RESUMEN
BACKGROUND: 90-day mortality and rehospitalizations are important hospital quality metrics. Biomarkers that predict these outcomes among malnourished hospitalized patients could identify those at risk and help direct care plans. OBJECTIVES: To identify biomarkers that predict 90-day (primary) and 30-day (secondary) mortality or nonelective rehospitalization. DESIGN AND PARTICIPANTS: An analysis of the ability of biomarkers to predict 90- and 30-day mortality and rehospitalization among malnourished hospitalized patients. SETTING: 52 blood biomarkers were measured in 193 participants in NOURISH, a randomized trial that determined the effects of a nutritional supplement on 90-day readmission and death in patients >65 years. Composite outcomes were defined as readmission or death over 90-days or 30-days. Univariate Cox Proportional Hazards models were used to select best predictors of outcomes. Markers with the strongest association were included in multivariate stepwise regression. Final model of hospital readmission or death was derived using stepwise selection. MEASUREMENTS: Nutritional, inflammatory, hormonal and muscle biomarkers. RESULTS: Mean age was 76 years, 51% were men. In univariate models, 10 biomarkers were significantly associated with 90-day outcomes and 4 biomarkers with 30-day outcomes. In multivariate stepwise selection, glutamate, hydroxyproline, tau-methylhistidine levels, and sex were associated with death and readmission within 90-days. In stepwise selection, age-adjusted model that included sex and these 3 amino-acids demonstrated moderate discriminating ability over 90-days (C-statistic 0.68 (95%CI 0.61, 0.75); age-adjusted model that included sex, hydroxyproline and Charlson Comorbidity Index was predictive of 30-day outcomes (C-statistic 0.76 (95%CI 0.68, 0.85). CONCLUSIONS: Baseline glutamate, hydroxyproline, and tau-methylhistidine levels, along with sex and age, predict risk of 90-day mortality and nonelective readmission in malnourished hospitalized older patients. This biomarker set should be further validated in prospective studies and could be useful in prognostication of malnourished hospitalized patients and guiding in-hospital care.
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Biomarcadores , Desnutrición/mortalidad , Desnutrición/terapia , Readmisión del Paciente/estadística & datos numéricos , Anciano , Suplementos Dietéticos , Femenino , Humanos , MasculinoRESUMEN
AIMS: Among people with diabetes, 10-25% will experience a foot ulcer. Research has shown that supplementation with arginine, glutamine and ß-hydroxy-ß-methylbutyrate may improve wound repair. This study tested whether such supplementation would improve healing of foot ulcers in persons with diabetes. METHODS: Along with standard of care, 270 subjects received, in a double-blinded fashion, (twice per day) either arginine, glutamine and ß-hydroxy-ß-methylbutyrate or a control drink for 16 weeks. The proportion of subjects with total wound closure and time to complete healing was assessed. In a post-hoc analysis, the interaction of serum albumin or limb perfusion, as measured by ankle-brachial index, and supplementation on healing was investigated. RESULTS: Overall, there were no group differences in wound closure or time to wound healing at week 16. However, in subjects with an albumin level of ≤ 40 g/l and/or an ankle-brachial index of < 1.0, a significantly greater proportion of subjects in the arginine, glutamine and ß-hydroxy-ß-methylbutyrate group healed at week 16 compared with control subjects (P = 0.03 and 0.008, respectively). Those with low albumin or decreased limb perfusion in the supplementation group were 1.70 (95% CI 1.04-2.79) and 1.66 (95% CI 1.15-2.38) times more likely to heal. CONCLUSIONS: While no differences in healing were identified with supplementation in non-ischaemic patients or those with normal albumin, addition of arginine, glutamine and ß-hydroxy-ß-methylbutyrate as an adjunct to standard of care may improve healing of diabetic foot ulcers in patients with risk of poor limb perfusion and/or low albumin levels. Further investigation involving arginine, glutamine and ß-hydroxy-ß-methylbutyrate in these high-risk subgroups might prove clinically valuable.
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Arginina/administración & dosificación , Pie Diabético/fisiopatología , Suplementos Dietéticos , Glutamina/administración & dosificación , Valeratos/administración & dosificación , Cicatrización de Heridas , Adulto , Anciano , Anciano de 80 o más Años , Índice Tobillo Braquial , Pie Diabético/dietoterapia , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: The objective of this study was to examine the effects of soy formulas with and without added soy fiber in children who developed diarrhea while receiving antibiotics. DESIGN: In a masked, randomized parallel study, older infants and toddlers were fed commercial soy formulas with or without added soy fiber for 10 days on occurrence of diarrhea during the administration of antibiotics. Subjects were stratified by feeding (formula versus cow's milk). The primary variables were duration of diarrhea, stool characteristics, and intake. Secondary variables were weight and spit-up. RESULTS: All 45 children who completed the 10-day study received >30% of their caloric intake from formula. Fiber intake from other foods did not differ between groups and averaged 0.5 g/day. Total median fiber intake of the group fed the formula with added fiber was 6.53 g/day. The mean duration of diarrhea was 25.1 +/- 5.2 hours for children fed the formula with added fiber and 51.6 +/- 10.7 hours for those fed the regular formula (P =.0013). CONCLUSION: The duration of antibiotic-induced diarrhea in children fed the soy formula with added soy fiber was significantly reduced.
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Antibacterianos/efectos adversos , Diarrea Infantil/inducido químicamente , Diarrea Infantil/dietoterapia , Fibras de la Dieta/uso terapéutico , Glycine max , Alimentos Infantiles , Ingestión de Energía , Femenino , Humanos , Lactante , Masculino , Evaluación de Resultado en la Atención de Salud , Vómitos/inducido químicamente , Vómitos/dietoterapia , Aumento de PesoRESUMEN
OBJECTIVE: At hospital discharge, preterm infants may have low body stores of nutrients, deficient bone mineralization, and an accumulated energy deficit. This double-blind, randomized study evaluated the growth of premature infants with birth weights <1800 g who were fed a 22 kcal/fl oz nutrient-enriched postdischarge formula (PDF) or a 20 kcal/fl oz term-infant formula (TF) from hospital discharge to 12 months' corrected age (CA). METHODS: Infants were randomized to PDF or TF a few days before hospital discharge with stratification by gender and birth weight (<1250 g or >/=1250 g). The formulas were fed to 12 months' CA. Growth was evaluated using analysis of variance controlling for site, feeding, gender, and birth weight group. Interaction effects were also assessed. Secondary analyses included a repeated measures analysis and growth modeling. RESULTS: One hundred twenty-five infants were randomized; 74 completed to 6 months' CA and 53 to 12 months' CA. PDF-fed infants weighed more than TF-fed infants at 1 and 2 months' CA, gained more weight from study day 1 to 1 and 2 months' CA, and were longer at 3 months' CA. There were significant interactions between feeding and birth weight group-among infants with birth weights <1250 g, those fed PDF weighed more at 6 months' CA, were longer at 6 months' CA, had larger head circumferences at term 1, 3, 6, and 12 months' CA, and gained more in head circumference from study day 1 to term and to 1 month CA. The repeated measures and growth modeling analyses confirmed the analysis of variance results. The PDF formula seemed to be of particular benefit for the growth of male infants. Infants fed the PDF consumed less formula and had higher protein intakes at several time points. Energy intakes, however, were not different. CONCLUSIONS: Growth was improved in preterm infants fed a nutrient-enriched postdischarge formula after hospital discharge to 12 months' CA. Beneficial effects were most evident among infants with birth weights <1250 g, particularly for head circumference measurements.
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Suplementos Dietéticos , Alimentos Infantiles , Fenómenos Fisiológicos Nutricionales del Lactante , Recien Nacido Prematuro/crecimiento & desarrollo , Cuidados Posteriores , Ingestión de Energía , Estudios de Seguimiento , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Resultado del TratamientoRESUMEN
OBJECTIVE: A prospective, double-blind, randomized, controlled trial was conducted to evaluate the growth and nutritional status of preterm infants receiving preterm human milk supplemented with a newly formulated powdered human milk fortifier (HMF), study fortifier (SF), or a powdered commercial HMF (CF). METHODS: Infants (n = 144) with a birth weight =1600 g and gestational age at birth of =33 weeks were enrolled and randomized before 21 days of life. Study day (SDAY) 1 was defined as the day full-strength fortification (4 packets/100 mL) began and the infant reached an intake of at least 100 mL/kg/day. Growth, biochemical indices of nutritional status, enteral intake, feeding tolerance, clinical histories, and morbidity were assessed serially. The primary outcome variable was weight gain (g/kg/day) from SDAYs 1 to 29 or hospital discharge, whichever came first. RESULTS: Infants fed human milk supplemented with SF consistently grew more rapidly from SDAYs 1 to 29 (or hospital discharge), regardless of whether the statistical analyses were performed on all subjects who were randomized into the study and reached SDAY 1 (intent-to-treat) or were limited to those able to adhere strictly to the feeding protocol of the study (subgroup). Using mean values adjusted for study site (least square [LS] means), the weight gain differences were 2.6 and 3.8 g/kg/day for the intent-to-treat and subgroup analyses, respectively. Likewise, the length-gain differences were.14 and.18 cm/week for the intent-to-treat and subgroup analyses, respectively. Infants in the SF group reached a weight of 1800 g at SDAY 18, and those in the CF group at SDAY 25. Mean alkaline phosphatase values among infants in the SF group were higher than for the CF infants (eg, LS means: 327 U/L vs 272 U/L, intent-to-treat analysis), likely reflecting the more rapid linear growth of the SF infants. Mean serum calcium values tended to be lower in the SF group in the intent-to-treat analysis and were significantly lower in the subgroup analysis (LS means: 10.3 mg/dL vs 11.2 mg/dL). Both fortifiers were generally well-tolerated, although an increased number of infants in the CF group exited the feeding protocol because of gastric residuals and abdominal distention. CONCLUSION: A new powdered HMF was shown to enhance the growth of preterm infants, compared with a commercially available powdered HMF in the United States.
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Suplementos Dietéticos , Recién Nacido de Bajo Peso , Recien Nacido Prematuro/crecimiento & desarrollo , Leche Humana , Antropometría , Método Doble Ciego , Estudios de Evaluación como Asunto , Humanos , Recién Nacido , Estado Nutricional , Estudios ProspectivosRESUMEN
OBJECTIVE: Perceived intolerance to infant formula is a frequently reported reason for formula switching. Formula intolerance may be related to perceived symptoms of constipation, fussiness, abdominal cramps, and excessive spit-up or vomit. Commercially available formulas differ from each other in processing and in sources and levels of protein, lipids, and micronutrients. These differences may affect tolerance. The objective of this article was to compare the tolerance of two commercially available powder infant formulas that differ in composition. Measures of tolerance in exclusively breastfed infants weaned to an infant formula and exclusively formula-fed infants were evaluated. METHODS: Two clinical studies were conducted. In study 1, 82 healthy, full-term infants who were exclusively breastfed at the time of enrollment were randomized at weaning to formula A (commercially available Similac With Iron Powder) or formula B (previously available Enfamil With Iron Powder). Parents completed daily records of tolerance during exclusive breast milk feeding, during the weaning period, and for a 2-week exclusive formula-feeding period. In study 2, 87 healthy, full-term infants who were exclusively formula-fed at the time of study enrollment (by 2 weeks of age) were fed a standard cow milk-based formula (previously commercially available Similac With Iron Powder) and then randomized to receive formula A or B for a 2-week period. Parents completed daily records of tolerance throughout the study. Formula A was a cow milk-based formula with a whey:casein ratio of 48:52 and a fat blend of 42% high-oleic safflower, 30% coconut, and 28% soy oils. Formula B was a cow milk-based formula with a whey:casein ratio of 60:40 and a fat blend of 45% palm olein, 20% soy, 20% coconut, and 15% high-oleic sunflower oils. Both formulas had lactose as the source of carbohydrate and contained 12 mg of iron per liter. Only formula A contained nucleotides at the time of the study. Measures of tolerance included volume of each formula feeding, occurrences of spit-up and/or vomit, and the color (yellow, green, brown, or black) and consistency (water, loose/mushy, soft, formed, or hard) of each stool. RESULTS: In both studies, volume of formula intake, weight gain, and incidence of spit-up or vomit did not differ between feeding groups. In study 1, stool frequency decreased significantly from the exclusive breast milk period to weaning. Stools also became firmer as infants moved from breast milk to weaning and to exclusive formula feeding. When formula was introduced into the diet, stools became less yellow and more green. Infants weaned to formula B had less frequent stools, fewer brown stools, and more yellow stools than did infants fed formula A. In both studies, infants fed formula B experienced significantly firmer stools than did those fed formula A. CONCLUSIONS: The present clinical studies indicate that the composition and/or processing of milk-based powder iron-fortified infant formulas affect stool characteristics experienced by infants. The inclusion of palm olein oil in formula B may be the reason for the observed differences in stool characteristics. Palm olein is used in infant formulas to provide palmitic acid at a level similar to that found in breast milk. However, palmitic acid from palm olein is arranged differently from that in breast milk triglyceride and is poorly absorbed. Unabsorbed palmitic acid tends to react with calcium to form insoluble soaps, and the level of these soaps is correlated with stool hardness. The pattern of softer stools and greater frequency of stooling associated with formula A is similar to the stool pattern in the exclusively breastfed infant. Thus, the use of formula A may ease the transition from breast milk to formula feeding and ameliorate parents' perception that constipation is associated with iron-fortified formula.