Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone.

BACKGROUND: Moderate acute malnutrition (MAM) affects 33 million children annually. Investments in formulations of corn-soy blended flours and lipid-based nutrient supplements have effectively improved MAM recovery rates. Information costs and cost-effectiveness differences are still needed. OBJECTIVES: We assessed recovery and sustained recovery rates of MAM children receiving a supplementary food: ready-to-use supplementary food (RUSF), corn soy whey blend with fortified vegetable oil (CSWB w/oil), or Super Cereal Plus with amylase (SC + A) compared to Corn Soy Blend Plus with fortified vegetable oil (CSB+ w/oil). We also estimated differences in costs and cost effectiveness of each supplement. METHODS: In Sierra Leone, we randomly assigned 29 health centers to provide a supplement containing 550 kcal/d for ∼12 wk to 2691 children with MAM aged 6-59 mo. We calculated cost per enrollee, cost per child who recovered, and cost per child who sustained recovery each from 2 perspectives: program perspective and caregiver perspective, combined. RESULTS: Of 2653 MAM children (98.6%) with complete data, 1676 children (63%) recovered. There were no significant differences in the odds of recovery compared to CSB+ w/oil [0.83 (95% CI: 0.64-1.08) for CSWB w/oil, 1.01 (95% CI: 0.78-1.3) for SC + A, 1.05 (95% CI: 0.82-1.34) for RUSF]. The odds of sustaining recovery were significantly lower for RUSF (0.7; 95% CI 0.49-0.99) but not CSWB w/oil or SC + A [1.08 (95% CI: 0.73-1.6) and 0.96 (95% CI: 0.67-1.4), respectively] when compared to CSB+ w/oil. Costs per enrollee [US dollars (USD)/child] ranged from $105/child in RUSF to $112/child in SC + A and costs per recovered child (USD/child) ranged from $163/child in RUSF to $179/child in CSWB w/oil, with overlapping uncertainty ranges. Costs were highest per sustained recovery (USD/child), ranging from $214/child with the CSB+ w/oil to $226/child with the SC + A, with overlapping uncertainty ranges. CONCLUSIONS: The 4 supplements performed similarly across recovery (but not sustained recovery) and costed measures. Analyses of posttreatment outcomes are necessary to estimate the full cost of MAM treatment. This trial was registered at clinicaltrials.gov as NCT03146897.

The use of oral nutritional supplements in the acute care setting.

Oral nutritional supplements offer support to patients in acute care who are undernourished or at risk of malnutrition. Yet doubts remain over cost and compliance. Omorogieva Ojo, Senior Lecturer in Primary Care at University of Greenwich weighs up the evidence.

Optimizing Ready-to-Use Therapeutic Foods for Protein Quality, Cost, and Acceptability.

This article describes current research on the development of alternative ready-to-use therapeutic foods (RUTFs) in the treatment of severe acute malnutrition. An innovative and versatile linear programming tool has been developed to facilitate the creation of therapeutic formulas that are determined acceptable on multiple levels: costs, ingredient acceptability, availability and stability, nutrient requirements, and personal preferences. The formulas are analyzed for ease of production by Washington University team members and for organoleptic properties acceptability to target populations. In the future, RUTF products that are cost-effective, acceptable, sustainable, and widely available will become a reality.

Ready-to-use foods for management of moderate acute malnutrition: considerations for scaling up production and use in programs.

Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are processed in a safe, reliable, and financially sustainable local production facility; and the effective use of these products in large-scale community-based programs. Linear programming tools can be used successfully to design local compositions that are in line with international guidelines, low in cost, and acceptable, and the efficacy of these local formulations in the treatment of MAM was recently demonstrated in Malawi. The production of local formulations for programs at scale relies on the existence of a reliable and efficient local production facility. Technical assistance may be required in the development of sustainable business models at an early stage in the process, taking into account the stringent product quality and safety criteria and the required investments. The use of ready-to-use products, as of any food supplement, in programs at scale will be affected by the practice of household sharing and diversion of these products for other uses. Additional measures can be considered to account for sharing. These products designed for the treatment and prevention of MAM are to be used in community-based programs and should therefore be used in conjunction with other interventions and designed so that they do not replace the intake of other foods and breastmilk. Remaining challenges and implications for the (operations) research agenda are discussed.

From diets to foods: using linear programming to formulate a nutritious, minimum-cost porridge mix for children aged 1 to 2 years.

BACKGROUND: Linear programming has been used extensively as a tool for nutritional recommendations. Extending the methodology to food formulation presents new challenges, since not all combinations of nutritious ingredients will produce an acceptable food. Furthermore, it would help in implementation and in ensuring the feasibility of the suggested recommendations. OBJECTIVE: To extend the previously used linear programming methodology from diet optimization to food formulation using consistency constraints. In addition, to exemplify usability using the case of a porridge mix formulation for emergency situations in rural Mozambique. METHODS: The linear programming method was extended with a consistency constraint based on previously published empirical studies on swelling of starch in soft porridges. The new method was exemplified using the formulation of a nutritious, minimum-cost porridge mix for children aged 1 to 2 years for use as a complete relief food, based primarily on local ingredients, in rural Mozambique. RESULTS: A nutritious porridge fulfilling the consistency constraints was found; however, the minimum cost was unfeasible with local ingredients only. This illustrates the challenges in formulating nutritious yet economically feasible foods from local ingredients. The high cost was caused by the high cost of mineral-rich foods. A nutritious, low-cost porridge that fulfills the consistency constraints was obtained by including supplements of zinc and calcium salts as ingredients. CONCLUSIONS: The optimizations were successful in fulfilling all constraints and provided a feasible porridge, showing that the extended constrained linear programming methodology provides a systematic tool for designing nutritious foods.

Scientific, economic, regulatory, and ethical challenges of bringing science-based pediatric nutrition products to the U.S. market and ensuring their availability for patients.

Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed.

Differences in resource utilization between patients with diabetes receiving glycemia-targeted specialized nutrition vs standard nutrition formulas in U.S. hospitals.

OBJECTIVES: The purpose of the study was to compare patient outcomes and costs for patients with diabetes mellitus (DM) receiving glycemia-targeted specialized nutrition (GTSN) with similar patients receiving standard nutrition (STDN) formulas during acute care hospitalizations. RESEARCH DESIGN AND METHODS: The study was designed as a retrospective analysis over a 10-year period (2000-2009) of clinical and cost data from 125,000 hospital inpatient episodes in the Premier Research Database. Patients received either GTSN or STDN, by tube or orally, as a component of comprehensive care for hyperglycemia in patients with DM. To adjust for potential cohort imbalances, GTSN patients were matched with STDN patients on the basis of propensity scores, adjusting for many characteristics, including age, sex, race, All Patient Refined Diagnosis-Related Group (APR-DRG) illness severity, APR-DRG mortality risk, and comorbidities. RESULTS: Tube-fed patients with DM who were provided GTSN had a 0.88-day (95% confidence interval [CI], 0.73-1.02) shorter length of hospital stay (LOS) on average compared with those patients provided STDN. Orally fed patients with DM who were provided GTSN had a 0.17-day (95% CI, 0.14-0.21) shorter LOS than did those patients provided STDN. The shorter LOS associated with GTSN contributed to a cost savings of $2586 for tube-fed patients and $1356 for orally fed patients. CONCLUSIONS: The use of GTSN feeding formulas for patients with DM in acute care hospital settings was associated with reduced LOS and inpatient hospital episode cost in comparison to STDN.

Cost-effectiveness analysis of immune-modulating nutritional support for gastrointestinal cancer patients.

BACKGROUND & AIM: Immune-modulating nutritional formula containing arginine, omega-3 fatty acids and nucleotides has been demonstrated to decrease complications and length of stay in surgical patients. This study aims at assessing the impact of immune-modulating formula on hospital costs in gastrointestinal cancer surgical patients in Switzerland. METHOD: Based on a previously published meta-analysis, the relative risks of overall and infectious complications with immune-modulating versus standard nutrition formula were computed. Swiss hospital costs of patients undergoing gastrointestinal cancer surgery were retrieved. A method was developed to compute the patients' severity level, not taking into account the complications from the surgery. Incremental costs of complications were computed for both treatment groups, and sensitivity analyses were carried out. RESULTS: Relative risk of complications with pre-, peri- and post-operative use of immune-modulating formula was 0.69 (95%CI 0.58-0.83), 0.62 (95%CI 0.53-0.73) and 0.73 (95%CI 0.35-0.96) respectively. The estimated average contribution of complications to the cost of stay was CHF 14,949 (€10,901) per patient (95%CI 10,712-19,186), independently of case's severity. Based on this cost, immune-modulating nutritional support decreased costs of hospital stay by CHF 1638 to CHF 2488 per patient (€1195-€1814). Net hospital savings were present for baseline complications rates as low as 5%. CONCLUSION: Immune-modulating nutritional solution is a cost-saving intervention in gastrointestinal cancer patients. The additional cost of immune-modulating formula are more than offset by savings associated with decreased treatment of complications.

Insurance coverage of medical foods for treatment of inherited metabolic disorders.

PURPOSE: Treatment of inherited metabolic disorders is accomplished by use of specialized diets employing medical foods and medically necessary supplements. Families seeking insurance coverage for these products express concern that coverage is often limited; the extent of this challenge is not well defined. METHODS: To learn about limitations in insurance coverage, parents of 305 children with inherited metabolic disorders completed a paper survey providing information about their use of medical foods, modified low-protein foods, prescribed dietary supplements, and medical feeding equipment and supplies for treatment of their child's disorder as well as details about payment sources for these products. RESULTS: Although nearly all children with inherited metabolic disorders had medical coverage of some type, families paid "out of pocket" for all types of products. Uncovered spending was reported for 11% of families purchasing medical foods, 26% purchasing supplements, 33% of those needing medical feeding supplies, and 59% of families requiring modified low-protein foods. Forty-two percent of families using modified low-protein foods and 21% of families using medical foods reported additional treatment-related expenses of $100 or more per month for these products. CONCLUSION: Costs of medical foods used to treat inherited metabolic disorders are not completely covered by insurance or other resources.

Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

Nutraceuticals and botanicals: overview and perspectives.

The discovery, development and marketing of food supplements, nutraceuticals and related products are currently the fastest growing segments of the food industry. Functional foods can be considered part or borderline to these products and may be defined as foods or food ingredients that have additional health or physiological benefits over and above the normal nutritional value they provide. This trend is driven by several factors, mainly due to the current consumer perceptions: the first and dominant being 'Natural is good', and other secondary, such as the increasing cost of many pharmaceuticals and their negative secondary effects, the insistent marketing campaign, the increasing perception of the need of a healthy diet and its importance in the health and homeostasis organism conditions. However, the central point is that nutraceuticals, botanicals and other herbal remedies, including the entry of new functional foods, are important because of their acceptance as the novel and modern forms to benefit of natural substances. Due to the rapid expansion in this area, the development of several aspects is considered as it could influence the future of the market of these products negatively: an imbalance existing between the increasing number of claims and products on the one hand, the development of policies to regulate their application and safety on the other, rapid and valuable controls to check the composition, including the plant extracts or adulteration to improve efficacy, like the presence of synthetic drugs. It is interesting to see that, from the negative factors reported by the market analysts, a change in consumers preferences is absent. The functional properties of many plant extracts, in particular, are being investigated for potential use as novel nutraceuticals and functional foods. Although the availability of scientific data is rapidly improving, the central aspect concerns the validation of these products. The first step of this crucial aspect is the security of the composition, obtained by the useful and adapted analytical approach. On the other hand, in the first instance, security is assured by the millenary use as food of the great majority of these plants. The importance and the novelty of functional food are inherent in the possibility to renew the secure use of plants to maintain healthiness of man in novel forms of use adapted to modern times. The market of 'other substances', after the emergence of the first period of enthusiastic explosion, is entering into the maturation period, with three important arguments to face: (a) security in composition, production and sale, avoiding easy conversions or convenient approaches and favouring competence and professionalism, (b) definition of influence of metabolic aspects, including scientific validation and (c) regulatory aspects, e.g. the claims definition and relative influences. The last aspect seams to be in primis the most crucial and fundamental to the future of all the sectors. The role of European Food and Safety Authority (EFSA) in the EU market must be considered and consequences if negative decisions on 'other substances' claim will be adopted in each country's legislation.

Analysis of the health economic impact of medical nutrition in the Netherlands.

OBJECTIVE: A health economic analysis was performed to assess the cost-effectiveness of oral nutritional supplements (ONS), being a medical nutrition product, in the Netherlands. METHODS: This analysis is based on a comparison of the use of ONS versus 'no use' of ONS in patients undergoing abdominal surgery. The costs and benefits of the two treatment strategies were assessed using a linear decision analytical model reflecting treatment patterns and outcomes in abdominal surgery. The incremental cost difference was based on costs associated with ONS and hospitalization. Clinical probabilities and resource utilization were based on clinical trials and published literature; cost data were derived from official price tariffs. RESULTS: The use of ONS reduces the costs with a \[euro] 252 (7.6%) cost saving per patient. The hospitalization costs reduce from \[euro] 3,318 to \[euro] 3,044 per patient, which is a 8.3% cost saving and corresponds with 0.72 days reduction in length of stay. The use of ONS would lead to an annual cost saving of a minimum of \[euro] 40.4 million per year. Sensitivity analyses showed that the use of ONS remains cost saving compared with 'no use' of ONS. A threshold analysis on the length of stay shows that at 0.64 days, the use of ONS is still cost-effective, which is an unrealistic value. CONCLUSIONS: This analysis shows that the use of medical nutrition, ONS in this case, is a cost-effective treatment in the Netherlands and is dominant over standard care without medical nutrition: it leads to cost savings and a higher effectiveness.

Cost-effectiveness of nutrition interventions in nursing home residents: a pilot intervention.

OBJECTIVES: Unintentional weight loss is a prevalent and costly clinical problem among nursing home (NH) residents. One of the most common nutrition interventions for residents at risk for weight loss is oral liquid nutrition supplementation. The purpose of this study was to determine the cost effectiveness of supplements relative to offering residents' snack foods and fluids between meals to increase caloric intake. DESIGN: Randomized, controlled trial. SETTING: Three long-term care facilities. PARTICIPANTS: Sixty-three long-stay residents who had an order for nutrition supplementation. INTERVENTION: Participants were randomized into one of three groups: (1) usual NH care control; (2) supplement, or (3) between-meal snacks. For groups two and three, trained research staff provided supplements or snacks twice daily between meals, five days per week, for six weeks with assistance and encouragement to promote consumption. MEASUREMENTS: Research staff observed residents during and between meals for two days at baseline, weekly, and post six weeks to estimate total daily caloric intake. For both intervention groups, research staff documented residents' caloric intake between meals from supplements or snack items, refusal rates and the amount of staff time required to provide each intervention. RESULTS: Both interventions increased between meal caloric intake significantly relative to the control group and required more staff time than usual NH care. The snack intervention was slightly less expensive and more effective than the supplement intervention. CONCLUSIONS: Offering residents a choice among a variety of foods and fluids twice per day may be a more effective nutrition intervention than oral liquid nutrition supplementation.

Sensory properties of ginseng solutions modified by masking agents.

Ginseng is one of the most popular functional ingredients found in energy drink formulations. Although ginseng is known for its health benefits, ginseng is also notorious for imparting a bitter taste. Incorporating ginseng into beverages without the bitterness, while still maintaining its health benefits, is necessary for developing an acceptable product. Thus, the objectives of this study were to (1) identify effective treatments for minimizing the bitterness of ginseng in water base and model energy drink base solutions and (2) determine the sensory effects of incorporating different treatment levels to minimize the bitterness of ginseng. A series of pilot studies investigating bitterness reducing treatments were conducted, which included: congruent flavor addition, bitterness blocking agent incorporation, enzymatic modification, ingredient interaction, and complexation. Based on the results of a series of pilot studies, γ-cyclodextrin (γ-CD) and ß-cyclodextrin (ß-CD) complexation agents were identified as having the most potential. Effectiveness of the γ-CDs, ß-CDs, and combinations of γ- and ß-CDs were tested in 100 mL water and in 100 mL model energy drink base solutions containing 0.052 g 80% ginsenosides panax ginseng, using descriptive sensory analysis. Twelve trained panelists evaluated 42 solution treatments (3 treatments × 7 levels × 2 bases) for bitter attributes with and without nose clips. Overall, the most effective treatments were 0.09 g γ-CDs in 100 mL of solution and 1 g ß-CDs in 100 mL solution, which both reduced the bitterness intensity of the solutions by half. Incorporation of these levels of CDs in water and model energy drink base solutions containing ginseng will aid in the development of functional beverages that are more acceptable to a wider range of consumers.

Effect of flaxseed gum on reduction of blood glucose and cholesterol in type 2 diabetic patients.

The effects of ingestion of flaxseed gum on blood glucose and cholesterol, particularly low-density lipoprotein cholesterol, in type 2 diabetes were evaluated. Flaxseed gum was incorporated in wheat flour chapattis. Sixty patients of type 2 diabetes were fed a daily diet for 3 months, along with six wheat flour chapattis containing flaxseed gum (5 g), as per the recommendations of the American Diabetic Association. The control group (60 individuals) consumed an identical diet but the chapattis were without gum. The blood biochemistry profiles monitored before starting the study and at monthly intervals showed fasting blood sugar in the experimental group decreased from 154 ± 8 mg/dl to 136 ± 7 mg/dl (P=0.03) while the total cholesterol reduced from 182 ± 11 mg/dl to 163 ± 9 mg/dl (P=0.03). Results showed a decrease in low-density lipoprotein cholesterol from 110 ± 8 mg/dl to 92 ± 9 mg/dl (P=0.02). The study demonstrated the efficacy of flax gum in the blood biochemistry profiles of type 2 diabetes.

Usefulness of the daily defined dose method to estimate trends in the consumption, costs and prevalence of the use of home enteral nutrition.

BACKGROUND & AIMS: To analyse the trends in consumption and costs of home enteral nutrition (HEN) products in Andalusia (Spain) and estimate the prevalence of HEN from 2000 to 2007. METHODS: Using the defined daily dose (DDD) method, we assigned a DDD to each type of diet, grouped as whole diets, supplements, modules and thickeners. The number of cases/10(6) inhabitants/day (CID) was calculated. RESULTS: The number of persons receiving HEN rose notably, from 66.4 CID in 2000 to 1315.4 in 2007. The number of persons with home enteral tube feeding has remained stable since 2003, at around 220 CID. HEN with oral nutritional supplements (ONS) increased exponentially, with a prevalence of 910 CID in 2007. The prevalence of HEN in 2007 was similar to that of other European countries. The costs associated with HEN rose from 1.3 million euros in 2000 to over 37 million euros in 2007, due to the progressive increase in the number of persons being prescribed HEN, especially ONS, and the incorporation of more expensive organ-specific formulas. CONCLUSIONS: DDD is useful to indirectly estimate the prevalence of HEN and evaluate long-term trends in the prescription and costs of various HEN products.