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Requirements for the safety and nutritional adequacy of infant formula are set by legislation and aim for the best possible substitute for human milk with regard to growth, development and biological effects. This is, however, a continuous process and has to be supported by science-driven innovative activities of manufacturers and be confirmed by adequate clinical studies performed according to agreed standards.
The molybdenum (Mo) levels in the plasma and urine of 30 premature and 15 full-term infants have been compared with the Mo intakes and urine uric acid excretion (uric acid/creatinine ratio) produced by the Mo enzyme xanthine oxidase. The Mo intakes of full-term infants were 41 +/- 14 nmol/kg/day (mean +/- SEM). In the premature group breast milk supplied significantly less Mo (4.3 +/- 0.4 nmol/kg/day) than infant formulas (101 +/- 31 nmol/kg/day) or premature formula (255 +/- 13 nmol/kg/day). When fed breast milk, the preterm infants displayed similar or higher plasma and urine Mo and urine uric acid levels than formula-fed infants. For the whole preterm group a significant correlation was determined for urine Mo levels and Mo intakes as well as for plasma Mo and uric acid excretion. The bioavailability of breast milk Mo seems to be higher than formula Mo according to the Mo levels and to their statistical link with uric acid excretion which could be proposed as a functional index of Mo status. These parameters displayed similar values in breast milk-fed prematures and control full-term infants. The Mo needs of formula-fed premature newborns remain to be defined using complete balance trials.
Selenium (Se) absorption was studied in human milk, bovine milk and infant formula (Similac) using suckling rats as a model. The effect of age on Se absorption from the three milk diets extrinsically labeled with 75Se, either as selenite or selenomethionine, was also investigated. Milk diets were fed by gastric intubation and the radioactivity in the carcass, gastrointestinal tract and the liver were measured 3 h after feeding. There was no difference in [75Se]selenite absorption from the three milk diets between 8-20 d of age. However, significantly higher quantity of 75Se was absorbed from all three milk diets by 20-d-old rats than by the younger rats (46 vs. 32%). This increase in [75Se]selenite absorption with advancing age is opposite to what has been found for most other trace elements. When rats were fed milk diets labeled with [75Se]selenomethionine, the absorption of 75Se was approximately twofold higher in all age groups compared with 75Se absorption from selenite. No difference in [75Se]selenomethionine absorption existed among the three milk diets in 8- or 10-d-old suckling rats. However, at 15 d of age [75Se]selenomethionine absorption from human milk was higher (82%) than from either bovine milk (72%) or infant formula (72%). Between 8 and 20 d of age, absorption of [75Se]selenomethionine from the three milk diets decreased with advancing age. Adding sodium selenate to increase the total nonradioactive Se of human milk, bovine milk (endogenous plus the added selenium) did not affect the absorption of either [75Se]selenomethionine or [75Se]selenite.
Nizatidine (Axid) is an H2-receptor antagonist used for the treatment of acid-related gastrointestinal disorders. Given the frequency of these conditions in children and the potential for pediatric use of nizatidine, an oral liquid dosage formulation would provide an alternative treatment option for patients unable to swallow solid oral dosage forms. This study was designed as an open-label, single-dose, four-way crossover trial to investigate the bioequivalence of 150 mg nizatidine administered in three oral liquid formulations (a commercially prepared oral syrup, an extemporaneous solution in apple juice, and an extemporaneous suspension in infant formula) relative to the marketed capsule formulation. Twenty-four adult subjects (ages 31.2 +/- 7.5 years; weight 71.1 +/- 11.8 kg) were enrolled, and blood samples for determination of plasma nizatidine concentrations were collected prior to drug administration and at 19 discrete intervals over a 24-hour postdose interval. Nizatidine was quantitated from plasma using a validated HPLC-MS assay, and a noncompartmental approach was used to describe nizatidine biodisposition in all subjects. Significant treatment effects were observed for log-normalized Cmax, AUC0-n, and AUC0-infinity (p < 0.001). Further evaluation revealed that nizatidine prepared in apple juice was markedly less bioavailable than the reference capsule, with 90% confidence intervals (CIs) of 0.518-0.626, 0.682-0.751, and 0.696-0.763 for Cmax, AUC0-n, and AUC0-infinity, respectively. The remaining two oral formulations demonstrated 90% CI within the guidelines established by the Food and Drug Administration (e.g., 0.80-1.25). Thus, nizatidine in infant formula and the commercially prepared oral syrup can be considered bioequivalent to the reference capsule.
The purpose of this case-control investigation was to investigate the possible association between mild-to-moderate enamel fluorosis and exposure during early childhood to fluoride supplements, fluoride toothpaste, and/or infant formula use in nonfluoridated communities. Analysis was performed on 460 10- to 13-year-old children, born after 1979, who were residents of six nonfluoridated communities in Massachusetts and Connecticut. The fluorosis status of the subjects was determined on the basis of a clinical dental examination using the Fluorosis Risk Index (FRI). Risk factor exposure was ascertained via a mailed questionnaire with a response rate of 90% and a questionnaire reliability of 87%. Logistic regression analyses revealed a moderate association between mild-to-moderate enamel fluorosis on early forming (FRI classification I) enamel surfaces and both fluoride supplement use (odds ratio (OR) = 2.25, 95% confidence interval (CI) 1.08-4.69) and early toothbrushing habits (OR = 2.56, 95% CI 1.34-4.88). There was a strong association between mild-to-moderate fluorosis on later forming (FRI classification II) enamel surfaces and both supplement use (OR = 7.97, 95% CI 2.98-21.33) and early toothbrushing habits (OR = 4.23, 95% CI 1.72-10.41). Infant formula was not found to be associated with fluorosis on either FRI classification I or II surfaces.
BACKGROUND: Weighing breastfed babies has been the subject of some controversy as the previous international growth chart was largely based on data from infants fed infant formula. The concern that professionals may be misled by the charts into suggesting to mothers that they supplement unnecessarily was a major impetus for the World Health Organization's investment in a new growth chart. Evidence of interpretation in practice has been scant. METHODS: An ethnographic study was conducted in a town in the Northwest of England to investigate this issue. In the first phase, women and health visitors were observed in the well-child clinic during clinic sessions and breastfeeding group meetings. In the second phase, longitudinal interviews with 14 women were conducted. Each woman was interviewed up to three times in the first six months after the birth of her baby, with a total of 35 interviews. RESULTS: Mothers and health visitors focussed on weight gain with frequent weighing and attention to even minor fluctuations of the plotted line being evident. Women felt it important to ensure their baby's weight followed a centile, and preferred for this to be the fiftieth centile. Interventions included giving infant formula and solids as well as changing what the mother ate and drank. Women also described how they worried about their baby's weight. Little effective support by health professionals with breastfeeding technique was observed. CONCLUSION: Babies were weighed more often than officially recommended, with weighing and plotting being at the core of each clinic visit. The plotted weight chart exerted a powerful influence on both women's and health visitors' understanding of the adequacy of breastfeeding. They appeared to rate the regular progression of weight gains along the chart centiles more highly than continued or exclusive breastfeeding. Thus weighing and visual charting of weight constituted a form of surveillance under the medical gaze, with mothers actively participating in self monitoring of their babies. Interventions, by mothers and health visitors, were targeted towards increasing weight gain rather than improving breastfeeding effectiveness. Improvements in training are needed for health visitors in weighing techniques, assessing growth patterns--particularly of breastfed babies--and in giving information to women, if the practice of routine weight monitoring is to support rather than undermine breastfeeding.
The presence of large amounts of probiotic bacteria in a sample may interfere with the detection of undesirable microorganisms. To illustrate this, infant formula with various strains of probiotic bacteria and the corresponding probiotic culture powders and premixes were artificially contaminated with low levels of Salmonella. Recovery of Salmonella was generally very poor when the conventional pre-enrichment procedure using buffered peptone water (BPW) was applied. However, this problem was overcome by adding antimicrobial compounds to selectively suppress the growth and/or metabolic activity of the probiotic bacteria and increasing the buffering capacity of the pre-enrichment broth. It is recommended that these analytical constraints are already addressed during the development phase of new probiotic products.
Production of new protein-based products for special nutrition such as hypoallergenic infant formulas, fortified beverages and nutraceutics, require ideal ingredients. Protein ingredients were developed by enzymatic hydrolysis and methionine synthesis of soy protein. Hydrolysis was done at 4% (w/v) using porcine pancreatic enzymes (4% w/w), 50 degrees C, 6 h and pH 8. After drying powder was resuspended (20% w/v) and incubated with 7.6% (w/w) methionine methyl-ester, 1% (w/w) chymotrypsin and 3 M glycerol, 37 degrees C, 3 h and pH 7. Hydrolysates were fractionated by ultrafiltration (UF) before and after enrichment (E): FI > 10, 10 > FII > 3 and 3 > FIII > 1 kDa. Functional properties, amino acid content, anti-physiological factor activities and antigenicity were assayed for all the UF fractions and the soybean meal. Protein quality bioassay and sensorial test of an non-enriched fraction and an enriched fraction were performed. Functional properties were positively modified by hydrolysis and synthesis by using a minimum time and methionine added for the last reaction. After UF all the fractions under 10 kDa showed 100% solubility (pH 4 and 7), good clarity, acceptable foam capacity and negligible antigenicity and antiphysiological activities. Additionally, methionine enrichment enhanced their nutritional value, upgrading sulfur amino acid requirements for infants and adults. Because functionality and nutritional value FIII-E could be used for hypoallergenic infant formulas, FII-E for fortified soluble formulas and nutraceutics and FI-E for a semi-solid baby food.
Long-chain polyunsaturated fatty acids (LC-PUFA) are important in the development of the immature nervous system, and adding these fatty acids to infant formula has been proposed. To determine the effect of n-3 LC-PUFA on apolipoprotein secretion and lipid synthesis in newborn swine enterocytes, differentiated IPEC-1 cells were incubated for 24 h with docosahexaenoic acid (DHA; 22:6) or eicosapentaenoic acid (EPA; 20:5) complexed with albumin at a fatty acid concentration of 0.8 mM or albumin alone (control) added to the apical medium. Oleic acid (OA; 18:1) was used a control for lipid-labeling studies. Both DHA and EPA reduced apolipoprotein (apo) B secretion by one-half, whereas EPA increased apo A-I secretion. The increased apo A-I secretion occurred primarily in the high-density lipoprotein fraction. These changes in apoprotein secretion were not accompanied by significant changes in synthesis. Modest decreases in apo B mRNA levels were observed for DHA and EPA, whereas there were no changes in apo A-I mRNA abundance. EPA reduced cellular triacylglycerol labeling by one-half, and DHA and EPA decreased cellular phospholipid labeling compared with OA. Labeled triacylglycerol secretion was decreased 75% by EPA, and DHA doubled labeled phospholipid secretion. If present in vivo, these effects should be considered before supplementing infant formula with these fatty acids.
Since the 1930s, plasticizers have been used to impart flexibility to an otherwise rigid polyvinylchloride (PVC). Di-(2-ethylhexyl)-phthalate (DEHP) is the most widely used plasticizer in PVC formulations. However, DEHP leaks out from PVC items with time and use and consequently it is an ubiquitous environmental contaminant. To date, very little is known about the actual extent of DEHP exposure in infants, who are believed to be the most sensitive population, as they may be exposed to several different sources (breast milk, infant formula, baby food, indoor air, and by dermal and oral exposure via indoor dust containing DEHP) since early in life and since differences in DEHP pharmacokinetics and metabolism between children and adults have been well documented. Little information exists on DEHP dietary exposure, believed to represent a major source and orally administered DEHP is converted more rapidly to MEHP than other routes of exposure. Although DEHP has been shown to induce toxicity in experimental animals, a limited but suggestive human exposure data causes a serious concern that an early in life DEHP exposure may adversely affect male reproductive tract development. Here, we report a review on dietary phthalate exposure in babies.
The content of folliculostimulating (FSH), luteinizing (LH), thyrotropic (TTH) hormones and prolactin was studied in the blood serum of pregnant women and puerperants; also the thyroxin (T4), triiodthyronin (T3), thyroxin-binding globulin (TBG) levels, and the thyroxin-binding capacity of proteins and free T4 index were determined in the blood serum and milk of puerperants during the first week of lactation. The blood serum FSH, LH, TTH and prolactin concentrations underwent definite changes connected with physiological reconstruction of the organism at these periods. The milk T4 and T3 levels showed a sharp elevation by the 6th day of lactation, this correlating with the changes in the blood serum. The milk TSH concentration was much lower than in the serum; the same regularity was revealed for the protein thyroxin-binding capacity. The free T4 index is exceedingly high in milk, being much greater than that in the blood serum. Of the 10 food products for supplementary feeding of children an insignificant amount of T4 was revealed in two only. No T4 was found in cow milk.
We developed a sensitive sandwich-type ELISA for measuring low levels of cow's milk (CM) beta-lactoglobulin. Purified anti-beta-lactoglobulin was used as coating antibody and also as second antibody conjugated with alkaline phosphatase. Polyethylene glycol 6000 was added to the incubation buffers to improve sensitivity. The detection limit of the assay was 0.002 microgram/l, which is much better than sensitivities reported for other beta-lactoglobulin assays. The sensitivity was not impaired by the presence of other CM proteins. The recovery from breast milk was 93% and from the diluting buffer 127%. The coefficient of variation within day was 5-15% and between days 10%. One hour after oral intake of milk, beta-lactoglobulin could be detected in the breast milk of three mothers at concentrations of about 1-2 micrograms/l. Widely different concentrations of beta-lactoglobulin were measured in two protein hydrolysates based on CM whey and casein proteins; the observed concentrations were 200 and 0.0056 micrograms beta-lactoglobulin/g dry weight, respectively.
A high-performance liquid chromatography (HPLC) method to determine available lysine is proposed. Available lysine was measured by an optimised fluorodinitrobenzene method on the basis of the reactivity of the free epsilon-amino group of the lysine. The classical acid hydrolysis has been improved and shortened from the usual time of 12 h to 2 h 30 min using an oil bath. Optimal resolution and quantitation of Nn-dinitrophenyllysine was obtained with a Nova-Pak C18 column using an isocratic elution with 35% methanol and 65% 0.01 M sodium acetate buffer (pH 4.5) and a flow-rate of 1 ml/min. Satisfactory results were obtained for the reliability of the method in terms of linearity from 0.1 to 5.0 mg/l of lysine-free base, precision (R.S.D. values between 4.3% and 7.8%), recovery (91.5%) and sensitivity (detection limit of 0.02 mg/l). The proposed method has also been checked for lack of interferences from other dinitrophenyl-amino acids.
OBJECTIVE: In high HIV prevalence resource-constrained settings, exclusive breastfeeding with early cessation is one of the conceivable interventions aimed at the prevention of HIV through breast milk. Nevertheless, this intervention has potential adverse effects, such as the inappropriateness of complementary feeding to take over breast milk. The purpose of our study first was to describe the nature and the ages of introduction of complementary feeding among early weaned breastfed infants up to their first birthday and second was to assess the nutritional adequacy of these complementary foods by creating a child feeding index and to investigate its association with child nutritional status. METHODS: A prospective cohort study in Abidjan, Côte d'Ivoire, was conducted in HIV-infected pregnant women who were willing to breastfeed and had received a perinatal antiretroviral prophylaxis. They were requested to practice exclusive breastfeeding and initiate early cessation of breastfeeding from the fourth month to reduce breast milk HIV transmission. Nature and ages of introductory complementary feeding were described in infants up to their first birthday by longitudinal compilation of 24-hour and 7-day recall histories. These recalls were done weekly until 6 weeks of age, monthly until 9 months of age, and then quarterly. We created an index to synthesize the nutritional adequacy of infant feeding practices (in terms of quality of the source of milk, dietary diversity, food, and meal frequencies) ranging from 0 to 12. The association of this feeding index with growth outcomes in children was investigated. RESULTS: Among the 262 breastfed children included, complete cessation of breastfeeding occurred in 77% by their first birthday, with a median duration of 4 months. Most of the complementary foods were introduced within the seventh month of life, except for infant food and infant formula that were introduced at age 4 months. The feeding index was relatively low (5 of 12) at age 6 months, mainly as a result of insufficient dietary diversity, but was improved in the next 6 months (8.5 of 12 at 12 months of age). Inadequate complementary feeding at age 6 months was associated with impaired growth during the next 12 months, with a 37% increased probability of stunting. CONCLUSION: Adequate feeding practices around the weaning period are crucial to achieving optimal child growth. HIV-infected women should turn to early cessation of breastfeeding only when they are counseled properly to provide adequate complementary feeding to take over breast milk. Our child feeding index could contribute to the assessment of the nutritional adequacy of complementary feeding around the weaning period and therefore help to detect children who are at risk for malnutrition.
BACKGROUND: In contrast to human milk, current infant formulas in the United States do not contain omega3 and omega6 long-chain polyunsaturated fatty acids. This may lead to suboptimal blood lipid fatty acid profiles and to a measurable diminution of visual function in developing term infants. The need for docosahexaenoic acid and arachidonic acid supplementation in the infant diet was evaluated in a double-blind, randomized clinical trial. METHODS: Healthy term infants were randomized to diets of (1) commercial formula, (2) docosahexaenoic acid-enriched formula (0.35% of total fatty acids), or (3) docosahexaenoic acid- (0.36%) and arachidonic acid- (0.72%) enriched formula. Eighty-seven infants completed the 17-week nutritional trial, and 58 were observed until 52 weeks of life. A reference group was exclusively breast fed for at least 17 weeks (n = 29). Outcome measures included electroretinographic responses, visual evoked potentials, and blood fatty acid analysis in infants at birth and at 6, 17, and 52 weeks of age. RESULTS: Commercial formula-fed infants had 30% to 50% lower content of docosahexaenoic acid in total red blood cell lipids during the 17-week feeding trial compared with breastfed infants. Significant differences persisted at the 1-year follow-up. Arachidonic acid content was consistently reduced in the commercial formula group by 15% to 20%. Infants fed long-chain polyunsaturated fatty acid-enriched formulas had docosahexaenoic acid and arachidonic acid blood lipid profiles resembling those of human milk-fed infants. Infants receiving this enriched formula had more mature electroretinographic responses than commercial formula-fed infants at 6 weeks of age. Human milk-fed and docosahexaenoic acid-enriched formula-fed infants had better visual acuity than commercial formula-fed infants at both 17 and 52 weeks of age. Early (17-week) fatty acid profiles in blood lipids were correlated with later (52-week) visual function development in study infants. CONCLUSIONS: Results from this clinical trial demonstrate that long-chain polyunsaturated fatty acid supplementation of formula in term infants produces blood lipid fatty acid profiles that are similar to those observed in breast-fed infants. This supplementation leads to better visual function later in life (i.e., 1 year of age) than that shown by infants fed commercial formula.
In 1977 two major outbreaks of salmonella infection originated in Victoria. The first of these, involving Salmonella Bredeney, continued over some seven months and was traced to contamination of powdered milk-based infant formulae during manufacture. This caused cases of gastroenteritis among young children throughout Australia. Another incident led to the discovery that salmonella serovars were colonising not one, but a number of dairy factories through the State. The second outbreak was of typhoid, stemming from a carrier working in a sandwich bar, and occurred during the course of the first, almost overwhelming public health resources and delaying investigation of the first outbreak. The background, recognition, course, investigation and resolution of these, previously unpublished, outbreaks are described, drawing upon the experiences of authors involved at the clinical, public health and laboratory levels, and preserved, contemporary records. Taken together, these outbreaks directly stimulated radical improvements in the construction and management of dairy factories in the State; initiated the adoption of risk management concepts in food factories; caused the launch of regional regulations compelling notification of salmonellas found in food manufacture; and led to the setting-up of an enhanced national, laboratory-based system for the collection, analysis and dissemination of information on enteric pathogens.
BACKGROUND: In extremely-low-birth-weight (ELBW) infants, formula feeding is required if human milk is not available. The tolerance of a new 'high' lactose (55 g/L), low protein, low phosphate, hydrolyzed protein formula (HLF) for early enteral feeding advancement of ELBW infants was compared with that of a low lactose (1 g/L) hydrolyzed protein formula (LLF). METHODS: In a randomized multicenter trial, 99 ELBW infants were fed according to a standardized protocol beginning at 48 hours of age with 12 ml/kg daily increments. Primary outcome was the cumulative milk feeding volume (CFV) from days 3 to 14. The authors hypothesized that feeding HLF as a supplement to human milk would increase the CFV at least by 20% in at least 60% of matched pairs compared with LLF. A secondary issue was to investigate whether human milk would increase the CFV compared with formula. RESULTS: The CFV was 720 mL/kg (range, 0-962 mL/kg) with HLF and 613 mL/kg (range, 3-1,283 mL/kg) with LLF feeding. There was no 20% difference. On day 14, the median feeding volume was 103 mL/kg. The CFV was 533 mL/kg (range, 0-962 mL/kg) in infants who received less than 10% of human milk and 832 mL/kg (range, 74-1,283 mL/kg) in infants who received more than 10%. Necrotizing enterocolitis (Bell stage > or =2) occurred only with LLF feeding (n = 5; P < 0.05). CONCLUSIONS: The study failed to find the hypothesized 20% advantage of the new HLF. The observed advantage of human milk supports the hypothesis that it should be the first diet in ELBW infants; however, this hypothesis still must be confirmed in a controlled, randomized trial.
Dietary potassium intake in patients with chronic renal failure is generally reduced by oral administration of potassium-binding resins. These drugs may cause disturbances of bowel function and have an unpleasant taste. Pre-treatment of drinks with these resins and their subsequent removal may prevent these inconveniences. In four formulas (whole milk, humanised infant formula, apple juice, and orange juice) we were able to lower the potassium content by 50% with calcium polystyrene sulphonate. No important increase of sodium content was observed, as was reported with the use of sodium polystyrene sulphonate. There was a, potentially beneficial, increase of the calcium concentration.