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[Sugar substitutes in specialized child nutrition products for the prevention and treatment of diabetes mellitus].
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Uneasy prelude to meeting on infant feeding.
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Prevention of anaemia in inner-city toddlers by the use of a follow-on formula.
Results of research into preventing iron-deficiency anaemia in inner-city toddlers, published in full in Archives of Disease in Childhood (1996; 75: 9-16), are discussed by the authors. In a prospective study, 100 infants already receiving pasteurised cow's milk by six months old were randomly divided into two groups, one to receive a follow-on formula and the other to continue on cow's milk until aged 18 months. At 18 months one-third of the cow's milk group were anaemic compared with 2% of the formula group. The authors consider that if the same volume of standard infant formula had been given instead of a follow-on formula, substantially fewer of the children would have reached the correct reference nutrient intake for iron.
Changing infant formula. When is it warranted?
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[Effect of nucleotides as dietary supplement on diarrhea in healthy infants].
OBJECTIVE: The objective of this study was to evaluate the effect of nucleotide supplements on the incidence, duration and severity of diarrhea in healthy infants. PATIENTS AND METHODS: A total of 3,243 cases were studied. This was an observational cohort study with a 1:1 ratio between infants receiving a nucleotide supplemented/unsupplemented diet. From the start of the study until the infant reached 6 months of age, the infant's mother recorded the duration and severity of each episode of diarrhea. The infant's height and weight were measured at the beginning and at the end of the follow-up period and the nutritional index (NI) was calculated [NI = (actual weight/actual height)/(ideal weight/ideal height)/100]. Data collection was performed during the months of June through December 1996 at 340 pediatric clinics distributed throughout Spain. RESULTS: The study groups were found to be homogeneous and there were no significant differences in age, gender, duration of follow-up, referring pediatric offices, number of siblings, usual residence, habitat or nursery attendance. The incidence of diarrhea was significantly lower (p < 0.001) in the nucleotide supplemented group (11.1%) versus the unsupplemented group (17.4%). Similarly, both the maximum duration of diarrhea (p < 0.05) and the severity of episodes of diarrhea (p < 0.001) were significantly lower in the nucleotide supplemented group. No significant differences were found between the initial and final nutritional indexes within a group nor when comparing the two groups. CONCLUSIONS: Nucleotide supplemented starter formulas reduce the incidence, duration and severity of diarrhea in healthy infants, but weight and height were not affected.
Amylase rich food: a new dimension in weaning and management of malnutrition.
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The effect of food on the bioavailability of ibuprofen and flurbiprofen from sustained release formulations.
The effect of food on the plasma concentration-time profile of sustained release dosage forms of ibuprofen and flurbiprofen has been investigated in healthy Asian Indian volunteers, in two separate studies. In study 1, 20 volunteers were administered a single 200 mg multiple-unit sustained release capsule of flurbiprofen (Froben SR), after an overnight fast or a heavy vegetarian breakfast. Food produced a statistically significant increase in the mean (+/-SE) maximal plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC0-48). Cmax (+/-SE) increased from 9.88 +/- 0.48 mg L-1 (fasting) to 11.36 +/- 0.88 mg L-1 (postprandial) and AUC0-48 (+/-SE) increased from 120.78 +/- 9.64 mg h L-1 (fasting) to 149.73 +/- 12.24 mg h L-1 (postprandial). The mean (+/-SE) time to peak (tmax) was also significantly delayed from 3.85 +/- 0.27 h to 8.70 +/- 0.89 h. In study 2, 18 volunteers were administered a single 800 mg erodible sustained release matrix tablet of ibuprofen (Brufen Retard), after an overnight fast or along with a heavy vegetarian breakfast. The formulation exhibited multiple peaks (n > or = 2) on the plasma concentration-time curve. Although food did not affect the bioavailability of this formulation, there was a statistically significant increase in the mean (+/-SE) concentration of the first peak (Cpeak 1) from 14.21 +/- 1.38 mg L-1 (fasting) to 20.14 +/- 1.38 mg L-1 (with food). The time at which Cpeak 1 was reached was not influenced by the intake of food. Results indicate that while qualitative changes in the plasma concentration versus time curves are primarily influenced by the nature of the formulation and the type of meal, bioavailability is influenced by the absorption characteristics of the drug as well. Thus, despite a significant increase in peak plasma concentrations of both drugs with a meal, the bioavailability of flurbiprofen alone was enhanced.
Bioavailability of lansoprazole granules administered in juice or soft food compared with the intact capsule formulation.
BACKGROUND: The ability to administer the contents of an encapsulated-dose formulation in liquids or soft foods without compromising drug bioavailability is highly desirable for patients who are unable to swallow or have difficulty swallowing. OBJECTIVE: The purpose of this study was to compare the bioavailability of lansoprazole granules administered in 2 types of juice and a soft food with that of the intact capsule administered with water. METHODS: Healthy adult volunteers were eligible for this single-center, Phase I, single-dose, randomized, open-label, 4-period crossover study. Subjects received the enteric-coated granular contents of a 30-mg lansoprazole capsule in 3 test regimens (in 180 mL of orange juice, 180 mL of tomato juice, or 1 tablespoon of strained pears, each followed by 180 mL of water) and 1 reference regimen (the 30-mg intact capsule with 180 mL of water). The regimens were rotated at > or = 6-day intervals so that each subject received all 4 regimens. Blood samples for pharmacokinetic analyses were obtained during the 12 hours after each regimen. RESULTS: Twenty healthy adult volunteers (10 men, 10 women; mean age, 36 years [range, 19-53 years]) completed this study. Bioavailability of the 3 test regimens was assessed using the two 1-sided tests procedure for mean maximum plasma concentration and area under the plasma concentration-time curve (AUC) from time 0 through the last measurable concentration and AUC from time 0 to infinity. These results were compared with that of the intact capsule. This comparison indicated that the 90% CIs for all 3 test regimens were within the acceptable bioequivalence range of 0.80 to 1.25. Lansoprazole was well tolerated, with most of the adverse events being mild. Headache was the most frequently reported adverse event. CONCLUSION: The results of this study indicate that the bioavailability of lansoprazole granules, when administered in orange juice, tomato juice, or a small amount of strained pears, was similar to that of the intact capsule in these healthy adult volunteers.
Focus on substitutes that alter gastrointestinal physiology.
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Concluding remarks on the proposed safety appraisal framework for evaluating macronutrient substitutes.
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Myocardial changes in newborn piglets fed sow milk or milk replacer diets containing different levels of erucic acid.
This study was undertaken to determine whether the neonate was more susceptible to the effects of dietary erucic acid (22:1n-9) than the adult. Newborn piglets were used to assess the safety of different levels of 22:1n-9 on lipid and histological changes in the heart. Newborn piglets showed no myocardial lipidosis as assessed by oil red 0 staining, but lipidosis appeared with consumption of sow milk and disappeared by seven days of age. Milk replacer diets containing soybean oil, or rapeseed oil mixtures with up to 5% 22:1n-9 in the oil, or 1.25% in the diet, gave trace myocardial lipidosis. Rapeseed oil mixtures with 7 to 42.9% 22:1n-9 showed definite myocardial lipidosis in newborn piglets, which correlated to dietary 22:1n-9, showing a maximum after one week on diet. The severity of the lipidosis was greater than observed previously with weaned pigs. There were no significant differences among diets in cardiac lipid classes except for triacylglycerol (TAG), which increased in piglets fed a rapeseed oil with 42.9% 22:1n-9. TAG showed the highest incorporation of 22:1n-9, the concentration of 22:1n-9 in TAG was similar to that present in the dietary oil. Among the cardiac phospholipids, sphingomyelin and phosphatidylserine had the highest, and diphosphatidylglycerol (DPG) the lowest level of 22:1n-9. The low content of 22:1n-9 in DPG of newborn piglets is not observed in weaned pigs and rats fed high erucic acid rapeseed oil. The relative concentration of saturated fatty acids was lowered in all cardiac phospholipids of piglets fed rapeseed oils, possibly due to the low content of saturated fatty acids in rapeseed oils. The results suggest that piglets fed up to 750 mg 22:1n-9/kg body weight/day showed no adverse nutritional or cardiac effects.
Effect of environmental factors on the development of allergic disorders in infancy.
A total of 1167 infants were followed for 1 year in a population-based prospective study to assess the effect of environmental factors on the development of allergic disorders. Some of these environmental factors are interdependent. Mothers who formula fed their infants smoked more often (p less than 0.001) and tended to belong to lower social classes (p less than 0.01). Logistic regression analysis was performed to adjust for these confounding variables. Maternal smoking adversely affected the prevalence of asthma (p = 0.003) defined as three or more separate episodes of wheezing and total allergy (p = 0.02). Infants in lower socioeconomic groups developed asthma significantly more often (p = 0.03) than infants born in higher socioeconomic groups. There was a nonsignificant trend for infants born in summer to develop asthma more than infants born in winter (p = 0.08). No effect of these factors was observed on eczema, food intolerance, or on the subgroup of infants with definite allergy (clinical disorder with positive skin prick test [SPT]). Exposure to animal dander did not influence the prevalence of clinical disorder, but positive SPT reaction to cat dander was more prevalent in infants who were exposed to cats and/or dogs (p = 0.04). Positive SPT to house dust mite occurred significantly more often in infants who were formula fed (p = 0.05). The environmental factors had a profound effect on the prevalence of asthma but not on other allergic disorders.
Rapid separation of soybean globulins by reversed-phase high-performance liquid chromatography.
A rapid separation of the main soybean proteins (7S and 11S globulins) was carried out by reversed-phase high-performance liquid chromatography. For this purpose, a linear binary gradient acetonitrile--water--0.1% trifluoroacetic acid, at a flow-rate of 1 ml/min and 50 degrees C temperature was designed. Under the experimental conditions of this work, it was possible to separate five peaks corresponding to the globulins from a soybean protein isolate in 9 min. The characterization of soybean proteins was accomplished by analyzing the 7S and 11S purified fractions obtained from a soybean protein isolate. The method was applied to the separation of soybean proteins from commercial foodstuffs: soybean flour, textured soybean and soybean milks.
The natural history of intolerance to soy and extensively hydrolyzed formula in infants with multiple food protein intolerance.
Infants (n = 18) with intolerance to extensively hydrolyzed formulas and soy who responded to an L-amino acid-based elemental formula (AAF) were studied until 3 years of age. By 2 years of age most tolerated non-formula foods, and by 3 years only 3 required AAF. Growth normalized during AAF feeding in 4 infants with failure to thrive.
[Allergy to protein hydrolysates. Report of 30 cases].
AIM OF THE STUDY: To describe the population of children allergic to cow's milk protein and their usual substitutes made of protein hydrolysates, and who are efficiently taken care of by using Neocate, an amino acid based formula. PATIENTS AND METHODS: Allergy to protein hydrolysates was diagnosed in 30 infants, aged from 15 d to 13 months (median = 3 months), who remained symptomatic while receiving a protein hydrolysate for 15 d to 12 months (median = 1.8 months). After a complete clinical and biological evaluation, an amino acid based diet using Neocate was attempted, followed after one month by an oral challenge test with the protein hydrolysate. RESULTS: Symptoms occurred mainly in the digestive tract (25 cases) in the form of regurgitations (18 cases), diarrhea (17 cases) and colicky pain (10 cases); failure to thrive was seen in ten cases. Neocate improved the clinical condition rapidly (within 3-10 d), and allowed the children to gain weight (27.5 +/- 10.8 g/d). Skin prick tests with cow's milk hydrolysates were positive in 13 out of 26 children; total IgE was raised in cases of cutaneous symptoms (six cases), and associated with increased specific IgE for cow's milk. During the intestinal permeability test, the lactitol/mannitol ratio which initially increased, decreased following Neocate (6.58 +/- 2.92% vs. 3.47 +/- 1.58%, P = 0.0004). Multiple food allergies were present in 22 cases. During challenge with a hydrolysate, the clinical reaction was immediate in 13 cases, partially delayed in 13 cases and delayed in four cases. CONCLUSION: Allergy to cow's milk hydrolysates may occur and has to be considered in the presence of anaphylaxis and also chronic digestive symptoms such as regurgitations, diarrhea and colicky pain, when these symptoms persist during cow's milk free diet.
[Protein and energy needs of the infant with severe malnutrition. Application in a hospital environment for the treatment of malnutrition caused by deficient intake].
Severe malnutrition is defined by a weight for height below 70% of international standards or by presence of oedema in a clinically undernourished child. Severe malnutrition associated with oedema is called kwashiorkor. The origin of oedemas of kwashiorkor is still debated, but its relation with protein deficiency is strongly questioned. The same dietary management is now recommended for malnutrition with or without oedema. Present recommendations are based, as for well nourished children, on the separate estimation of nutritional requirements for maintenance and growth. Total requirements vary between 0.7 g/kg/day in the first few days of treatment to 5 g/kg/day or more when weight gain is maximum. As a result of high energy requirement during catch-up growth, protein requirements never exceed 10 to 12% of total energy needs.
[Cholestasis syndrome in newborn infants: value of gallbladder ultrasound].
PURPOSE: Evaluation of sonography in the assessment of changes of the biliary system of newborn infants receiving total parenteral nutrition. PATIENTS AND METHODS: In 20 premature infants on mechanical ventilation, the influence of two different amino acid solutions (Vaminolac, Paedamin) in the development of neonatal cholestasis was analysed. The patients were randomised in two groups. Group 1 (n = 11) received Paedamin, group 2 (n = 9) received Vaminolac. RESULTS: There was no statistically significant influence of the amino acid solution on the development of cholestasis. However, the majority of the children with cholestasis (8 of 11) presented with sepsis. CONCLUSION: Bacterial infections seem to be closely related to the development of cholestasis. Sludge formation within the bile ducts represents a sensitive sonographic parameter for the diagnosis and follow-up of cholestasis secondary to total parenteral nutrition.