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PubMed2000

Randomized multicenter trial documenting the efficacy and safety of a lactose-free and a lactose-containing formula for term infants.

OBJECTIVE: To evaluate the efficacy and safety of a new lactose-free infant formula. DESIGN: Randomized, prospective, double-blind, controlled, outpatient, multicenter, parallel 12-week trial. SETTING: Ambulatory-care facilities of the participating centers. SUBJECTS: 137 healthy term infants (approximately 7 days old at the time of study enrollment). INTERVENTION: Healthy term infants, whose mothers had decided not to breast-feed, were randomly assigned 1 of the 2 study formulas. MAIN OUTCOME MEASURES: Weight, length, and occipitofrontal circumference measurements were obtained at baseline and when the infant was 2, 4, 8, and 12 weeks old. Formula acceptance and tolerance were also assessed at weeks 2, 4, 8, and 12. Serum albumin concentration, creatirune level, and blood urea nitrogen were determined at baseline and week 12. Adverse events were assessed throughout the study. STATISTICAL ANALYSES PERFORMED: Each baseline anthropometric and laboratory variable was analyzed for comparability between groups using the Student t test and was also analyzed using a repeated-measures analysis of variance method. Covariance analysis was applied to the final laboratory data using the respective baseline data as covariates. Decisions about equality of mean responses to formula effects were based on the .05 level of significance in all cases. RESULTS: One hundred four infants completed the study. No significant differences between the 2 formula groups were noted for any of the growth and blood parameters. APPLICATIONS: This new formula is an effective and safe lactose-free nutrition alternative for infants who require such a diet.

Anthropometry↗
PubMed2000

Crying and behavior pattern in breast- and formula-fed infants.

Breast- and formula-fed infants were compared with regard to behavior patterns, especially crying behavior. A diary concerning seven behaviors was completed by 188 mothers of breast- and formula-fed infants at the well baby clinic. Breast-fed infants were fed more frequently with longer feeding duration. They slept more, but their long bouts were shorter than those of formula-fed infants. The crying pattern of formula-fed infants was different from that of breast-fed infants in that they displayed an evening cluster and a 7-week peak of crying. Since the educational level of the formula group mothers was higher and there are more later born babies in that group, it is speculated that these mothers have a Westernized tendency in their caretaking style and, as a result, the crying pattern of formula-fed infants are similar to that of Western babies. In multivariate analysis, contact, play, sleep durations and mothers' education contributed significantly to cry duration. These results imply that contact with the mother and other caretaking practices are closely associated with infants' crying.

Adult↗
PubMed1991

Ecology of accelerated natural lactic fermentation of sorghum-based infant food formulas.

Accelerated natural lactic fermentation of mixed sorghum-cowpea (Formula 1) and sorghum-milkpowder (Formula 2) infant food formulas was achieved by repetitive (60 fermentation cycles of 24 h each) use of the previous batch as an inoculum at a rate of 10% (w/w) and resulted in a gradual establishment of mixed populations of lactic acid bacteria and yeasts. In Formula 1, early fermentation stages (fermentation cycles 1-4) were dominated by Leuconostoc and Lactococcus spp. which caused conditions inhibitive to yeasts. Probably due to micronutrient deficiencies, the former lactic acid bacteria were succeeded by a combination of Lactobacillus plantarum and Candida spp. achieving pH values 4.2-4.3. In formula 2, Lactobacillus acidophilus, Lactococcus lactis and Lactobacillus brevis consistently achieved pH 3.7-3.8, thereby allowing only a minority of yeasts, mainly Candida and Trichosporon spp. None of the isolated yeasts exhibited 'killer'-activity.

Animals↗
PubMed1991

[Evaluation of a new Israel infant soy formula].

A new infant soy formula has recently been developed in Israel and is being produced (Materna Tsimchit, Trima Industries, Kibbutz Ma'aborot). We compared its efficacy with that of a well-known imported soy formula (Isomil, Ross Laboratories, USA) in a prospective, randomized, double-blind study. 45 normal infants, aged 1-6 months, were monitored for over 2 months after the soy formula was started either because of cow-milk allergy or lactose intolerance. 22 received Materna Tsimchit and 23 Isomil. The study revealed no significant differences between the products with regard to compliance, behavior, symptoms, physical examination (including growth parameters and nutritional assessment), stool characteristics and complete blood counts. We conclude, given the limitations of the present study, that the new Israeli product is as effective as the foreign product.

Growth↗
PubMed1980

The metabolic consequences of human milk and formula feeding in premature infants.

Twenty premature low-birthweight infants were divided into two groups and assigned randomly to either a pooled human milk or to a cow's milk based infant formula feeding regimen. The protein intake was 2.0 g/kg/day in the human milk fed group and 4.4 g/kg/day in the formula fed group of infants. The concentrations of different metabolites were estimated at weekly intervals, and plasma amino acid analysis was performed biweekly on blood samples in the two groups of infants during the four-week study period. Formula milk fed infants had significantly lower fasting blood glucose levels and developed azotaemia, hyperaminoacidemia and metabolic acidosis in the early weeks of postnatal life. Blood lactate and plasma free fatty acid concentrations did not change significantly in the two groups during the study. No significant differences were found in the rate of weight gain between the two groups of infants, although formula fed infants regained their birthweight more slowly than human milk fed infants. High protein formula feeding causes potentially unfavorable metabolic and amino acid imbalances in preterm infants in the early postnatal life.

Amino Acids↗
PubMed1998

Plasma and erythrocyte alpha-tocopherol and plasma retinol concentrations in term infants fed formula enriched with long-chain polyunsaturated fatty acids.

OBJECTIVE: To assess the effect of long-chain polyunsaturated fatty acids (LCPUFA)- and vitamin E-supplemented formula feeding on erythrocyte and plasma alpha-tocopherol (VE), and plasma retinol (VA) concentrations in neonates and to compare these values with those found in infants feeding on infant formula without LCPUFA or breast milk SETTING: University Hospital of Granada, Spain. SUBJECTS: 49 full-term infants. DESIGN AND INTERVENTION: Subjects who chose not to breast feed were fed either (i) unsupplemented infant formula (F) or (ii) infant formula supplemented with LCPUFA and vitamin E (FL). Alpha-tocopherol and retinol were measured at 7 days, 1 month and 3 months. RESULTS: Plasma and erythrocyte VE concentrations and plasma VE/total lipids ratio increased significantly in all groups at 1 month of life (P < 0.05), but did not change significantly between 1 month and 3 months in any group (P > 0.05). Erythrocyte VE and VA retinol concentrations were higher in infants fed an infant formula than in breast milk-fed infants at 1 month of life (P < 0.05). Finally, there were no significant differences in plasma or erythrocyte VE levels, plasma VA or plasma VE/total lipid ratio between any groups at 3 months of life (P > 0.05). CONCLUSION: Infants fed on LCPUFA- and vitamin E-supplemented infant formula for 3 months have similar vitamin E and A status to infants fed on breast milk or infant formula without LCPUFA supplementation.

Adult↗
PubMed2003

Compliance of present recommendations of fatty acids in formulas for term infants with the actual human milk fatty acid composition in different populations.

UNLABELLED: Fats are the only dietary agents possibly modulating the individual membrane composition, which otherwise is "genetically" determined. In infancy, human milk represents the first natural source of fats. Although the fat intake of breastfed infants is quantitatively and qualitatively unique, it is not known to what extent their varying requirements are met by the fat composition in the milk of their mothers. CONCLUSION: The fat composition of arbitrarily chosen human milk is not always the best standard for that in infant formula.

Breast Feeding↗
PubMed1998

Bone mineral content is not reduced despite low vitamin D status in breast milk-fed infants versus cow's milk based formula-fed infants.

The effect of low or borderline vitamin D status on bone mineralization of exclusively breast milk-fed infants has not been studied. The low vitamin D status of Korean breast milk-fed infants may theoretically have adverse effects on bone mineralization. Assuming that bone mineral content (BMC) relates in part to vitamin D status, we hypothesized that serum 25-hydroxyvitamin D (25-OHD) concentration and BMC would be low, and serum osteocalcin concentration high, reflecting active bone turnover, in breast milk- versus formula-fed infants born in the winter. Eighteen breast milk- and 17 formula-fed infants were recruited at ages 2 to 5 months. The BMC of the lumbar1-4 spine region was measured by using dual energy x-ray absorptiometry. The BMC and serum osteocalcin levels were similar for both groups. The serum 25-OHD level was significantly lower in breast milk- than formula-fed infants; 44% of the breast milk group versus 6% of the formula group had serum 25-OHD levels less than 28 nmol/L (11 ng/ml), the lower limit of normal. The BMC did not correlate with the serum 25-OHD level. Thus BMC and serum osteocalcin levels in 2- to 5-month-old infants were not different by type of feeding, despite low vitamin D status in breast milk-fed infants. We speculate that adequate mineral absorption occurs during this period from a predominantly (vitamin D independent) passive transport mechanism.

Absorptiometry, Photon↗
PubMed1986

The vitamin C status of formula-fed preterm infants.

Forty-two pairs of maternal and cord plasma vitamin C levels were determined after term, preterm, and multiple gestation pregnancies and 95 determinations of plasma ascorbate were performed on 36 premature infants who were fed a recommended infant formula throughout the first month of life. There were no significant changes of the cord or maternal ascorbate levels or of the cord/maternal ascorbate ratio between term, preterm, and multiple gestation cases. A significant negative correlation was found between the maternal ascorbate levels and the cord/maternal ascorbate ratio, supporting previous observations that high fetal blood levels of vitamin C are maintained even in cases where the maternal vitamin nutrition is poor. A rapid decline from cord levels was evident during the first week of life, followed by maintenance of relatively low plasma ascorbate levels, despite supplementation of recommended vitamin nutrition. Further monitoring of ascorbate levels in premature infants is suggested for better adjustment of the recommendations for vitamin C supplementation.

Ascorbic Acid↗
PubMed1997

Nutrient accretion in preterm infants fed formula with different protein:energy ratios.

BACKGROUND: Although standard formulas for preterm infants promote intrauterine rates of weight gain, fat deposition in preterm infants fed these formulas has been reported to be considerably higher than that in the fetus. We hypothesized that a preterm infant formula with a higher protein:energy (P:E) ratio would promote accretion rates of fat, fat-free mass, and minerals closer to those of the fetus. METHODS: As part of a larger study to determine whether accretion rates of fat and fat-free mass closer to those of the fetus can be achieved with a higher P:E ratio, we present a descriptive analysis of 72-h nutrient balance studies performed on a subset (n = 15/30) of the infants randomly assigned to be fed formula with a P:E ratio of either 3.2 g/100 kcal or 2.6 g/100 kcal. RESULTS: Despite the higher intake and net absorption of nitrogen by infants fed the higher P:E formula, there was no statistically significant difference in net nitrogen retention between groups. There also were no statistically significant differences between groups in digestible energy, metabolizable energy, energy expenditure, or energy storage. Thus, partitioning of stored energy as protein and fat did not differ between groups. The retention of calcium, phosphorus, sodium, potassium, copper, and zinc also did not differ between groups, and nitrogen intake did not affect mineral retention. CONCLUSIONS: In this study, formula for preterm infants with a P:E ratio of 3.2 g/100 kcal vs. 2.6 g/100 kcal provided no apparent benefit in terms of the proportion of fat to lean tissue accretion as determined from nutrient balance data.

Calcium↗
PubMedDate not supplied

[Infant "starting formulas" are not all equal: comparative analysis of nutritional characteristics].

Infant formulas on the market today represent the only available alternative to breast milk for infants of those women who are unable to continue breastfeeding through the first year of life, and are planned to allow artificially fed infants for approaching the structural and functional effects observed in breastfed infants. Within this context, the functional outcome of the breastfed infant (particularly as far as growth and development) well represent the gold standard. For this purpose, the following compounds have been added to starting infant formulas (planned for the first six months of life, when human milk should represent the exclusive dietary source) in recent years: long-chain polyunsaturated fatty acids (LCPUFA), for brain composition and neurodevelopment, probiotics and prebiotics for the fecal flora and the local intestinal defense, and nucleotides for promoting the immune response. Changes in protein quantity and quality allow to balance the blood amino acids pattern (possibly relevant to the early stages of brain development for the neurotransmitter function) and reducing the protein intake could be important for the prevention of later overweight. Hydrolysed proteins may be relevant in the prevention of atopic disorders. Many trials have been published so far with short-term assessment, nevertheless, we need more data on the long-term follow-up of infants who were fed the new formulas to fully understand the role of these functional compounds on the neural performance, the prevention of overweight and obesity and the development of the immune-allergic pattern.

Carbohydrates↗
PubMed2002

Gastrointestinal tolerance of a new infant milk formula in healthy babies: an international study conducted in 17 countries.

OBJECTIVE: We tested the hypothesis that the gastrointestinal tolerance of a new infant formula equals or exceeds the tolerance of other milk-based infant formulas and compared the tolerance of this new formula with that of human milk. METHODS: This prospective, phase IV, open-label study was conducted in 17 countries. Healthy, full-term infants, 28 to 98 d old, were enrolled on their current feeding (no treatment assigned). Feeding regimens included human milk (HM), a new infant formula (NF; Similac Advance), other infant formula (OF), HM + NF, and HM + OF. Data for stool frequency, stool consistency, and gastrointestinal symptoms were collected in study diaries for 2 wk. RESULTS: Gastrointestinal tolerance was evaluated in 6999 infants: 979 (14.0%) received HM, 1695 (24.2%) received HM + NF, 635 (9.1%) received HM + OF, 2677 (38.2%) received NF, and 1013 (14.5%) received OF. Infants fed HM had softer and more frequent stools than did those who received NF, HM + NF, or OF (P < 0.001). Infants fed NF had softer and more frequent stools than did those fed OF (P < 0.001), including those fed Enfalac or S-26 (P < 0.001). Regurgitation (P < 0.001) and colic (P = 0.006) were more frequent with OF than with NF. All feeding regimens were well tolerated and only 3.5% of subjects experienced adverse events. CONCLUSIONS: This global study demonstrated that stools of infants fed NF are softer and more frequent than stools from infants fed OF and are closer to those of breast-fed infants. Infants consuming NF also experienced less regurgitation and colic than did infants in other feeding groups.

Animals↗
PubMed1998

Reflections about possible nutritional supplements in infant milk formula.

The composition of infant milk formula intends to mirror breast milk as close as possible. However, there are a variety of substances, like amino acids, fatty acids, polyamines, nucleotides, oligosaccharides, functional proteins, hormones, vitamins, and minerals, which are attributed effects in special situations. A concept is proposed to develop problem oriented "supplementation packages" for infant milk formula.

Amino Acids↗