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Efficacy and safety of hydrolyzed cow milk and amino acid-derived formulas in infants with cow milk allergy.

OBJECTIVE: To determine the antigenicity, nutritional adequacy, and growth-promoting efficacy of protein hydrolysate or amino acid-derived formulas in infants with cow milk allergy. STUDY DESIGN: Several protein hydrolysate or amino acid-derived formulas were graded for beta-lactoglobulin content and skin reactivity in 74 atopic children with cow milk allergy proved by a double-blind, placebo-controlled challenge. A randomized, prospective follow-up study of 9 months included 22 infants with a mean age of 6 months (95% confidence interval, 4 to 7), who were fed an extensively hydrolyzed whey formula (group We), and 23 infants with a mean age of 17 (95% confidence interval, 4 to 7) months, who were given an amino acid-derived formula (group AA). RESULTS: Both formulas were clinically and biochemically tolerated. The mean concentration of essential amino acids in plasma was lower in group We but higher in group AA compared with values for breast-fed control infants (p = 0.001). There was a different trend between the groups in weight (p = 0.09) and length (p = 0.006). Growth was promoted in group AA during the follow-up; it was constant during the first months, followed by a gradual decline in rate in group We. In both groups, atopic eczema improved significantly and progressively, and a downward trend was found in serum total and milk-specific IgE concentrations, proving the efficacy of both formulas. CONCLUSIONS: Extensively hydrolyzed formulas are safe and effective for most infants; an amino acid-derived formula may be preferable for infants with multiple food allergies, especially for the maintenance of normal growth.

Amino Acids↗

Do infants with cystic fibrosis need a protein hydrolysate formula? A prospective, randomized, comparative study.

OBJECTIVES: We compared the nutritional benefits of a protein hydrolysate and a conventional infant formula in infants newly diagnosed with cystic fibrosis (CF). STUDY DESIGN: Twenty-three infants with CF (<6 months of age) and pancreatic insufficiency were randomized to receive a hydrolysate formula (Alimentum) or a cow's milk-based formula (Similac). Each patient was monitored at 1 month and then every 3 months for 1 year. RESULTS: Eighteen patients (8 Alimentum, 10 Similac) completed the study. At entry, the age distribution and clinical characteristics of each group were comparable. Energy intake with each formula was the same at 1 and 3 months, but at 6 and 12 months the hydrolysate-fed infants had higher age-adjusted energy intake. There were no differences in fecal energy or fecal fat at entry or throughout the study. Although the hydrolysate-fed infants were slightly more malnourished at diagnosis, growth velocity and nutritional status of infants with CF in each group were the same throughout the study. CONCLUSIONS: The results of this randomized study fail to support the use of a hydrolyzed formula for the routine care of infants newly diagnosed with CF.

Cystic Fibrosis↗

Impact of supplementary food on intake of breast milk in diarrhoea.

The intake of breast milk during acute and early convalescent stages of diarrhoea (over a 7-day period) and a fortnight after discharge from hospital (late convalescent stage) was monitored in 33 breastfed children aged 8-24 months. 16 were exclusively breastfed and 17 were partially weaned at the time of admission. On admission, weaning food was introduced to the exclusively breastfed children, whose intake of breast milk in the acute stage made up slightly more than half the total calorie intake of 70 +/- 4 kcal/kg/day. Their total calorie intake increased to 91 +/- 5 and 103 +/- 5 kcal/kg/day in the early and late convalescent stages, respectively, but the proportion made up by breast milk dropped to about a quarter. The breast milk intake of the partially weaned children made up nearly half their total calorie intake of 72 +/- 5 kcal/kg/day, and about a fifth of their total calorie intake of 94 +/- 5 kcal/kg/day and 104 +/- 5 kcal/kg/day, respectively, during the early and late convalescent stage, respectively.

Bacterial Infections↗

Nutritional aspect of zinc availability.

Zinc is an essential trace element in human nutrition and its deficiency is a world nutritional problem. However, the zinc content of foods is low and its availability is conditioned by several physiologic and dietary factors. For that reason, the objective of the present work is to compile past and present information about the influence of these factors on zinc availability to try to improve this availability.

Adult↗

Low calorie bulking agents.

Obesity, a common disorder causing excess mortality due to the development of cardiovascular disease, hypertension, respiratory illness, and diabetes, is difficult to control by simple dieting techniques. Low calorie foods, which can facilitate newer weight reduction approaches such as behavior modification, often lack adequate palatability due to the absence of carbohydrate or fat. Various low calorie bulking agents that can replace the traditionally used carbohydrates and fats are discussed in terms of caloric value, utility, and regulatory status. Methods of measuring caloric utilization of bulking agents in test animals and humans are evaluated. For fat, no really satisfactory replacement is currently available, although several promising are under development. Dietary fiber sources such as microcrystalline cellulose are receiving considerable attention as flour replacements. While the polyols have many desirable attributes, as sucrose replacements, their caloric utilization values generally prevent a significant caloric reduction when they are used in foods. Several experimental sucrose replacements are described.

Adult↗

Effects of dietary viscosity and energy density on total daily energy consumption by young Peruvian children.

BACKGROUND: Results of prior studies of the effect of viscosity reduction of high-energy-density, starch-containing diets on young children's energy intakes are inconsistent, possibly because of differences in the characteristics of the unmodified diets with which the low-viscosity diets were compared. OBJECTIVE: Our objective was to determine the effects of dietary viscosity and energy density on total daily energy consumption by young, non-breast-fed children. DESIGN: We measured the amount of food consumed and the duration of meals during 3 substudies, in each of which 3 study diets were offered for 4 consecutive days each in random sequence: high energy density, high viscosity (HD-HV); high energy density, low viscosity (HD-LV); and low energy density, low viscosity (LD-LV). The viscosity and energy density of the unmodified starch-containing HD-HV diet were varied across substudies to determine whether the effect of amylase liquefaction was related to the initial characteristics of the HD-HV diet. The viscosity of the HV diets ranged from 79000 to 568000 mPa s; energy density of the HD diets ranged from approximately 4.18 to 4.93 kJ (1.00-1.18 kcal)/g. Viscosity of the LV diets was approximately 3000 mPa s and the energy density of the LD diets was approximately 2.47 kJ (0.6 kcal)/g. RESULTS: In each substudy, children consumed more of the LD-LV diet (g kg body wt(-)(1) d(-)(1)) than of the other diets and more of the HD-LV diet than of the HD-HV diet (P < 0.001). Energy consumption from the HD-LV diet was greater than from the other diets (P < 0.001), but the energy intakes from the latter diets were not significantly different. CONCLUSION: Amylase liquefaction of HD-HV porridges resulted in increased energy consumption by young children.

Anthropometry↗

Plasma and red blood cell fatty acids of low-birth-weight infants fed their mother's expressed breast milk or preterm-infant formula.

The fatty acid composition of plasma phospholipids, red blood cell (RBC) phosphatidylcholine (PC), and phosphatidylethanolamine (PE) was determined for low-birth-weight (LBW) infants when full oral feeding commenced (day 0) and after a further 28 d (day 28). They were fed their mother's expressed breast milk (PTM, n = 9), formula (SCF, n = 16) with 2% 18:3n-3 fatty acids, 20% 18:2n-6 fatty acids, or a combination of SCF and PTM (n = 11). Concentrations of all 20- and 22-carbon n-6 and n-3 fatty acids were similar among the infant groups on days 0 and 28 (mean postnatal age 42 +/- 1.3 d). The results suggest that formula with greater than or equal to 2% 18:3n-3 and a ratio of 18:2n-6 to 18:3n-3 similar to that of human milk may permit incorporation of n-3 fatty acids in LBW infant tissues equivalent to that from human milk.

Erythrocytes↗

Iron status and intake of older infants fed formula vs cow milk with cereal.

One hundred four infants were randomly assigned to receive whole cow milk plus iron-fortified cereal (WCM + C) in accord with the previous recommendations of the Committee of Nutrition/American Academy of Pediatrics (CON/AAP); one of two iron-fortified, follow-up formulas; or an iron-fortified infant formula. Mean iron intakes and vitamin C exceeded the recommended dietary allowance in all groups. By 12 mo of age, mean ferritin and mean corpuscular volume were lower in the WCM + C group and significantly more infants had serum ferritin concentrations < 12 micrograms/L. We conclude that infants 6-12 mo of age fed whole cow milk and iron-containing table food are at risk of developing depleted iron stores but not anemia. The iron insufficiency in these infants is not due to inadequate intake of iron or vitamin C, but probably to relatively poor bioavailability of iron in infant cereal.

Animals↗

Palm olein in infant formula: absorption of fat and minerals by normal infants.

Palm olein, a low-melting fraction of palm oil, and soy oil can be combined to obtain fat blends with proportions of palmitic and oleic acids similar to those of human milk. We compared the absorption of fat and calcium by infants fed a formula containing a blend of palm olein (53%) and soy oil (47%) (Formula PO/S) with that by infants fed a formula containing a blend of soy oil (60%) and coconut oil (40%) (Formula S/C). In a randomized crossover design, one study was performed with each formula in each of 11 normal infants ranging in age from 27 to 161 d. Six of the infants were admitted for 72-h metabolic balance studies. In the other five infants, feces (with some admixture of urine) were collected at home for 96 h by using acid-washed cloth diapers. Mean (+/- SD) absorption of fat was 90.6 +/- 1.6% of intake when Formula PO/S was fed and 95.2 +/- 1.1% of intake when Formula S/C was fed; the difference was significant (P < 0.001). The difference in excretion of fat by infants fed the two formulas was explained by the difference in excretion of palmitic acid. Absorption of calcium averaged 39.0 +/- 8.3% of intake with Formula PO/S and 48.4 +/- 10.3% with Formula S/C; the difference was significant (P < 0.01). We conclude that fat is less well absorbed from a mixture of 53% palm olein and 47% soy oil than from a mixture of 60% soy oil and 40% coconut oil, and that absorption of calcium is less from a formula containing palm olein, presumably because of the formation of insoluble calcium soaps of unabsorbed palmitic acid.

Absorption↗

Feeding behavior in neonates whose diet contained medium-chain triacylglycerols: short-term effects on thermoregulation and sleep.

BACKGROUND: Feeding formulas for premature infants often contain medium-chain triacylglycerols (MCTs). However, previous studies in animals and adults showed that MCTs may decrease food intake. OBJECTIVES: The objectives were to determine in hospitalized premature infants whether food intake is modified by dietary MCT supply and to assess the effects on thermoregulation and sleep, which are involved in the regulation of energy metabolism and in the optimal physiologic development of the neonates. DESIGN: Food intake, body mass, and nutritional efficiency during 3 consecutive days were compared in 2 groups of neonates according to the fat composition of their feeding formula [MCT group: 37% MCT, 63% long-chain triacylglycerols (LCTs); LCT group: 100% LCT]. On the third day, sleep and metabolic rate were recorded in the morning during an interval between meals. RESULTS: Regardless of day, energy intake was greater in the MCT group than in the LCT group (x difference: 67.3 kJ x kg(-1) x d(-1); P = 0.007). Metabolic rate (1.8 mL x min(-1) x kg(-1); P < 0.001), cheek skin temperature (0.31 degrees C; P = 0.04), and total sleep time (52 min; P = 0.01) were also higher in the MCT group. CONCLUSION: The ratio of MCTs to LCTs in neonates' feeding formulas can modify physiologic functions involved in energy-balance regulation.

Body Temperature Regulation↗

An approach to setting maxima in infant formulas.

It is clearly necessary to set upper limits for a nutrient in a formula where the nutrient can have a direct toxic effect (e.g., vitamin A) or can lead to a reduced margin of safety (e.g., high dietary renal solute load during gastroenteritis). In addition, there are plausible arguments for setting upper limits for any nutrient added during manufacture. Various expert groups have used different approaches in setting upper limits, particularly for fat and minerals. Evidence of clinical toxicity and various biochemical measurements have been commonly used to determine appropriate upper levels. Less use has been made of the empirical evidence provided by nutrient concentrations in commonly used foods, e.g., breast milk and cow's milk. Four "rules" for setting maxima are suggested: a) Use evidence of clinical toxicity or reduced margin of safety if available; b) Avoid nutrient concentrations that lead to biochemical values in body fluids or tissues very different from those seen in breast-fed babies; c) An upper limit should be set for even apparently harmless nutrients that are added during manufacture; and d) When a nutrient is added, its final concentration should not normally exceed that in breast or cow's milk, whichever is the greater. Using these "rules," suggested maxima for 33 nutrients are listed.

Female↗

Potential renal solute load of infant formulas.

The potential renal solute load (PRSL) of infant feedings is the sum of dietary nitrogen (expressed as mmol of urea, i.e., mg nitrogen divided by 28), sodium, potassium, chloride and phosphorus. The PRSL determines the renal solute load, and, therefore, the osmolar concentration of the urine. When water intake is reduced and/or water losses are increased, the renal concentrating ability may be exceeded, and negative water balance (dehydration) may ensue. Under these circumstances, feedings providing high PRSL lead more rapidly to dehydration than do feedings providing lower PRSL. On the basis of simulated clinical situations and epidemiologic data, it is concluded that conventional infant formulas (PRSL 135-177 mosmol/l, or 20-26 mosmol/100 kcal) provide a satisfactory margin of safety. A feeding providing the upper limits for concentrations of protein and electrolytes specified by the Food and Drug Administration rule does not afford a satisfactory margin of safety. It is recommended that the upper limit for protein content of infant formulas be decreased from 4.5 g/100 kcal to 3.2 g/100 kcal and that an upper limit for phosphorus concentration of infant formulas be set at 93 mg/100 kcal. Maximum PRSL will then be 221 mosmol/l (33 mosmol/100 kcal).

Electrolytes↗

Adaptation to high protein intakes, with particular reference to formula feeding and the healthy, term infant.

The purpose of this paper is to attempt to define the upper limit of the safe range of protein intake, with particular reference to the protein content of prepared fixed-formulas used for feeding healthy, term infants. For discussion purposes we use the current upper limit proposed by the U.S. Food and Drug Administration (FDA), namely, 4.5 g protein per 100 kcal, as our initial reference level. To help reach a conclusion, the concept and definitions of nutritional adaptation and accommodation are considered, followed by a brief review of selected studies in full-term infants fed varying levels of protein intake. Based on growth and blood biochemical data, principally plasma free amino acid levels, we conclude that the currently proposed FDA upper limit is probably too high. The available data support a recommendation for lowering the value to about 3.5 g of protein per 100 kcal. Concerns for renal solute load (RSL) may require a further, desirable refinement in the value proposed. Indeed RSL should perhaps serve as the primary basis for establishing a rational and safe upper limit for the protein content of prepared fixed-formula diets for the very young, healthy infant.

Adaptation, Physiological↗

Upper limits of intakes of total fat and polyunsaturated fatty acids in infant formulas.

The upper limit for fat in infant formulas in the United States is 6 g per 100 kcal. This concentration of fat, similar to that of human milk, seems appropriate for fats that are well absorbed. The upper limit for linoleic acid recommended by the working party in the United Kingdom was 1200 mg per 100 kcal. However, there seems to be no evidence that a higher percentage does the infant any temporary or permanent harm.

Dietary Fats↗

Upper limits of vitamin A in infant formulas, with some comments on vitamin K.

Current Food and Drug Administration (FDA)-approved levels of adequacy and of upper limits in infant formulas for vitamin A are 250 and 750 IU per 100 kcal, respectively. The level of adequacy is generous relative to need. Because vitamin A toxicity has been noted in infants at intakes of 2,100 IU per 100 kcal, an upper limit might well be selected in the range of 750-1,000 IU per 100 kcal for healthy infants. Some children and adults, however, are intolerant of relatively low intakes. The current FDA-approved adequacy level for vitamin K is 4 micrograms per 100 kcal, which also is generous relative to need. An upper limit has not previously been set. Neither single intramuscular doses of phylloquinone that are 100 times the RDA (RDI) for infants nor diets that contain 10-20 times the RDA (RDI) for adults show any adverse effects. Some allergic reactions to injected vitamin K have been reported, however, and menadione, even in low doses, shows significant toxicity in neonates. Thus, although toxicity to phylloquinone is unlikely, it has been suggested that the upper limit of phylloquinone in infant formulas be set at 20 micrograms per 100 kcal, primarily to discourage nutritionally unwarranted supplementation.

Female↗

Upper limit of vitamin E in infant formulas.

Reports of toxicity to enterally administered vitamin E are rare in infants. However, increased risks of sepsis and necrotizing enterocolitis have been reported after both enteral and parenteral vitamin E, primarily when plasma (or serum) vitamin E levels exceed 3.5 mg/dl. Levels this high are seldom seen with enteral vitamin E when intake is 25 mg d-alpha-tocopherol equivalent/(kg.d) or less. Intakes below this threshold will be provided by infant formulas with vitamin E to energy ratios of up to 20 mg/100 kcal (30 IU/100 kcal) so long as energy intake does not exceed 125 kcal/(kg.d). To allow a margin of safety, it would be reasonable to limit the amount of vitamin E added to the formula during its manufacture to half this amount, or 10 mg/100 kcal (15 IU/100 kcal). This level coincides with the highest levels of vitamin E found in human colostrum and is 20 times the recommended lower limit for vitamin E in infant formula of 0.5 mg/100 kcal.

Adult↗