-feed soy-based infant formula.

An alkaline hydrolysis/liquid chromatography (LC) method was developed for determination of isoflavones in ready-to-feed soy-based infant formula. The method consists of a 15 min methanol extraction, 10 min alkaline hydrolysis, HCl neutralization, gravity filtration, aqueous dilution, and 50 min LC analysis with UV detection at 262 and 250 nm to quantify 6 isoflavone analytes: daidzin, glycitin, genistin, daidzein, glycitein, and genistein. The concentration averages for 10 commercial batches (microg aglycone/g formula) were daidzein, 6.12 +/- 1.23; glycitein, 1.19 +/- 0.16; genistein, 12.8 +/- 2.35; and total, 20.1 +/- 3.61. Validation experiments demonstrated extraction completion and analyte stability to alkaline hydrolysis. Spike recoveries ranged from 97.6 to 104.1%, and a series of accuracy assessments showed that isoflavone concentration determined by the method was within 5% of the true value. The relative standard deviation values for repeatability ranged from 0.4 to 2.2% (n = 10), and from 0.3 to 2.7% (n = 4) for intermediate precision. Isoflavone peak purity was verified by comparing sample and standard peak area ratios (262/250 nm). The limits of detection and quantitation (microg/ formula) ranged from 0.02 to 0.05 and 0.08 to 0.18 microg/g, respectively. The difference between our concentrations and those reported by others in 1995-1998 is attributable to the well-established seasonal variation in soybean isoflavone levels. Although the method was applied exclusively to ready-to-feed formula in the present study, it is equally suitable for powder and concentrated liquid infant formulas.

Chromatography, Liquid↗

Sterilization of infant formula.

A survey of 237 pediatricians currently practicing in Connecticut revealed that 97 (41%) recommend routine sterilization of infant formula for a mean of 4.4 months. Eight bottles of proprietary formula were prepared in a controlled manner: four utilizing the "terminal heating method" of sterilization and four utilizing the "clean method" without sterilization. While the "terminal heating method" resulted in less bacterial contamination, three of the bottles prepared by the "clean method" had negative coliform counts and the other bottle had a minimal count. Ten bottles prepared without sterilization were randomly selected from mothers who had brought their infants for well-child care. With the exception of a small inoculum of enterotoxin-producing Staphylococcus aureus in one bottle, no enteropathogens were identified. The implications of this study for the routine preparation of infant formula are discussed.

Food Handling↗

Estimation of the fluoride concentrations in human breast milk, cow's milk and infant formulae.

Fluoride has a significant effect on the prevention of dental caries. The major dietary intake of the infants constitutes the breast milk cow's milk and infant milk formulations in which the fluoride contents varies widely. Hence it is important to identify the potential milk source of high fluoride intake in an infant's diet and to evaluate the need for the fluoride supplementation. The aim of the present study was to determine the fluoride concentrations in breast milk, cow's milk, infant formulae and water samples in Mangalore city, India, using fluoride electrode (Orion Model 940900). It was noted that minimal amount of fluoride was found to be present in breast milk and cow's milk samples, while the fluoride content of water samples was found to be below the optimum level. On the contrary the infant formulae were found to have equal or more levels of fluoride.

Animals↗

[Past and present status in the design of infant formulas].

This paper describes briefly the history of infant foods, from the alternate ways of feeding developed during the late 19th century to the present-day infant formulas, and enumerates the different available types (milk-based, soy-based, hypoallergenic, lactose-free, etc,). Among the nutritional aspects the main characteristics of formulation are emphasized, especially within the nitrogen, fat and mineral fractions. Considering the nitrogen fraction, it must be taken into account that the amino acid profiles in milk-based formulas differ according to the casein/whey proteins ratio (either 80:20 or 40:60 in the so-called "adapted" or "humanized"). On the other hand, it has been recognized recently that some non-protein components of human milk, such as taurine, carnitine and nucleotides, are relevant to infant nutrition and therefore, they are being included in some formulas. Regarding fat, essential fatty acids supply is very important; present recommendations stress the importance of providing n-6 to n-3 series ratios close to that found in human milk and also a preformed supply of long-chain polyunsaturated fatty acids. Among minerals, bioavailability and relative proportions of trace elements are important issues in formulation. Other concepts of relevance are the renal solute load and the osmolarity because of their effect on neonate's metabolism.

Bottle Feeding↗

Lower calcium absorption in infants fed casein hydrolysate- and soy protein-based infant formulas containing palm olein versus formulas without palm olein.

OBJECTIVE: Quantitative balance studies were performed to compare fat and calcium absorption in healthy, full term infants fed casein hydrolysate-based (CHF) and soy protein-based (SPF) infant formulas with or without palm olein (PO). Previous studies have reported that PO significantly reduced absorption of both fat and calcium in cow's milk-based formulas in which most of the calcium is inherent in the milk protein. In both SPF and CHF virtually all calcium is added as calcium salts. METHODS: Two randomized, blinded, crossover balance studies were conducted in normal term infants using a three-day home balance method. One study evaluated 10 infants fed commercially available CHF with or without PO, and the other study evaluated 12 infants fed commercially available SPF with or without PO. Fat and calcium absorption were determined based on the weight of formula intake, weight of stools, and measured calcium and fat in formula and stools. RESULTS: Fat and calcium intake did not differ between the groups fed CHF. However, infant's calcium and fat absorption was less, 41 +/- 6% (Mean +/- SEM) and 92.0 +/- 0.8%, respectively, when fed CHF with PO compared to 66 +/- 5% and 96.6 +/- 1.1%, respectively, when fed CHF without PO, (p < 0.01). For infants fed SPF, fat and calcium intake did not differ between the feeding groups. Mean calcium absorption was also significantly less when infants were fed SPF with PO, 22 +/- 3%, than when fed SPF with no PO, 37 +/- 4% (p < 0.05). Fat absorption did not differ between the two SPFs. CONCLUSION: This study demonstrates that PO, as the predominant fat, is associated with significantly lower absorption of calcium from infant formulas in which calcium salts are the source of calcium. These findings corroborate previous reports of this negative effect of PO in cow milk-based infant formulas in which most of the calcium is a component of the cow milk protein source.

Calcium↗

Determination of lipids in infant formula powder by direct extraction methylation of lipids and fatty acid methyl esters (FAME) analysis by gas chromatography.

Fatty acid methyl esters (FAMEs) of pure triglyceride standards, oils, and fat from dry matrixes were formed by transesterification using sodium methoxide in methanol-hexane. FAMEs were produced by direct addition of sodium methoxide-hexane to samples and heating to simultaneously extract and transesterify acyl lipids. FAMEs were quantitated by capillary gas chromatography (GC) over a fatty acid concentration range of 0 to 1.7 mg/mL (r > or = 0.9997). Total fat was calculated as the sum of individual fatty acids expressed as triglyceride equivalents, in accordance with nutrition labeling guidelines. Saturated, polyunsaturated, and monounsaturated fats were calculated as sums of individual free fatty acids. Absolute recoveries determined from individual fatty acids in test samples ranged from 69.7 to 106%. Recoveries (relative to the C13:0 internal standard) for individual fatty acids in test samples ranged from 95 to 106%. Reproducibility was constant at each fatty acid level in the reaction mixture (n = 5, coefficient of variation [CV] < 2%). Absolute recovery determined from the sum of total fatty acids in standard reference material (SRM) 1846 (powdered infant formula) was 96.4%. Analysis of SRM 1846 gave results that agreed closely with the certified fat and fatty acid values. Analysis of commercial infant formula gave results that were comparable to those obtained with AOAC Method 996.01. The direct extraction methylation procedure is rapid, and the transesterification of acyl lipids to form FAMEs is complete within 15 min. Classical saponification and refluxing are not required. This method provides FAMEs free of interferences and easily quantitated by GC or confirmed by GC/mass spectrometry (MS). Unambiguous MS identification of individual FAMEs derived from pure standards, SRM 1846, and powdered infant formula product was obtained.

Chromatography, Gas↗

Concentrations of selected trace elements in human milk and in infant formulas determined by magnetic sector field inductively coupled plasma-mass spectrometry.

Magnetic sector field inductively coupled plasma-mass spectrometry (ICP-MS) was applied to the reliable determination of the 8 essential trace elements cobalt (Co), chromium (Cr), copper (Cu), iron (Fe), manganese (Mn), nickel (Ni), selenium (Se), and vanadium (V) as well as the 7 nonessential and toxic elements silver (Ag), aluminum (Al), arsenic (As), gold (Au), platinum (Pt), scandium (Sc), and titanum (Ti) in 27 transitory and mature human milk samples and in 4 selected infant formulas. This advanced instrumentation can separate spectral overlaps from the analyte signal hampering significantly the determination of many trace elements by conventional ICP-MS. Moreover, superior detection limits in the picogram per liter range can be obtained with such magnetic sector field instruments. Therefore, this is the first study to report, the concentrations of the elements Ag, Au, Pt, Sc, Ti, and V in human milk and in infant formulas. Concentrations of Ag (median: 0.41 microg/L; range: < 0.13-42 microg/L) and Au (median: 0.29 microg/L; range 0.10-2.06 microg/L) showed large variations in human milk that might be associated with dental fillings and jewelry. Pt concentrations were very low with most of the samples below the method detection limit of 0.01 microg/L. Human milk concentrations of Co (median: 0.19 microg/L), Fe (380 microg/L), Mn (6.3 microg/L), Ni (0.79 microg/L), and Se (17 microg/L) were at the low end of the corresponding reference ranges. Concentrations of Cr (24.3 microg/L) in human milk were five times higher than the high end of the reference range. For Al (67 microg/L), As (6.7 microg/L), and V (0.18 microg/L), most of the samples had concentrations well within the reference ranges. All elemental concentrations in infant formulas (except for Cr) were approximately one order of magnitude higher than in human milk.

Adult↗

In vitro dialyzability of zinc from different salts used in the supplementation of infant formulas.

Seven zinc salts--acetate, chloride, lactate, sulfate, citrate, gluconate, and oxide--were added to milk--and soy-based infant formulas to estimate possible differences in zinc availability depending on the type of salt used. For this purpose, an in vitro method that estimates the dialyzability of the element (i.e., the fraction available for absorption) was applied. Zinc dialyzability is always higher in milk-based products than in soy products, even when the total zinc contents are higher in the latter. The salts can be classified according to the zinc dialyzability in the two types of formulas as follows: oxide > gluconate = chloride = lactate > citrate = acetate > sulfate. Therefore, according to the dialysis percentage, oxide and gluconate are the compounds of choice for zinc supplementation of infant formulas.

Animals↗

Calcium retention from milk-based infant formulas, whey-hydrolysate formula, and human milk in weanling rhesus monkeys.

An adequate supply of calcium is important for normal bone mineralization in infants. Special infant formulas have been developed to treat infants with a high risk of developing allergy. Similar to other diets, it is important that these products are nutritionally adequate. We have measured calcium retention from a new formula based on whey hydrolysate and compared it with conventional formulas, using extrinsic labeling with calcium 47 and the weanling rhesus monkey as an animal model. Retention of calcium was similar for all formulas studied: 45% +/- 4% (mean +/- SEM) from whey-hydrolysate, 47% +/- 2% from whey-predominant, and 53% +/- 7% from casein-predominant formula. Calcium retention from human milk, 72% +/- 3%, was significantly higher than from formula. Using these retention values and the calcium concentrations of the diets, infant formula and human milk deliver approximately equal amounts of calcium to the infant.

Animals↗

Changing partners: the dance of infant formula changes.

The purpose of the study was to establish the frequency of, reasons for, and outcome of formula changes in infants. In this survey, we interviewed a convenience sample of 100 parents in our pediatric outpatient clinic and 75 parents in private pediatric office practices regarding their baby's initial formula, changes in formula, age at change, reason for change, initiator of the change, and outcome. The infants were 30-210 days old. Sixteen of the 175 infants (9%) were started on nonstandard formulas at birth. Fifty-eight of the remaining 159 infants (36%) were changed from regular to nonstandard formulas. After using nonstandard formulas, only seven infants (4%) were ever challenged subsequently with regular formula and all did well. Colic and regurgitation were the main reasons for switching formulas. In 47% the decision to change the formula was made by the mother and in 44% by the pediatrician. Following the formula change, mothers reported improvement or complete resolution of symptoms in 80% of infants. Although published estimates of formula intolerance range from 2% to 7.5%, one in three infants experiences a formula change, suggesting that nonstandard formulas are used excessively by both mothers and physicians. Nevertheless, in the vast majority of cases, parents report that the changes result in improvement or resolution of symptoms. Thus, while this practice appears to be a simple and effective intervention, it produces a significant population of soy and other nonstandard formula-fed babies who should be drinking regular formulas. Such changes encourage a belief by parents that their infants are allergic or otherwise abnormal and could have a negative impact on subsequent child development.

Humans↗

Detection by competitive enzyme-linked immunosorbent assay of a bovine serum albumin peptide (ABBOS) in infant formulas based on hydrolyzed cow's milk protein.

OBJECTIVE: Our aim was to determine whether currently available products based on hydrolyzed milk protein and a small peptide (ABBOS) in bovine serum albumin (BSA) (positions 126-144) share common antigenic sites. The commercial products are primarily developed to reduce cow's milk protein-associated allergenicity, but whether they also could be used in intervention trials to elucidate the role of BSA in the etiology of IDDM is not known. RESEARCH DESIGN AND METHODS: A sensitive competitive enzyme-linked immunosorbent assay (ELISA) using a rabbit polyclonal antibody raised against the ABBOS peptide in BSA was developed. With this method, we determined cross-reactivity between the ABBOS peptide and commercially available products: four milk protein hydrolysates and eight infant formulas based on hydrolyzed milk protein. The products were further characterized by physicochemical techniques. RESULTS: Hydrolyzed milk protein products are found to inhibit competitively the binding of ABBOS peptide to antibody. The number of residual reactive sites varied considerably among products and was not strongly related to the degree of hydrolysis (DH) or the molecular mass distribution of the hydrolysates. CONCLUSIONS: The presence of possible immunoreactive peptides in infant formulas based on hydrolyzed cow's milk protein cannot be adequately predicted by the DH or molecular mass distribution of the hydrolysates. Its specific determination is needed to ensure infant formulas free of cross-reactive ABBOS antibody binding sites for use in ongoing and forthcoming intervention trials to elucidate the role of BSA as a possible environmental triggering agent of IDDM.

Amino Acid Sequence↗

Analysis of Norwegian milk and infant formulas for ochratoxin A.

Samples of organic cow's milk, conventional cow's milk, and cow's milk-based infant formulas were analysed for the occurrence of ochratoxin A by means of an HPLC method. The detection limit was 10 ng/l. Ochratoxin A was detected in 6 out of 40 conventional cow's milk samples (range 11-58 ng/l), and in 5 out of 47 organic milk samples (range 15-28 ng/l). No ochratoxin A was detected in any of the 20 infant formula samples. The ochratoxin A levels in cow's milk found in this investigation are sufficient to cause a higher intake of ochratoxin A than the suggested TDI of 5 ng/kg bw/day, e.g. in small children who consume large quantities of milk.

Animals↗

Nutritional balance studies: evaluation of a premature infant formula.

A 24 kcal/oz (81 kcal/100 ml) premature infant formula (Enfamil Premature Formula) with moderately high mineral content (117 mg Ca/100 ml and 58 mg P/100 ml) and a protein content of 3 g/100 kcal was evaluated in sixteen 3-day balance studies at 10 and 21 days of age in nine premature infants with birth weights from 1,200 to 1,400 g. Growth rates were similar to in utero rates, and the formula was well accepted and tolerated. Calcium retention (62.5%) was similar to in utero accretion, and phosphorus retention was only slightly lower. Nitrogen retention was high without the development of metabolic acidosis or abnormal serum urea nitrogen levels.

Calcium↗