Special Low Protein Foods Prescribed in England for PKU Patients: An Analysis of Prescribing Patterns and Cost.

Patients with phenylketonuria (PKU) are reliant on special low protein foods (SLPFs) as part of their dietary treatment. In England, several issues regarding the accessibility of SLPFs through the national prescribing system have been highlighted. Therefore, prescribing patterns and expenditure on all SLPFs available on prescription in England (n = 142) were examined. Their costs in comparison to regular protein-containing (n = 182) and 'free-from' products (n = 135) were also analysed. Similar foods were grouped into subgroups (n = 40). The number of units and costs of SLPFs prescribed in total and per subgroup from January to December 2020 were calculated using National Health Service (NHS) Business Service Authority (NHSBSA) ePACT2 (electronic Prescribing Analysis and Cost Tool) for England. Monthly patient SLPF units prescribed were calculated using patient numbers with PKU and non-PKU inherited metabolic disorders (IMD) consuming SLPFs. This was compared to the National Society for PKU (NSPKU) prescribing guidance. Ninety-eight percent of SLPF subgroups (n = 39/40) were more expensive than regular and 'free-from' food subgroups. However, costs to prescribe SLPFs are significantly less than theoretical calculations. From January to December 2020, 208,932 units of SLPFs were prescribed (excluding milk replacers), costing the NHS £2,151,973 (including milk replacers). This equates to £962 per patient annually, and prescribed amounts are well below the upper limits suggested by the NSPKU, indicating under prescribing of SLPFs. It is recommended that a simpler and improved system should be implemented. Ideally, specialist metabolic dietitians should have responsibility for prescribing SLPFs. This would ensure that patients with PKU have the necessary access to their essential dietary treatment, which, in turn, should help promote dietary adherence and improve metabolic control.

Impact of stakeholder perspectives on cost-effectiveness estimates of four specialized nutritious foods for preventing stunting and wasting in children 6-23 months in Burkina Faso.

BACKGROUND: Multiple specialized nutritious food options are programmed for supplementation in humanitarian and development settings. However, comparative cost-effectiveness evidence is lacking, let alone incorporation of perspectives from uncompensated stakeholders. A Burkina Faso trial evaluated the cost-effectiveness of Corn Soy Blend Plus w/ oil (CSB+ w/oil, reference arm), Corn Soy Whey Blend w/oil (CSWB w/oil), Super Cereal Plus (SC+), and Ready-to-Use Supplementary Food (RUSF) in reducing stunting and wasting among children 6-23 months old. This paper presents cost-effectiveness findings from multiple stakeholders' perspectives, including caregivers and program volunteers. METHODS: An activity-based costing with ingredients approach was used to summarize cost of the 18-month-long blanket supplementary feeding for each enrolled child (in 2018 USD). Time data were collected using self-reported and observational instruments. Cost-effectiveness relative to CSB+ w/oil assessed incremental cost per enrolled child against incremental outcomes: prevalence of stunting at 23 months of age and number of months of wasting. Two combined perspectives were compared: program (donor, implementer, and volunteer) versus program and caregiver (adding caregiver). RESULTS: A total of 6112 children were enrolled. While similar effectiveness was found in three arms (CSWB w/oil was less effective), costs differed. Product cost and caregiver time to prepare study foods were major drivers of cross-arm cost differences from the respective combined perspective. The two major drivers were used to construct uncertainty ranges of cost per enrolled child from program and caregiver perspective: $317 ($279- $355) in CSB+ w/oil, $350 ($327- $373) in CSWB w/oil, $387 ($371- $403) in RUSF, and $434 ($365- $503) in SC+. Cost from program and caregiver perspective was a substantial increase from program perspective. CSB+ w/oil was most cost-effective in reducing stunting and wasting, and this main finding was robust to changing perspectives and all corresponding sensitivity analyses when uncompensated time was valued at minimum wage ($0.36/h). The break-even point for uncompensated time valuation is >$0.84/h, where RUSF became the most cost-effective from the program and caregiver perspective. Relative cost-effectiveness rankings among the other three arms depended on choice of perspectives, and were sensitive to values assigned to product cost, international freight cost, opportunity cost of time, and outcomes of a hypothetical control. Volunteer opportunity cost did not affect arm comparisons, but lack of compensation resulted in negative financial consequences for caregivers. CONCLUSIONS: Evaluating cost-effectiveness by incorporating uncompensated stakeholders provided crucial implementation insights around nutrition products and programming. TRIAL REGISTRATION: Trial registration number: NCT02071563. Name of registry: ClinicalTrials.gov URL of registry: https://clinicaltrials.gov/ct2/show/NCT02071563?type=Intr&cond=Malnutrition&cntry=BF&draw=2&rank=9 Date of registration: February 26, 2014. Date of enrollment of first participant: July 2014.

Persistent Economic Burden of the Gluten Free Diet.

Gluten free (GF) products have been reported to be more expensive and less available than their gluten containing counterparts. We examined the current U.S. cost and availability of GF products and made comparisons to the marketplace over a decade ago. Cost, determined by price per ounce and availability of a "market basket" of regular and GF products across four venues and five geographic regions was compared using a student's t test. GF products were more expensive (overall 183%), and in all regions and venues (p < 0.001). GF products from mass-market producers were 139% more expensive than the wheat-based version of the same product. Availability of GF products was greatest (66%) in the health food and upscale venues. In contrast to the results of the 2006 study, the cost of GF products has declined from 240% to 183% (adjusted for inflation). The introduction of mass-market production of GF products may have influenced the increase in availability and overall reduction of cost since 2006. The extent to which the cost of GF products impacts dietary adherence and quality of life for those on a GFD warrants exploration.

The Availability and Nutritional Adequacy of Gluten-Free Bread and Pasta.

Management of coeliac disease (CD) requires the removal of gluten from the diet. Evidence of the availability, cost, and nutritional adequacy of gluten-free (GF) bread and pasta products is limited. GF flours are exempt from UK legislation that requires micronutrient fortification of white wheat flour. This study surveyed the number and cost of bread and pasta products available and evaluated the back-of-pack nutritional information, the ingredient content, and the presence of fortification nutrients of GF bread and pasta, compared to standard gluten-containing equivalent products. Product information was collected from four supermarket websites. Standard products were significantly cheaper, with more products available than GF (p < 0.05). GF bread products were significantly higher in fat and fiber (p < 0.05). All GF products were lower in protein than standard products (p < 0.01). Only 5% of GF breads were fortified with all four mandatory fortification nutrients (calcium, iron, niacin, and thiamin), 28% of GF breads were fortified with calcium and iron only. This lack of fortification may increase the risk of micronutrient deficiency in coeliac sufferers. It is recommended that fortification legislation is extended to include all GF products, in addition to increased regulation of the nutritional content of GF foods.

Antinutritional factors and hypocholesterolemic effect of wild apricot kernel (Prunus armeniaca L.) as affected by detoxification.

The present investigation was aimed to study the effect of detoxification on the nutrients and antinutrients of wild apricot kernel followed by its hypocholesterolemic effect in male Wistar albino rats. The results revealed a non-significant (p > 0.05) effect of detoxification on the proximate composition except total carbohydrates and protein content. However, detoxification led to a significant (p < 0.05) decrease in l-ascorbic acid (76.82%), ß-carotene (25.90%), dietary fiber constituents (10.51-28.92%), minerals (4.76-31.08%) and antinutritional factors (23.92-77.05%) (phenolics, tannins, trypsin inhibitor activity, saponins, phytic acid, alkaloids, flavonoids, oxalates) along with the complete removal (100%) of bitter and potentially toxic hydrocyanic acid (HCN). The quality parameters of kernel oil indicated no adverse effects of detoxification on free fatty acids, lipase activity, acid value and peroxide value, which remained well below the maximum permissible limit. Blood lipid profile demonstrated that the detoxified apricot kernel group exhibited significantly (p < 0.05) increased levels of HDL-cholesterol (48.79%) and triglycerides (15.09%), and decreased levels of total blood cholesterol (6.99%), LDL-C (22.95%) and VLDL-C (7.90%) compared to that of the raw (untreated) kernel group. Overall, it can be concluded that wild apricot kernel flour could be detoxified efficiently by employing a simple, safe, domestic and cost-effective method, which further has the potential for formulating protein supplements and value-added food products.

An investigation into the nutritional composition and cost of gluten-free versus regular food products in the UK.

BACKGROUND: The gluten-free (GF) food market has expanded considerably, although there is limited comparative evidence for the nutritional quality and cost of GF food products. The present study aims to compare the nutrient composition and cost of GF and gluten-containing (regular) foods across 10 food categories in the UK. METHODS: Nutritional information and the cost of GF foods available in the UK (n = 679) and comparable regular foods (n = 1045) were systematically collected from manufacturer and supermarket websites. Foods were classified using UK front-of-pack labelling for content of fat, saturated fat, sugar and salt and nutrient content, and cost per 100 g were identified and compared between GF and regular foods. RESULTS: Overall, more GF foods were classified as containing high and medium fat, saturated fat, sugar and salt than regular foods, although this was not universally consistent. More GF bread and flour products contained high fat and sugar, whereas fewer GF crackers contained high fat and sugar compared to regular foods. High salt content was found more frequently in GF than regular products. On average, GF products were 159% more expensive than regular (£0.44/100 g versus £1.14/100 g). GF items were also more likely to be lower in fibre and protein content than regular foods. CONCLUSIONS: Differences exist in the nutritional composition of GF and regular food. GF food is unlikely to offer healthier alternatives to regular foods, except for those who require a GF diet for medically diagnosed conditions, and it is associated with higher costs.

Gluten-Free Diet Indications, Safety, Quality, Labels, and Challenges.

A gluten-free diet (GFD) is the safest treatment modality in patient with coeliac disease (CD) and other gluten-related disorders. Contamination and diet compliance are important factors behind persistent symptoms in patients with gluten related-disorders, in particular CD. How much gluten can be tolerated, how safe are the current gluten-free (GF) products, what are the benefits and side effects of GFD? Recent studies published in Nutrients on gluten-free products' quality, availability, safety, as well as challenges related to a GFD are discussed.

Exchanging a few commercial, regularly consumed food items with improved fat quality reduces total cholesterol and LDL-cholesterol: a double-blind, randomised controlled trial.

The healthy Nordic diet has been previously shown to have health beneficial effects among subjects at risk of CVD. However, the extent of food changes needed to achieve these effects is less explored. The aim of the present study was to investigate the effects of exchanging a few commercially available, regularly consumed key food items (e.g. spread on bread, fat for cooking, cheese, bread and cereals) with improved fat quality on total cholesterol, LDL-cholesterol and inflammatory markers in a double-blind randomised, controlled trial. In total, 115 moderately hypercholesterolaemic, non-statin-treated adults (25-70 years) were randomly assigned to an experimental diet group (Ex-diet group) or control diet group (C-diet group) for 8 weeks with commercially available food items with different fatty acid composition (replacing SFA with mostly n-6 PUFA). In the Ex-diet group, serum total cholesterol (P<0·001) and LDL-cholesterol (P<0·001) were reduced after 8 weeks, compared with the C-diet group. The difference in change between the two groups at the end of the study was -9 and -11 % in total cholesterol and LDL-cholesterol, respectively. No difference in change in plasma levels of inflammatory markers (high-sensitive C-reactive protein, IL-6, soluble TNF receptor 1 and interferon-γ) was observed between the groups. In conclusion, exchanging a few regularly consumed food items with improved fat quality reduces total cholesterol, with no negative effect on levels of inflammatory markers. This shows that an exchange of a few commercially available food items was easy and manageable and led to clinically relevant cholesterol reduction, potentially affecting future CVD risk.

The Future of Infant and Young Children's Food: Food Supply/Manufacturing and Human Health Challenges in the 21st Century.

Infant food and weaning practices are highly debated with lots of unanswered questions. It is becoming more apparent that early-life feeding may have an effect on the long-term health of humans, particularly for noncommunicable diseases such as obesity and allergic diseases. It is important to understand how environmental influences in early life can affect the development of the immune system and metabolic profiling. In terms of nutrition and diet, one should consider the role of the total/whole diet, as well as particular nutrients in the development of noncommunicable diseases. Providing the appropriate nutrition for infants during the weaning age needs to address factors such as the microbial load of the food, nutrient composition, presence/absence of allergens and appropriate textures. These factors are of importance irrespective of whether the food is homemade or produced commercially, and need to take environmental factors and food resources into account.

Rheology and microstructure of binary mixed gel of rice bran protein-whey: effect of heating rate and whey addition.

BACKGROUND: Rice bran protein (RBP) is a valuable plant protein which has unique nutritional and hypoallergenic properties. Whey proteins have wide applications in the food industry, such as in dairy, meat and bakery products. RESULTS: Whey protein concentrate (WPC), RBP and their mixtures at different ratios (1:1, 1:2, 1:5 and 1:10 w/w) were heated from 20 to 90 °C at different heating rates (0.5, 1, 5 and 10 °C min(-1) ). The storage modulus (G') and gelling point (Tgel ) of WPC were higher than those of RBP, indicating the good ability of WPC to develop stiffer networks. By increasing the proportion of WPC in mixed systems, G' was increased and Tgel was reduced. Nevertheless, the elasticity of all binary mixtures was lower than that of WPC alone. Tgel and the final G' of RBP-WPC blends were increased by raising the heating rate. The RBP-WPC mixtures developed more elastic gels than RBP alone at different heating rates. RBP had a fibrillar and lentil-like structure whose fibril assembly had smaller structures than those of WPC. CONCLUSION: The gelling structure of the mixed gel of WPC-RBP was improved by adding WPC. Indeed, by adding WPC, gels tended to show syneresis and had lower water-holding capacity. Furthermore, the gel structure was produced by adding WPC to the non-gelling RBP, which is compatible with whey and can be applied as a functional food for infants and/or adults. © 2015 Society of Chemical Industry.

Differences in the nutritional content of baby and toddler foods with front-of-package nutrition claims issued by manufacturers v. governments/health organizations.

OBJECTIVE: Nutritional information panels are required on all packaged food products in the USA, yet are perceived as difficult to use by consumers. Nutritional symbols have been developed by various groups to assist consumers in making healthier food purchases. Different nutritional criteria are used depending on the authorizing body of these symbols. The present study assesses the nutrient profile of baby and toddler foods in light of their accompanying nutritional symbols. DESIGN: Kruskal-Wallis and χ 2 tests were used to assess differences in the nutritional content of products based on the presence and issuing body of nutritional symbols. SETTING: Nine grocery, drug and department stores in Philadelphia, PA, USA. SUBJECTS: Two hundred and forty packaged baby and toddler foods. RESULTS: Products whose nutritional symbol was issued by government/health professionals contained significantly more Ca (P = 0·002), fibre (P = 0·001), protein (P = 0·005), vitamin A (P = 0·011), vitamin C (P < 0·001) and Zn (P < 0·001) and less sugar (P = 0·004) per serving than products without a nutritional symbol and products whose nutritional symbol was issued by the manufacturer. CONCLUSIONS: Products with a nutritional symbol issued by government/health professionals were healthier than foods with nutritional symbols issued by the manufacturer directly and foods with no nutritional symbols.

Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.

Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

Gluten-free is not enough--perception and suggestions of celiac consumers.

The present study investigated the perceptions of individuals with celiac disease about gluten-free (GF) products, their consumer behavior and which product is the most desired. A survey was used to collect information. Descriptive analysis, χ² tests and Multiple Logistic Regressions were conducted. Ninety-one questionnaires were analyzed. Limited variety and availability, the high price of products and the social restrictions imposed by the diet were the factors that caused the most dissatisfaction and difficulty. A total of 71% of the participants confirmed having moderate to high difficulty finding GF products. The logistic regression identified a significant relationship between dissatisfaction, texture and variety (p < 0.05) and between variety and difficulty of finding GF products (p < 0.05). The sensory characteristics were the most important variables considered for actual purchases. Bread was the most desired product. The participants were dissatisfaction with GF products. The desire for bread with better sensory characteristics reinforces the challenge to develop higher quality baking products.

Evaluation of visual and taste preferences of some gluten-free commercial products in a group of celiac children.

The purpose of this study was to investigate the visual and taste liking of three commercial gluten-free (GF) foods in a group of celiac children. Thirty celiac children, with diagnosis of celiac disease from more than 2 years, were recruited and 28 (21 females and 7 males, mean age 8.7 years) completed the study. Subjects performed individually six sensory tests, two for each product in different days separated by a week. In the test day, children had to evaluate the liking of the same type of product but of different four brands, before and after tasting them with a 5-point facial rating scale. Overall, the results showed that the majority of children appreciated more the appearance than the taste of all the GF products analysed. The present study provides the first and useful indications on the hedonic perceptions of celiac children about some commercial GF products.

The role of the concept of "history of safe use" in the safety assessment of novel foods and novel food ingredients. Opinion of the Senate Commission on Food Safety (SKLM) of the German Research Foundation (DFG).

The Council of the European Union has proposed a revision on the EU regulation on novel foods and novel food ingredients concerning safety assessment of traditional foods from non-EU countries and their introduction onto the EU market. The proposal stipulates that such foods may be placed on the EU market if their history of safe use in the country of origin is appropriately documented. The present statement of the SKLM gives an overview on current discussions on practical implementation of the "history of safe use" concept as well as examples of its application. The SKLM, in principle, agrees with these concepts, underscores, however, in connection with convincing evidence for a "history of safe use" the need for a range of additional information to achieve a comprehensive risk assessment. In the opinion of the SKLM such information must comprise compositional data as well as experience on adverse effects. A list of questions considered essential is presented. The following opinion was adopted on December 23rd 2010.

Ready-to-use therapeutic food for prevention of childhood undernutrition.

Undernutrition is a major contributor to child mortality and total global disease burden. Ready-to-use therapeutic food (RUTF) is recommended by the World Health Organization for community-based management of uncomplicated forms of severe acute malnutrition. New research has evaluated the role of RUTF for the prevention of childhood undernutrition. While studies have found some benefit, similar results have been seen with supplemental food aid and controversy over the role for RUTF in prevention efforts continues. For the prevention of childhood malnutrition, the following questions remain critical: Who should receive a specific nutrition intervention? What composition and form should the intervention take? And, when should the intervention be delivered?

Economic analysis of a diabetes-specific nutritional meal replacement for patients with type 2 diabetes.

This study extends nutritional intervention results reported by short-term clinical trials of a diabetes-specific nutritional meal replacement by assessing the ten-year impact of the interventions on patient outcomes and costs compared to usual care. We developed and validated a computer simulation of type 2 diabetes based on published data from major clinical trials. The model tracks patients through microvascular and macrovascular health states and reports cumulative costs and quality adjusted life years. We modeled different scenarios that include a diabetes-specific nutritional meal replacement as part of a structured lifestyle intervention, and also as the only difference between the intervention and usual care treatment groups, and compared them to usual care with diet and physical activity recommendations. We used sensitivity analysis to explore the robustness of results. When a diabetes-specific nutritional meal replacement is the only treatment difference and is considered an equal cost meal replacement, the diabetes-specific nutritional meal replacement interventions are less costly and more effective than usual care. As an added cost meal replacement, the diabetes-specific nutritional meal replacement has an incremental cost-effectiveness ratio between $50,414 and $55,036 depending on improvement in percent glycated hemoglobin. A hypothetical lifestyle intervention using a diabetes-specific nutritional meal replacement has an incremental cost-effectiveness ratio of $47,917. The diabetes-specific nutritional meal replacement was found to be cost-effective under the various conditions simulated.