Specialized High�Protein Oral Nutrition Supplement Improves Home Nutrient Intake of Malnourished Older Adults Without Decreasing Usual Food Intake

Background: Reduced nutrient intake is common in patients after hospitalization, contributing to increased risk for readmissionand mortality. Oral nutrition supplements can improve nutrition status and clinical outcomes, but intake of food is prioritized byclinicians. This study examines the impact of a high-protein oral nutrition supplement (S-ONS) on nutrient intake post discharge. Methods: In a subset of patients (14 S-ONS and 16 placebo) from the NOURISH (Nutrition effect On Unplanned ReadmIssionsand Survival in Hospitalized patients) trial, 24-hour dietary recalls were conducted on 3 randomly selected days during the weeksof 30, 60, and 90 days post discharge. Nutrient intake was estimated using Nutrition Data System for Research software. Adequateenergy and protein intake were dened as 30 kcal/kg/d and 1.2 g/kg/d, respectively. Dietary Reference Intakes (DRIs) were usedfor other nutrients. Results: Less than half of patients met the requirements for energy, protein, and 12 micronutrients from foodintake alone during the study. Energy and protein intakes from food were not diminished relative to placebo. Considering nutrientintake from both food and S-ONS, 50% and 71% of patients receiving S-ONSs met energy and protein goals respectively at 90 days(compared with 29% and 36%, in the placebo group), and 100% met the DRI for total carbohydrate, iron, phosphorus, copper,selenium, thiamin, and riboavin at all time points, all of which were consumed at higher amounts vs placebo. Conclusion: Threemonths of S-ONS consumption increases intake of numerous nutrients without decreasing nutrient intake from food in oldermalnourished adults post discharge

Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial

SummaryBackgroundHospitalized, malnourished older adults have a high risk of readmission and mortality.ObjectiveEvaluation of a high-protein oral nutritional supplement (HP-HMB) containing beta-hydroxy-beta-methylbutyrate on postdischarge outcomes of nonelective readmission and mortality in malnourished, hospitalized older adults.DesignMulticenter, randomized, placebo-controlled, double-blind trial.SettingInpatient and posthospital discharge.PatientsOlder (≥65 years), malnourished (Subjective Global Assessment [SGA] class B or C) adults hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.InterventionsStandard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day.MeasurementsPrimary composite endpoint was 90-day postdischarge incidence of death or nonelective readmission. Other endpoints included 30- and 60-day postdischarge incidence of death or readmission, length of stay (LOS), SGA class, body weight, and activities of daily living (ADL).ResultsThe primary composite endpoint was similar between HP-HMB (26.8%) and placebo (31.1%). No between-group differences were observed for 90-day readmission rate, but 90-day mortality was significantly lower with HP-HMB relative to placebo (4.8% vs. 9.7%; relative risk 0.49, 95% confidence interval [CI], 0.27 to 0.90; p = 0.018). The number-needed-to-treat to prevent 1 death was 20.3 (95% CI: 10.9, 121.4). Compared with placebo, HP-HMB resulted in improved odds of better nutritional status (SGA class, OR, 2.04, 95% CI: 1.28, 3.25, p = 0.009) at day 90, and an increase in body weight at day 30 (p = 0.035). LOS and ADL were similar between treatments.LimitationsLimited generalizability; patients represent a selected hospitalized population.ConclusionsAlthough no effects were observed for the primary composite endpoint, compared with placebo HP-HMB decreased mortality and improved indices of nutritional status during the 90-day observation period.Clinical trial registrationwww.ClinicalTrials.gov NCT01626742

Growth, Tolerance, and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula with Added 2′-FL Fucosyllactose (2′-FL) Human Milk Oligosaccharide

Background: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2′-FL in an intended use population of infants. Methods: A non-randomized, single-group, multicenter study was conducted. Infants (0–60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study. Results: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078). Conclusions: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population

Comparison of Growth of Healthy Term Infants Fed Extensively Hydrolyzed Protein- and Amino Acid-Based Infant Formulas

The aim of this narrative review was to assess published growth data for healthy, term, infants consuming extensively hydrolyzed protein-based (EHF), or amino acid-based formulas (AAF). These data may be of use to clinicians managing infants with medical conditions consuming these products. A search was conducted using key terms: amino acid-based, hydrolysate, hydrolyzed, hydrolysed, infant formula, infant formulae or formulas, baby formula, or formulae or formulas, infant, infants, infantile, and growth. Seven controlled, randomized, prospective growth trials of healthy term infants fed EHFs or AAFs at similar time points during the first four months of age met these and other criteria, including that the trial was published in a peer-reviewed journal, subjects were enrolled by ≤14 days of age and were exclusively formula-fed at entry and throughout the duration of the trial, and infants were assessed at regular intervals with weight measures available ideally at 14 days, one, two, three, and four months of age. Results suggested that healthy infants receiving commonly available EHFs and AAFs do not appear to experience accelerated growth as reported for infants fed many standard formulas. Differences in growth patterns were observed with some formulas supporting normative growth patterns during the first four months but others appearing to support markedly lower growth patterns. These observations should be confirmed in well-designed prospective randomized trials. Until that time, it is recommended that EHFs and AAFs be chosen carefully with individual patient needs considered

Growth, Tolerance, and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula with Added 2′-FL Fucosyllactose (2′-FL) Human Milk Oligosaccharide

Background: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2′-FL in an intended use population of infants. Methods: A non-randomized, single-group, multicenter study was conducted. Infants (0–60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study. Results: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078). Conclusions: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population

Review of the Clinical Experiences of Feeding Infants Formula Containing the Human Milk Oligosaccharide 2′-Fucosyllactose

Human milk oligosaccharides (HMOs) are the third most abundant solid component in human milk after lactose and lipids. Preclinical research has demonstrated that HMOs and specifically 2′-fucosyllactose (2′-FL) are more than a prebiotic and have multiple functions, including immune, gut, and cognition benefits. Previously, human milk has been the only source for significant levels of HMOs. The most abundant HMO in most mothers’ breast milk is 2′-FL. Recently, 2′-FL has been synthesized and shown to be structurally identical to the 2′-FL found in human milk. 2′-FL HMO is now available in some commercial infant formulas. The purpose of this narrative review was to summarize the clinical experiences of feeding infant formula supplemented with the HMO, 2′-FL. Most of these studies investigated standard intact milk protein-based infant formulas containing 2′-FL, and one evaluated a partially hydrolyzed whey-based formula. Collectively, these clinical experiences demonstrated that 2′-FL being added to infant formula was safe, well-tolerated, and absorbed and excreted with similar efficiency to 2′-FL in human milk. Further, infants that were fed formula with 2′-FL had immune benefits, fewer parent-reported respiratory infections, and improved symptoms of formula intolerance. Ultimately, infant formula with 2′-FL supports immune and gut health and is closer compositionally and functionally to human milk

Evaluation of a free amino acid–based formula in infants with presumptive food protein–induced proctocolitis

Objective: Food protein–induced proctocolitis usually occurs early in life and is characterized by blood-streaked stools and pain during defecation in an otherwise healthy infant. While many infants with food protein–induced proctocolitis respond well to a casein hydrolysate formula, some require an amino acid–based formula. The objective of the study was to measure the change in physician-rated symptom score from enrollment to study completion in infants with presumptive food protein–induced proctocolitis fed with a specific amino acid-based formula. Methods: In this study, infants ≤6 months of age diagnosed with presumptive food protein–induced proctocolitis received an amino acid-based formula for 42 days. Intake, stool patterns, weight, stool occult blood, and questionnaires assessing infant feeding and stool patterns and parental formula satisfaction were collected. Results: The full analysis set included 43 infants. The mean age at enrollment was 59 ± 5 days. A significant improvement was observed from enrollment to exit in physician-rated symptom score (9.1 ± 0.5 to 4.8 ± 0.5, p < 0.0001), the number of infants with occult blood in stool, and weight-for-age Z-scores during the study. Parental satisfaction with the formula was high. Conclusion: The results confirm that the amino acid-based formula studied is efficacious for managing symptoms of presumptive food protein–induced proctocolitis

Specialized High-Protein Oral Nutrition Supplement Improves Home Nutrient Intake of Malnourished Older Adults Without Decreasing Usual Food Intake

Background: Reduced nutrient intake is common in patients after hospitalization, contributing to increased risk for readmissionand mortality. Oral nutrition supplements can improve nutrition status and clinical outcomes, but intake of food is prioritized byclinicians. This study examines the impact of a high-protein oral nutrition supplement (S-ONS) on nutrient intake post discharge. Methods: In a subset of patients (14 S-ONS and 16 placebo) from the NOURISH (Nutrition effect On Unplanned ReadmIssionsand Survival in Hospitalized patients) trial, 24-hour dietary recalls were conducted on 3 randomly selected days during the weeksof 30, 60, and 90 days post discharge. Nutrient intake was estimated using Nutrition Data System for Research software. Adequateenergy and protein intake were dened as 30 kcal/kg/d and 1.2 g/kg/d, respectively. Dietary Reference Intakes (DRIs) were usedfor other nutrients. Results: Less than half of patients met the requirements for energy, protein, and 12 micronutrients from foodintake alone during the study. Energy and protein intakes from food were not diminished relative to placebo. Considering nutrientintake from both food and S-ONS, 50% and 71% of patients receiving S-ONSs met energy and protein goals respectively at 90 days(compared with 29% and 36%, in the placebo group), and 100% met the DRI for total carbohydrate, iron, phosphorus, copper,selenium, thiamin, and riboavin at all time points, all of which were consumed at higher amounts vs placebo. Conclusion: Threemonths of S-ONS consumption increases intake of numerous nutrients without decreasing nutrient intake from food in oldermalnourished adults post discharge

Specialized High-Protein Oral Nutrition Supplement Improves Home Nutrient Intake of Malnourished Older Adults Without Decreasing Usual Food Intake

Background: Reduced nutrient intake is common in patients after hospitalization, contributing to increased risk for readmissionand mortality. Oral nutrition supplements can improve nutrition status and clinical outcomes, but intake of food is prioritized byclinicians. This study examines the impact of a high-protein oral nutrition supplement (S-ONS) on nutrient intake post discharge. Methods: In a subset of patients (14 S-ONS and 16 placebo) from the NOURISH (Nutrition effect On Unplanned ReadmIssionsand Survival in Hospitalized patients) trial, 24-hour dietary recalls were conducted on 3 randomly selected days during the weeksof 30, 60, and 90 days post discharge. Nutrient intake was estimated using Nutrition Data System for Research software. Adequateenergy and protein intake were de?ned as 30 kcal/kg/d and 1.2 g/kg/d, respectively. Dietary Reference Intakes (DRIs) were usedfor other nutrients. Results: Less than half of patients met the requirements for energy, protein, and 12 micronutrients from foodintake alone during the study. Energy and protein intakes from food were not diminished relative to placebo. Considering nutrientintake from both food and S-ONS, 50% and 71% of patients receiving S-ONSs met energy and protein goals respectively at 90 days(compared with 29% and 36%, in the placebo group), and 100% met the DRI for total carbohydrate, iron, phosphorus, copper,selenium, thiamin, and ribo?avin at all time points, all of which were consumed at higher amounts vs placebo. Conclusion: Threemonths of S-ONS consumption increases intake of numerous nutrients without decreasing nutrient intake from food in oldermalnourished adults post discharge