Semi-elemental versus polymeric formula for enteral nutrition in brain-injured critically ill patients: a randomized trial.

BACKGROUND: The properties of semi-elemental enteral nutrition might theoretically improve gastrointestinal tolerance in brain-injured patients, known to suffer gastroparesis. The purpose of this study was to compare the efficacy and tolerance of a semi-elemental versus a polymeric formula for enteral nutrition (EN) in brain-injured critically ill patients. METHODS: Prospective, randomized study including brain-injured adult patients [Glasgow Coma Scale (GCS) ≤ 8] with an expected duration of mechanical ventilation > 48 h. INTERVENTION: an enteral semi-elemental (SE group) or polymeric (P group) formula. EN was started within 36 h after admission to the intensive care unit and was delivered according to a standardized nurse-driven protocol. The primary endpoint was the percentage of patients who received both 60% of the daily energy goal at 3 days and 100% of the daily energy goal at 5 days after inclusion. Tolerance of EN was assessed by the rate of gastroparesis, vomiting and diarrhea. RESULTS: Respectively, 100 and 95 patients were analyzed in the SE and P groups: Age (57[44-65] versus 55[40-65] years) and GCS (6[3-7] versus 5[3-7]) did not differ between groups. The percentage of patients achieving the primary endpoint was similar (46% and 48%, respectively; relative risk (RR) [95% confidence interval (CI)] = 1.05 (0.78-1.42); p = 0.73). The mean daily energy intake was, respectively, 20.2 ± 6.3 versus 21.0 ± 6.5 kcal/kg/day (p = 0.42). Protein intakes were 1.3 ± 0.4 versus 1.1 ± 0.3 g/kg/day (p < 0.0001). Respectively, 18% versus 12% patients presented gastroparesis (p = 0.21), and 16% versus 8% patients suffered from diarrhea (p = 0.11). No patient presented vomiting in either group. CONCLUSION: Semi-elemental compared to polymeric formula did not improve daily energy intake or gastrointestinal tolerance of enteral nutrition. TRIAL REGISTRATION: EudraCT/ID-RCB 2012-A00078-35 (registered January 17, 2012).

Safety and efficacy of volume-based feeding in critically ill, mechanically ventilated adults using the 'Protein & Energy Requirements Fed for Every Critically ill patient every Time' (PERFECT) protocol: a before-and-after study.

BACKGROUND: Underfeeding in critical illness is common and associated with poor outcomes. According to large prospective hospital studies, volume-based feeding (VBF) safely and effectively improves energy and protein delivery to critically ill patients compared to traditional rate-based feeding (RBF) and might improve patient outcomes. A before-and-after study was designed to evaluate the safety, efficacy and clinical outcomes associated with VBF compared to RBF in a single intensive care unit (ICU). METHODS: The sample included consecutively admitted critically ill adults, mechanically ventilated for at least 72 h and fed enterally for a minimum of 48 h. The first cohort (n = 46) was fed using RBF, the second (n = 46) using VBF, and observed for 7 days, or until extubation or death. Statistical comparison of percentage feed volume, energy and protein delivered, plus indices of feed intolerance, were the primary outcomes of interest. Secondary observations included ventilation period, mortality, and length of ICU stay (LOICUS). RESULTS: Groups were comparable in baseline clinical and demographic characteristics and nutrition practices. Volume delivered to the VBF group increased significantly by 11.2% (p ≤ 0.001), energy by 13.4% (p ≤ 0.001) and protein by 8.4% (p = 0.02), compared to the RBF group. In the VBF group, patients meeting > 90% of energy requirements increased significantly from 47.8 to 84.8% (p ≤ 0.001); those meeting > 90% of protein requirements changed from 56.5 to 73.9% (p = 0.134). VBF did not increase symptoms of feed intolerance. Adjusted binomial logistic regression found each additional 1% of prescribed feed delivered decreased the odds of vomiting by 0.942 (5.8%), 95% CI [0.900-0.985], p = 0.010. No differences in mortality or LOICUS were identified. Kaplan-Meier found a significantly increased extubation rate in patients receiving > 90% of protein requirements compared to those meeting < 80%, (p = 0.006). Adjusted Cox regression found the daily probability of being extubated tripled in patients receiving > 90% of their protein needs compared to the group receiving < 80%, hazard ratio 3.473, p = 0.021, 95% CI [1.205-10.014]. CONCLUSION: VBF safely and effectively increased the delivery of energy and protein to critically ill patients. Increased protein delivery may improve extubation rate which has positive patient-centred and financial implications, warranting larger confirmatory trials. This investigation adds weight to the ICU literature supporting VBF, and the growing evidence which advocates for enhanced protein delivery to improve patient outcomes.

Indigenous food ingredients for complementary food formulations to combat infant malnutrition in Benin: a review.

This paper reviews indigenous Beninese food resources as potential ingredients for complementary infant foods with the aim to develop affordable formulations for low-income households in each agro-ecological zone of the country. Potential ingredients were selected on their documented nutritional value. The selected foods encompass 347 food resources, namely 297 plant products from home gardens or collected from natural vegetation and 50 animals, either domesticated or from the wild. The compiled data reveal that the distribution of the available food resources was unbalanced between agro-ecological zones. Only a few animal ingredients are obtainable in northern Benin. Most resources are seasonal, but their availability may be extended. A high variation was observed in energy and nutrient contents. Antinutritional factors were identified in some resources, but processing techniques were reported to reduce their presence in meals. In general, ingredients from local tree foods (Adansonia digitata, Parkia biglobosa) were adequate as sources of nutrients for complementary infant foods. Based on this review, local foods for the development of complementary food formulas for Beninese infants and children may be selected for each agro-ecological zone. The approach used is exemplary for other sub-Saharan African countries in need of complementary infant foods. © 2017 Society of Chemical Industry.

The effect of an elemental diet on oral mucositis of esophageal cancer patients treated with DCF chemotherapy: a multi-center prospective feasibility study (EPOC study).

PURPOSE: Oral mucositis (OM) is one of the most uncomfortable adverse events experienced by cancer patients undergoing chemotherapy. Previous reports have revealed that the oral administration of an elemental diet (ED) may prevent OM. However, the incidence of OM has not been accurately determined by specialized diagnostic methods and the effects of an ED on OM remain unclear. We investigated the dose that could feasibly be administered and its effects with regard to the suppression of OM in esophageal cancer patients undergoing chemotherapy. METHODS: We performed a prospective multi-center feasibility study of the administration of an ED (160 g/day) with 2 cycles of docetaxel/cisplatin/5-FU (DCF) chemotherapy. We assessed compliance to the ED for 49 days and the incidence of OM according to the amount of the ED that was orally administered. The incidence of OM was graded by a dental specialist who was experienced in dental oncology using a central OM review system. RESULTS: Fourteen of 20 patients (70%) were able to complete the orally administered ED (160 g/day) during the course of chemotherapy. Three patients (15%) could not take the ED orally for 9, 14, and 21 days, respectively, while 1 patient (5%) took the ED orally at an average dose of 80 g/day for 35 days. The remaining 2 patients (10%) could not take the 80 g/day dose for 11 and 12 days, respectively. The incidence of grade ≥ 2 OM in the ED completion group (15.4%, 2 of 13 patients) was significantly lower than that in the non-completion group (66.7%, 4 of 6 patients) (p = 0.046). CONCLUSIONS: An ED might be a one of the test treatment to reduce the incidence of OM in esophageal cancer patients treated with DCF and should be evaluated in further randomized study. CLINICAL TRIAL: The date of submission: Dec 08th, 2017.

Ready-to-Use Supplementary Foods and Ready-to-Use Therapeutic Foods: Developing Product Standards.

The purpose of this commentary is to describe the current regulatory environment for the multitude of ready-to-use supplementary foods and ready-to-use therapeutic foods used in international feeding programs for undernourished and malnourished children. A perspective on the role of standards, their desirable scope, benefits and limitations as well as possible future developments of products in these categories also is provided.

Determination of fortified and endogenous folates in food-based Standard Reference Materials by liquid chromatography-tandem mass spectrometry.

The National Institute of Standards and Technology (NIST) is developing a wide variety of Standard Reference Materials (SRMs) to support measurements of vitamins and other nutrients in foods. Previously, NIST has provided SRMs with values assigned for the folate vitamer, folic acid (pteroylglutamic acid), which is fortified in several foods due to its role in prevention of neural tube defects. In order to expand the number of food-based SRMs with values assigned for folic acid, as well as additional endogenous folates, NIST has developed methods that include trienzyme digestion and isotope-dilution liquid chromatography-tandem mass spectrometric (LC-MS/MS) analysis. Sample preparation was optimized for each individual food type, but all samples were analyzed under the same LC-MS/MS conditions. The application of these methods resulted in folic acid values for SRM 1849a Infant/Adult Nutritional Formula and SRM 3233 Fortified Breakfast Cereal of (2.33 ± 0.06) µg/g and (16.0 ± 0.7) µg/g, respectively. In addition, the endogenous folate vitamer 5-methlytetrahydrofolate (5-MTHF) was detected and quantified in SRM 1849a Infant/Adult Nutritional Formula, candidate SRM 1549a Whole Milk Powder, and candidate SRM 1845a Whole Egg Powder, resulting in values of (0.0839 ± 0.0071) µg/g, (0.211 ± 0.014) µg/g, and (0.838 ± 0.044) µg/g, respectively. SRM 1849a Infant/Adult Nutritional Formula is the first food-based NIST SRM to possess a reference value for 5-MTHF and the first certified reference material to have an assigned 5-MTHF value based on LC-MS/MS. The values obtained for folic acid and 5-MTHF by LC-MS/MS will be incorporated into the final value assignments for all these food-based SRMs.

Characterization of NIST food-matrix Standard Reference Materials for their vitamin C content.

The vitamin C concentrations in three food-matrix Standard Reference Materials (SRMs) from the National Institute of Standards and Technology (NIST) have been determined by liquid chromatography (LC) with absorbance detection. These materials (SRM 1549a Whole Milk Powder, SRM 1849a Infant/Adult Nutritional Formula, and SRM 3233 Fortified Breakfast Cereal) have been characterized to support analytical measurements made by food processors that are required to provide information about their products' vitamin C content on the labels of products distributed in the United States. The SRMs are primarily intended for use in validating analytical methods for the determination of selected vitamins, elements, fatty acids, and other nutrients in these materials and in similar matrixes. They can also be used for quality assurance in the characterization of test samples or in-house control materials, and for establishing measurement traceability. Within-day precision of the LC method used to measure vitamin C in the food-matrix SRMs characterized in this study ranged from 2.7% to 6.5%.

Specially formulated foods for treating children with moderate acute malnutrition in low- and middle-income countries.

BACKGROUND: Moderate acute malnutrition, also called moderate wasting, affects around 10% of children under five years of age in low- and middle-income countries. There are different approaches to addressing malnutrition with prepared foods in these settings; for example, providing lipid-based nutrient supplements or blended foods, either a full daily dose or in a low dose as a complement to the usual diet. There is no definitive consensus on the most effective way to treat children with moderate acute malnutrition. OBJECTIVES: To evaluate the safety and effectiveness of different types of specially formulated foods for children with moderate acute malnutrition in low- and middle-income countries, and to assess whether foods complying or not complying with specific nutritional compositions, such as the WHO technical specifications, are safe and effective. SEARCH METHODS: In October 2012, we searched CENTRAL, MEDLINE, LILACS, CINAHL, BIBLIOMAP, POPLINE, ZETOC, ICTRP, mRCT, and ClinicalTrials.gov. In August 2012, we searched Embase. We also searched the reference lists of relevant papers and contacted nutrition-related organisations and researchers in this field.     SELECTION CRITERIA: We planned to included any relevant randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before-and-after studies (CBAs), and interrupted time series (ITS) that evaluated specially formulated foods for the treatment of moderate acute malnutrition in children aged between six months and five years in low- and middle-income countries. DATA COLLECTION AND ANALYSIS: Two authors assessed trial eligibility and risk of bias, and extracted and analysed the data. We summarised dichotomous outcomes using risk ratios (RR) and continuous outcomes using mean differences (MD) with 95% confidence intervals (CI). Where appropriate, we combined data in meta-analyses using the random-effects model and assessed heterogeneity. The quality of evidence was assessed using GRADE methods. MAIN RESULTS: Eight randomised controlled trials, enrolling 10,037 children, met our inclusion criteria. Seven of the trials were conducted in Africa. In general, the included studies were at a low risk of bias. There may have been a risk of performance bias as trial participants were aware which intervention group they were in, but we did not consider this likely to have biased the outcome measurement. We were unable to assess the risk of reporting bias in half of the trials and two trials were at high risk of attrition bias. Any specially formulated food versus standard care - the provision of food increased the recovery rate by 29% (RR 1.29, 95% CI 1.20 to 1.38; 2152 children, two trials; moderate quality evidence), decreased the number dropping out by 70% (RR 0.30, 95% CI 0.22 to 0.39; 1974 children, one trial; moderate quality evidence), and improved weight-for-height (MD 0.20 z-score, 95% CI 0.03 to 0.37; 1546 children, two trials; moderate quality evidence). The reduction in mortality did not reach statistical significance (RR 0.44; 95% CI 0.14 to 1.36; 1974 children, one trial; low quality evidence). Lipid-based nutrient supplements versus any blended foods (dry food mixtures, without high lipid content), at full doses - there was no significant difference in mortality (RR 0.93, 95% CI 0.54 to 1.62; 6367 children, five trials; moderate quality evidence), progression to severe malnutrition (RR 0.88, 95% CI 0.72 to 1.07; 4537 children, three trials; high quality evidence), or the number of dropouts from the nutritional programme (RR 1.14, 95% CI 0.62 to 2.11; 5107 children, four trials; moderate quality evidence). However, lipid-based nutrient supplements significantly increased the number of children recovered (RR 1.10, 95% CI 1.04 to 1.16; 6367 children, five trials; moderate quality evidence), and decreased the number of non-recovering children (RR 0.53, 95% CI 0.40 to 0.69; 4537 children, three trials; high quality evidence). LNS also improved weight gain, weight-for-height, and mid-upper arm circumference, although for these outcomes, the improvement was modest (moderate quality evidence). One trial observed more children with vomiting in the lipid-based nutrient supplements group compared to those receiving blended food (RR 1.43, 95% CI 1.11 to 1.85; 2712 children, one trial; low quality evidence). Foods at complementary doses - no firm conclusion could be drawn on the comparisons between LNS at complementary dose and blended foods at complementary or full dose (low quality evidence). Lipid-based nutrient supplements versus specific types of blended foods - a recently developed enriched blended food (CSB++) resulted in similar outcomes to LNS (4758 children, three trials; moderate to high quality evidence). Different types of blended foods - in one trial, CSB++ did not show any significant benefit over locally made blended food, for example, Misola, in number who recovered, number who died, or weight gain (moderate to high quality evidence). Improved adequacy of home diet - no study evaluated the impact of improving adequacy of local diet, such as local foods prepared at home according to a given recipe or of home processing of local foods (soaking, germination, malting, fermentation) in order to increase their nutritional content. AUTHORS' CONCLUSIONS: In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with MAM. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. Most of the research so far has focused on industrialised foods, and on short-term outcomes of MAM. There are no studies evaluating interventions to improve the quality of the home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent.

Economical and financial analysis of lamb finishing fed with diets formulated according to the NRC (1985) and the NRC (2007).

This study compares both versions of the nutritional requirement system determined by the National Research Council (NRC) version 1985 (NRC85) and NRC version 2007 (NRC07), for finishing lambs in feedlots. Nineteen crossbred lambs were divided in four groups representing four experimental treatments: one diet according to NRC85 and three diets according to NRC07. The diets recommended by NRC07 considers crude protein intake relative to ruminal undegradable protein at 20, 40, and 60 % levels (NRC07/20, NRC07/40, and NRC07/60). Diets were composed of Brazilian semi-arid native grass silage, soybean meal, corn, annatto byproduct, and limestone. Purchases and sales of lambs were done according to average market prices in Brazil. The economic indicators considered pointed that all treatments were viable but NRC07/20 and NRC07/60 were more profitable with similar net present values (NPVs) and internal return rates (IRRs). NRC07/20 was the best option showing an IRR of 17.20 % and a payback period (PP) of 5.07 considering a fixed annual interest rate of 6 %. Sensitivity analysis considering a 10 % raise in variable costs showed negative NPVs, IRRs inferior to the opportunity cost rates adopted and PPs that exceeded the planning horizon of 7 years for both NRC85 and NRC07/40.

[Immuno-nutrition in intensive care and emergency surgery].

The aim of the study is the improvement of nutritional support by immuno nutrition of patients, who are in critical conditions. The data on the impact of immuno active mixes (on the example of the mixture of Impact) on the immune and inflammatory response. In this, the number of postoperative infectious complications have been reliably decreased, the duration of the stay in the Department of R&IT and the hospital has been dicresed in whole, the cost of treatment in comparison with the use of standard schemes of patients with surgical and oncological profile has been significantly reduced.

[Formulation and elaboration of low-energy and high fiber-containing brownies]. / Formulación y elaboración de pastelillos tipo brownies con más fibra y menos calorías que los convencionales.

Different formulations for chocolate pastries making (brownies) were prepared by substituting 15, 20, and 25% of the wheat flour by inulin. The batter characteristics of each formulation were evaluated and the batters were baked at 175 degrees C for 15 min. After baking, the brownies were allowed to cool, put into crystal polystyrene trays, and their texture after 1, 3, 7, and 15 days of storage at room temperature (25 degrees C) and 65% of relative humidity, was evaluated. Based on the evaluations of batter characteristics and brownies textural properties during storage, the formulation containing 20% of inulin was the best. Proximate analysis was determined, and total, soluble and insoluble dietary fiber were quantified for brownies control and 20% inulin ones, as well as commercial brownies. The brownies containing 20% inulin showed lower firmness, gumminess, and masticability than the control and higher protein and lower fat content (6,3 vs 26,3%) and caloric value (331,4 vs 467.9 kcal/100 g) in comparison to the commercial brownies. The brownie with 20% inulin had twice the total dietary fiber and 22 times more soluble fiber than the brownie control. The acceptability of the brownie with 20% inulin was similar to that of the control. The incorporation of inulin in the production of brownies allowed to reduce the caloric value and to increase the soluble fiber content without adverse effects in texture of the pastries.

[Depyrogenation test regarding inox and glass containers in the preparation of parenteral nutrition mixtures]. / Test de dépyrogénation des conteneurs en inox et en verre pour la préparation des mélanges pour nutrition parentérale.

INTRODUCTION: The preparation of parenteral nutrition mixture (PNM) in an open chamber requires the use of intermediate containers sterile and non-pyrogenic. A sterilization of containers by moist heat in large autoclaves is the suitable method. However, sterilization by moist heat is not a depyrogenation method. In our study, we report the validation of a sterilization and depyrogenation method for containers by dry heat using a convection oven. MATERIALS AND METHODS: Sterilization and depyrogenation of material by dry heat have been audited by the reduction of at least three logarithms of original endotoxin rate. The containers were initially artificially contaminated with a suspension of endotoxin for 16 hours. Contaminated containers were placed in an oven with revolving heat at 250 °C for 1 hour. After treatment with dry heat, the residual endotoxin levels in the containers were determined by a kinetic chromogenic method. RESULTS: After treatment with dry heat, the average log reductions of endotoxin levels were respectively, for glass and steel containers, 4.78 ± 0.07 and 4.87 ± 0.03. DISCUSSION AND CONCLUSION: The present validation study confirms the effectiveness of treatment with dry heat for sterilization and depyrogenation of glass and steel containers. This method of sterilization and depyrogenation meets the microbiological quality requirements for the preparation of MNP.

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.

BACKGROUND: Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. METHODS: All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. RESULTS: Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. CONCLUSIONS: This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.

Effect of Artificial Diet on Immature Stage of the Great Eggfly, Hypolimnas bolina (Lepidoptera: Nymphalidae).

<b>Background and Objective:</b> One of the Nymphalidae butterfly species found in West Sumatra in <i>Hypolimnas bolina</i>. Currently, research on the artificial diet for the Nymphalidae butterfly is relatively rare in Padang, West Sumatra. The objectives of this study were to analyze the preferences of <i>H. bolina</i> larvae, duration of the immature stage and mortality of <i>H. bolina</i> in artificial diet treatment. <b>Materials and Methods:</b> Some biological aspects of <i>H. bolina</i> in corresponding to artificial diet and its effect were investigated in the laboratory. <b>Results:</b> The result showed that there was no significant difference in the frequency of visits of the larvae in the two diet treatments namely natural (<i>Laportea interrupta</i> leaves) and artificial diets (Sig = 0.289, p>0.05) but the duration of the visit of <i>H. bolina</i> larvae was significantly different (Sig = 0.000, p<0.05). The visit duration of the immature stage of <i>H. bolina </i>was significantly different, except the prepupa and pupal stage. There was no mortality of instar larvae and prepupa stage observed in both of the two-diet treatments. However, the mortality of pupae in an artificial diet was 4%. Of the total of 24 individual larvae fed with artificial diet, all of them successfully emerged, consisted of 12 males and 12 females but there was one male with abnormal wings. The average living period in the artificial diet of imago was 14.82 days for males and 16.77 days for a female. The average larval weight was no significant difference (Sig = 0.981, p>0.05) but the average pupal weight of the natural diet was slightly higher than the artificial diet. <b>Conclusion:</b> The formulation of an artificial diet is suitable for <i>H. bolina</i> larvae based on the results of immature mortality and adult emergences. Therefore, the formulation of an artificial diet is suitable for <i>H. bolina</i> with its composition almost similar to <i>L. interrupta</i> leaves (natural diet).

The role of the Codex Alimentarius process in support of new products to enhance the nutritional health of infants and young children.

The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. Among other functions, it is responsible for setting international standards for safety and hygiene. Codex food standards and guidelines directed at foods produced primarily for young infants and children have important implications for maintaining nutritional status and health, especially given the positioning of these products as components of established World Health Organization (WHO)/UNICEF-recommended feeding strategies. Recently, new products targeted at this age group (e.g., lipid-based nutrient supplements and micronutrient powders) have been produced and used, but these are not totally covered under existing Codex guidelines or standards. The objective of this paper is to review the role of the Codex process and specifically to suggest revisions to existing Codex guidelines on formulated complementary foods (Guidelines for Formulated Supplementary Foods for Older Infants and Young Children, CAC/GL 08-1991) to encompass this new category of fortified complementary foods and home fortificants. In reviewing the existing guidelines, potential areas for revision included the sections on the recommended nutrients in these foods and their intended use. Updating the Codex guidelines provides the opportunity to encourage production and use of new products for children and help ensure that such foods, when used as directed, do not interfere with breastfeeding. The revised guidelines would help governments develop national regulations covering all forms of formulated complementary foods. They would also lessen impediments to international trade by providing clear guidance for foods used in feeding programs and for young children, particularly in developing countries.

[Experimental rationale for approaches to the development and evaluation of new functional foodstuffs].

This comprehensive experimental study had the objective to determine the optimum ratio of calcium and vitamin D used as additives in food compositions and provide an experimentally-based rationale for the use of new functional dairy products and evaluation of their nutritional value. Experimental medico-biological assessment was conducted using growing male Wistar rats by balance and biochemical methods. It was shown that the calcium/vitamin D ratio in foodstuffs determines their functional efficiency. High nutritive and biological value was documented for some new cottage cheese products rich in calcium (240 mg%) and vitamin D (1 mg%). Results of the study were used to develop guidelines for the enrichment of various food compositions with calcium and vitamin D and substantiate methods for the assessment of their real functional effectiveness.

Design, quality, safety and efficacy of extensively hydrolyzed formula for management of cow's milk protein allergy: What are the challenges?

Cow's milk protein allergy (CMPA) is one of the most common food allergies in infancy. Clinical food allergy guidelines recommend an extensively hydrolyzed formula (EHF) as the first-line treatment in nonbreastfed infants with CMPA. Designing and commercializing EHF poses both technical and regulatory challenges. Each manufacturing step, from sourcing of raw materials to release of the final product, needs to be managed in accordance with comprehensive quality systems. To avoid cross-contamination via externally sourced ingredients, suppliers should be carefully selected based on quality requirements. Strict zoning of the manufacturing areas according to contamination risk and air flow control are effective strategies to prevent accidental allergen contamination. Furthermore, dedicated manufacturing lines for hypoallergenic products are used to prevent potential cross-contamination from other products produced on the same line. The enzymatic hydrolysis, heat treatment and ultrafiltration used are specific to each manufacturer. Consequently, EHF are a heterogenous group of products with differences in the molecular weight profile of peptides, content of residual immunogenic cow's milk allergens, and residual in-vitro allergenicity. These differences are likely to affect clinical efficacy and safety. As not all commercialized EHF products have undergone formal testing in the laboratory and clinical trials, there is a need to develop guidelines for minimum technical and regulatory requirements for EHF products, including validated assays for ongoing quality control. Clinical trials assessing new EHF products for their hypoallergenicity and ability to support normal growth remain the definitive proof of efficacy and safety in infants and young children with CMPA.

Achieving Protein Targets in the ICU Using a Specialized High-Protein Enteral Formula: A Quality Improvement Project.

BACKGROUND: To meet protein needs in critical illness (CI), guidelines suggest ≥1.2-2.5 g protein/kg/d; however, most intensive care unit (ICU) patients receive ≤0.7 g/kg/d. Higher protein enteral nutrition (EN) formulas may be part of the solution to provide prescribed protein. Our objective was to demonstrate that an EN formula with 37% protein can deliver ≥80% of prescribed protein, without overfeeding calories within the first 5 days of feeding and to describe ICU clinicians' experience. METHODS: This quality improvement (QI) project included patients requiring exclusive EN for up to 5 days from 6 Canadian ICUs. Rationale for choosing formula, patient's BMI (kg/m2 ), nutrition targets, daily protein and energy delivered, feeding interruptions, and general tolerance were recorded. RESULTS: Forty-four of 49 patients received the formula ≥2 days. Average protein prescribed was 137.5 g/d (82.5-200) or 1.9 g/kg/d (1.5-2.5). Average protein delivered was 116.9 g/d (33.5-180) or 1.6 g/kg/d (0.4-2.4). Seventy-five percent to 83% of patients received ≥80% prescribed protein on days 2-5. Average energy prescribed was 1638.6 kcal/d (990-2500) or 17.8 kcal/kg (11-26). Average energy delivered was 1523.9 kcal/d (693.0-2557.5) or 17.3 kcal/kg/d (1.35-64.7). The formula was well tolerated with no gastrointestinal symptoms reported in 38 (86%) patients. The most common reasons to prescribe the formula were obesity and use of fat-based medications. CONCLUSIONS: We demonstrated in a QI study that a high-protein EN formula was tolerated in a small, heterogeneous group of ICU patients and effective in meeting protein targets without overfeeding.

Strategies to manage gastrointestinal symptoms complicating enteral feeding.

Diarrhea and abdominal distension are common complications associated with enteral feeding. Often the cause is unknown, the enteral formula is blamed and changes to the mode of delivery or formula are instituted. However, the evidence base for many strategies used is limited. Altering the osmolality and temperature of the formula and/or the rate of infusion are commonly practiced but evidence for their benefit is largely anecdotal. Preventing microbial contamination of the feed is important and clear guidelines exist to achieve this. The formulation itself can be modified. While the addition of fiber is well supported theoretically, outcome data are less convincing. Avoidance of osmotically active, poorly absorbed short-chain carbohydrates in the formula (often used as the major carbohydrate source) is a new tactic to minimize diarrhea. It has compelling theoretical support, but requires further investigation. A methodical clinical approach to gastrointestinal complications of enteral feeding is warranted and an algorithm for management is proposed.

Glycemic control in patients with type 2 diabetes mellitus with a disease-specific enteral formula: stage II of a randomized, controlled multicenter trial.

BACKGROUND: Stage I of a preplanned 2-stage study has provided good evidence for improved glycemic control with a disease-specific enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), fish oil, chromium, and antioxidants in insulin-treated type 2 diabetes. The study was continued with stage II to give confirmatory proof of these beneficial effects. METHODS: 105 patients with HbA1C>or=7.0% and/or fasting blood glucose (FG)>6.7 mmol/L (>120 mg/dL) requiring enteral tube feeding due to neurological dysphagia received 113 kJ (27 kcal)/kg body weight of either test formula (Diben) or an isoenergetic, isonitrogenous standard formula (control) for up to 84 days. Total insulin (TI) requirements, FG, and afternoon blood glucose (AG) were assessed daily. HbA1C and safety criteria were evaluated on days 1, 28, 56, and 84. RESULTS: 55 patients completed the study; on day 84, median changes from baseline (data as available, test vs control) were the following: TI, -8.0 vs +2.0 IU; FG, -2.17 vs -0.67 mmol/L (-39.0 vs -12.1 mg/dL); HbA(1C), -1.30% vs -1.20%; AG, -2.36 vs -0.49 mmol/L (-42.5 vs -8.9 mg/dL). The number of relevant hypoglycemic episodes (FG<3.33 mmol/L<60 mg/dL) was 1 vs 5. Feeding tolerance was comparable in both groups. CONCLUSIONS: Long-term tube feeding with a disease-specific enteral formula was safe and well tolerated in type 2 diabetic patients with neurological disorders. When compared with a standard diet, TI requirement decreased significantly with less hypoglycemia whereas FG and AG were significantly lowered, resulting in improved glycemic control.