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Background A scientific framework on exposure science will boost the multiuse of exposure knowledge across EU chemicals-related policies and improve risk assessment, risk management and communication across EU safety, security and sustainability domains. Objective To stimulate public and private actors to align and strengthen the cross-policy adoption of exposure assessment data, methods and tools across EU legislation. Methods By mapping and analysing the EU regulatory landscape making use of exposure information, policy and research challenges and key areas of action are identified and translated into opportunities enhancing policy and scientific efficiency. Results Identified key areas of actions are to develop a common scientific exposure assessment framework, supported by baseline acceptance criteria and a shared knowledge base enhancing exchangeability and acceptability of exposure knowledge within and across EU chemicals-related policies. Furthermore, such framework will improve communication and management across EU chemical safety, security and sustainability policies comprising sourcing, manufacturing and global trade of goods and waste management. In support of building such a common framework and its effective use in policy and industry, exposure science innovation needs to be better embedded along the whole policymaking cycle, and be integrated into companies’ safety and sustainability management systems. This will help to systemically improve regulatory risk management practices. Significance This paper constitutes an important step towards the implementation of the EU Green Deal and its underlying policy strategies, such as the Chemicals Strategy for Sustainability.

In the transition to a sustainable society, many new technologies and materials are developed. These often have disadvantages, examples thereof with a sustainability claim that entailed risks to public health are identified. Risk Governance should ideally address and deal with those potential risks. However, governance mechanisms to efficiently deal with these risks seem to be lacking. In this study, the Risk Governance in the lifecycle of three innovative bio-based plastic food contact materials (FCMs) were evaluated. Interviews were conducted with representatives of all stages in the lifecycle to identify risk management strategies to prevent or control public health risk. Experts were asked to share their views on the identified strategies. Nineteen different risk management strategies have been identified from the three case studies and compared with the principles of the International Risk Governance Council (IRGC) framework and showed that less than 50% corresponded to those of the IRGC framework. In addition, eighteen randomly sampled bio-based FCMs were chemically analysed to get insight in the presence of potentially hazardous substances. The presence of hazardous chemicals in the bio-based FCMs provide indications of potential chemical health risks. Apparently, there is no structural application of risk governance in the three bio-based FCM studied. Strategies are applied to manage public health risks, but these are usually implemented too limited to effectively manage the identified risks.

Stimulation of gastrointestinal taste receptors affects eating behaviour. Intraduodenal infusion of tastants leads to increased satiation and reduced food intake, whereas intraileal infusion of tastants does not affect eating behaviour. Currently, it is unknown whether oral- or intragastric administration of tastants induces a larger effect on eating behaviour. This study investigated the effects of oral- and/or intragastric administration of quinine on food intake, appetite sensations and heart rate variability (HRV). In a blinded randomised crossover trial, thirty-two healthy volunteers participated in four interventions with a 1-week washout: oral placebo and intragastric placebo (OPGP), oral quinine and intragastric placebo (OQGP), oral placebo and intragastric quinine (OPGQ) and oral quinine and intragastric quinine (OQGQ). On test days, 150 min after a standardised breakfast, subjects ingested a capsule containing quinine or placebo and were sham-fed a mixture of quinine or placebo orally. At 50 min after intervention, subjects received an ad libitum meal to measure food intake. Visual analogue scales for appetite sensations were collected, and HRV measurements were performed at regular intervals. Oral and/or intragastric delivery of the bitter tastant quinine did not affect food intake (OPGP: 3273·6 (sem 131·8) kJ, OQGP: 3072·7 (sem 132·2) kJ, OPGQ: 3289·0 (sem 132·6) kJ and OQGQ: 3204·1 (sem 133·1) kJ, P = 0·069). Desire to eat and hunger decreased after OQGP and OPGQ compared with OPGP (P < 0·001 and P < 0·05, respectively), whereas satiation, fullness and HRV did not differ between interventions. In conclusion, sole oral sham feeding with and sole intragastric delivery of quinine decreased desire to eat and hunger, without affecting food intake, satiation, fullness or HRV.

Serious concerns are expressed on the safe use of red yeast rice (RYR) supplements. The aim of the present study was to analyse cases received by Lareb on RYR-related adverse health events. These cases were analysed for the number of reports, number of adverse drug reactions (ADRs), causality, seriousness of the reaction, latency-period, age and sex of the patients, concomitant medication and type of reporter. A total of 94 individual reports were collected by Lareb, corresponding with 187 ADRs. The analysis showed most reported ADRs were labelled musculoskeletal and connective tissue disorders (n = 64), gastrointestinal disorders (n = 33) and general disorders and administration site conditions (n = 23). The use of RYR supplements should be considered as a significant safety concern. Exposure to monacolin K could lead to serious adverse effects. To fully assess the safety profile of RYR supplements, more research is necessary to compose a complete ADR profile of RYR supplements.

Commercial food packages may contain multiple messages. Packaging designers try to integrate all messages into a coherent design. Designers may use text, images or stylistic features, but these mediums may differ in their suitability to communicate specific product benefits. To evaluate the usefulness and effectiveness of these three mediums, we not only obtained consumer evaluations of packaging designs, but we also monitored the designer’s experience during the design process. For three products (orange juice, muesli bar, plain yogurt) we created three consistent packaging designs communicating a single benefit through all three mediums, which was either a [1] health, [2] environmental, or [3] production, sensory or social claim. Subsequently, we developed inconsistent packages communicating three different messages through the three mediums. In an online survey, each of the 18 package variants was evaluated by 59–92 participants. Dummy regression analysis suggested that verbal claims had positive effects in communicating healthiness and environmental friendliness but elicited a negative tendency for sensory properties. The images we used indicated a positive effect for communicating worker conditions, but a negative effect for healthiness. Our stylistic elements suggested a positive effect for sensory appeal, but tended to have negative effects for environmental aspects. As regards designer dilemmas, we noticed that some images (e.g., in the medical domain) required specific graphic styles to make them acceptable for commercial use. Our findings suggest that consumers can handle multiple packaging messages, but finding an optimal configuration remains a design challenge.

BackgroundDairy alternatives are foods that are made from plant-based milk instead of their usual animal products, such as cheese and yoghurt. Over the past few years, consumers increasingly choose to go dairy-free, which leads to a growth in available dairy alternatives product on the market. Although it is easiest for consumers to identify these products by the use of protected dairy terms (‘yoghurt’ or ‘milk’), these protected terms may not be used by food business operators to designate their plant-based products.Scope and approachThis article will examine the positive and negative impact of the EU regulatory framework on innovation in the dairy alternative industry and its consumers. Furthermore, potential solutions to overcome the identified barriers are explored.Key findings and conclusionsThe EU regulatory framework has positively affected innovation in the dairy alternatives industry by establishing legal clarity, and ensuring a high level of food safety and consumer protection. However, the same legislation negatively impacts innovation in the industry, namely due to: (i) the varying interpretation of the Regulation (EU) 1308/2013 (CMO); (ii) the different level of consumer protection between sectors; (iii) the absence of a legal definition of vegan food; and (iv) the narrow definition of ‘milk’ and ‘milk products’ as defined in the CMO. Either amending the definition of milk and milk products in the CMO, or expanding the list of exceptions to the definitions are identified as possible solutions to deal with the identified barriers.

Objectives To study the effects of running with/without the use of pain killers on urinary neutrophil gelatinase-associated lipocalin (uNGAL) and other parameters of kidney function in recreational runners. Methods Participants of the 10- and 21.1-km Weir Venloop race were enrolled and their urine samples collected before and after the run. Urine dipstick and other conventional tests used to assess kidney function were performed. The presence of ibuprofen, diclofenac, naproxen, and/or paracetamol was assessed by LC-MS/MS. uNGAL was measured with a two-step chemiluminescent immunoassay. Results NSAIDs/analgesics were detected in urine of 5 (14.4%) 10-km runners and 13 (28.9%) 21.1-km runners. Only half-marathon participants showed significant increases in uNGAL (pre: 11.7 [7.1-34.3] ng/mL; post: 33.4 [17.4-50.4] ng/mL;P = .0038). There was a significant effect of NSAID/analgesic use on uNGAL increase (F-2,F- 76 = 4.210,P = .004). Post hoc tests revealed that uNGAL increased significantly in runners who tested positive for ibuprofen/naproxen compared to runners who did not use any medications (P = .045) or those who tested positive for paracetamol (P = .033). Running distance had a significant influence on the increase in uNGAL (F-1,F- 53 = 4.741,P

Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws attention to the important role of EU food law in the regulation of this innovative approach to nutrition. It is argued that personalised nutrition challenges the regulatory borderline between health and lifestyle products or services and, furthermore, also pushes the boundaries of current food safety and health claims legislation.

Correction: Chemical Senses, Volume 46, 2021, bjab050, https://doi.org/10.1093/chemse/bjab050 Published: 08 December 2021 Recent anecdotal and scientific reports have provided evidence of a link between COVID-19 and chemosensory impairments, such as anosmia. However, these reports have downplayed or failed to distinguish potential effects on taste, ignored chemesthesis, and generally lacked quantitative measurements. Here, we report the development, implementation, and initial results of a multilingual, international questionnaire to assess self-reported quantity and quality of perception in 3 distinct chemosensory modalities (smell, taste, and chemesthesis) before and during COVID-19. In the first 11 days after questionnaire launch, 4039 participants (2913 women, 1118 men, and 8 others, aged 19-79) reported a COVID-19 diagnosis either via laboratory tests or clinical assessment. Importantly, smell, taste, and chemesthetic function were each significantly reduced compared to their status before the disease. Difference scores (maximum possible change +/- 100) revealed a mean reduction of smell (-79.7 +/- 28.7, mean +/- standard deviation), taste (-69.0 +/- 32.6), and chemesthetic (-37.3 +/- 36.2) function during COVID-19. Qualitative changes in olfactory ability (parosmia and phantosmia) were relatively rare and correlated with smell loss. Importantly, perceived nasal obstruction did not account for smell loss. Furthermore, chemosensory impairments were similar between participants in the laboratory test and clinical assessment groups. These results show that COVID-19-associated chemosensory impairment is not limited to smell but also affects taste and chemesthesis.The multimodal impact of COVID-19 and the lack of perceived nasal obstruction suggest that severe acute respiratory syndrome coronavirus strain 2 (SARS-CoV-2) infection may disrupt sensory-neural mechanisms.

Purpose Chemotherapy can affect smell and taste function. This has never been investigated in childhood cancer patients during chemotherapy. The objective of this study was to determine whether psychophysical smell and taste tests are suitable for children with cancer. Taste and smell function, fungiform papillae density, and eating behavior were measured before (T1) and after (T2) a cycle of chemotherapy and compared with healthy controls. Methods Thirty-one childhood cancer patients treated for a hematological, solid, or brain malignancy (median age 12 years, 16 girls), and 24 healthy controls (median age: 11 years, 10 girls) participated. Smell function was measured using Sniffin’ Sticks, including a threshold, discrimination, and identification test. Taste Strips were used to determine recognition thresholds for sweet, sour, salty, and bitter taste. Papillae density was investigated by counting the fungiform papillae of the anterior tongue. Eating behavior was assessed using the Behavioral Pediatrics Feeding Assessment Scale (BPFAS). Results Smell and taste function could be investigated in more than 90% of the patients, while fungiform papillae density could be determined in 61% of the patients. A significant difference in smell threshold was found between patients and controls (p = 0.001), showing lower thresholds in patients. In patients, sweet taste (p p = 0.028), and total taste function (p = 0.004) were significantly different after a cycle of chemotherapy, with higher scores at T2. Conclusion The assessment of smell, taste, and fungiform papillae density is feasible in children with cancer. Results of the current study suggest that smell and taste sensitivity increased in children with cancer.

Background Clinical manifestations of sarcoidosis vary widely, depending on the intensity of the inflammation and the organ systems affected. So far, no curative treatment exists; the disease can only be suppressed. All treatment options cause side effects affecting quality of life. The aim of this study was to establish and rank the prevalence of self-reported gastrointestinal side effects of drugs used in the treatment of sarcoidosis. Methods A cross-sectional web-based anonymous survey about complaints and side effects was conducted among sarcoidosis patients in the Netherlands, United Kingdom, and United States of America. Results Of the participants, 70% were being treated with one or more drugs. The most important reported side effect was weight gain, associated with increased appetite among prednisone users (as monotherapy as well as in combination with other drugs). Methotrexate (MTX) users especially experienced nausea, with monotherapy as well as combination therapy. Vomiting and weight loss were most prominent among azathioprine and mycophenolate mofetil (MMF) users, whereas diarrhoea was frequently mentioned by MMF and MTX users. The reported side effects of hydroxychloroquine were generally rather mild. Conclusion The current study ranked the gastrointestinal side effects associated with pharmacotherapy in sarcoidosis patients. Pharmacotherapy does have multiple gastrointestinal side effects. The strongest association between a reported side effect and drug use was that of weight gain associated with increased appetite among prednisone users. It would therefore be useful for future research to look further into dietary interventions to counter these side effects and reduce their burden.

Background and Purpose The flavonoid quercetin increased the in vitro potency of the alpha(1)-antagonist tamsulosin to reduce phenylephrine-dependent arterial contractions by 10-fold. To examine if this supplement-drug interaction luxates hypotensive and orthostatic events in vivo, several set of studies were conducted in spontaneously hypertensive (SHR) and normotensive (Wistar Kyoto [WKY]) rats.Experimental Approach First, in rats pretreated with quercetin or its vehicle, responses to phenylephrine and tamsulosin were examined. Second, tamsulosin-induced changes in renal, mesenteric, hindquarter and carotid conductance were compared in quercetin- and vehicle-treated rats instrumented with Doppler flow probes. Animals were also placed on a tilt table to record regional haemodynamic changes to orthostatic challenges. Third, adult SHR were instrumented with telemeters to measure 24-hr patterns of BP. Recordings were made before and during a 5-week oral treatment of quercetin. Finally, pre-hypertensive SHR were treated with quercetin from 4 to 8 weeks of age and arterial pressure was measured at 8 and 12 weeks.Key Results Pretreatment with quercetin did not influence the responses to phenylephrine and tamsulosin, in neither WKY nor SHR. While tamsulosin treatment and tilting lowered BP and increased conductance in all vascular beds, effect size was not influenced by pretreatment with quercetin. Prolonged treatment with quercetin, in either prehypertensive SHR or adult SHR with established hypertension did not lower BP.Conclusions and Implications Cumulatively, these data demonstrate that quercetin does not amplify haemodynamic effects of tamsulosin or tilting in vivo in rats and has no effect on BP development in SHR.

Background Quality indicators (QIs) are measurable elements of practice performance and may relate to context, process, outcome and structure. A valid set of QIs have been developed, reflecting the clinical reasoning used in primary care physiotherapy for patients with whiplash-associated disorders (WAD). Donabedian’s model postulates relationships between the constructs of quality of care, acting in a virtuous circle. Aim To explore the relative strengths of the relationships between context, process, and outcome indicators in the assessment of primary care physiotherapy in patients with WAD. Materials and Methods Data on WAD patients (N=810) were collected over a period of 16 years in primary care physiotherapy practices by means of patients records. This routinely collected dataset (RCD-WAD) was classified in context, process, and outcome variables and analyzed retrospectively. Clinically relevant variables were selected based on expert consensus. Associations were expressed, using zero-order, as Spearman rank correlation coefficients (criterion: rs >0.25 [minimum: fair]; α-value = 0.05). Results In round 1, 62 of 85 (72.9%) variables were selected by an expert panel as relevant for clinical reasoning; in round 2, 34 of 62 (54.8%) (context variables 9 of 18 [50.0%]; process variables 18 of 34 [52.9]; outcome variables 8 of 10 [90.0%]) as highly relevant. Associations between the selected context and process variables ranged from 0.27 to 0.53 (p≤0.00), between selected context and outcome variables from 0.26 to 0.55 (p≤0.00), and between selected process and outcome variables from 0.29 to 0.59 (p≤0.00). Moderate associations (rs >0.50; p≤0.00) were found between “pain coping” and “fear avoidance” as process variables, and “pain intensity” and “functioning” as outcome variables. Conclusion The identified associations between selected context, process, and outcome variables were fair to moderate. Ongoing work may clarify some of these associations and provide guidance to physiotherapists on how best to improve the quality of clinical reasoning in terms of relationships between context, process, and outcome in the management of patients with WAD., Video abstract Point your SmartPhone at the code above. If you have a QR code reader the video abstract will appear. Or use: https://youtu.be/J5N9cYF3BW4

BackgroundCultured meat – animal meat produced with the help of tissue engineering techniques – is proposed as a solution to the adverse effects of the meat producing industry and its environmental impact. Only limited research has briefly touched upon safety and regulatory aspects of cultured meat. Scientific evidence demonstrating that a food does not pose a safety risk to human health is essential according to European legislation. Therefore, the present study aims to establish what the barriers and drivers are of a safe market introduction of cultured meat.Scope and approachA qualitative, exploratory approach is used with semi-structured in-depth interviews in three groups of stakeholders: regulatory experts, scientific experts and industrial representatives (total N = 15).Key findings and conclusionsCertain areas of cultured meat research require more attention from researchers to ensure the highest level of safety. Overall, the lack of in-depth research related to hazard and risk characterisation of cultured meat is considered the biggest barrier in introducing a safe product to the market. We call for changing the research emphasis towards a safety-oriented approach to ensure the highest level of safety possible.

Background Physical activity may be a way to increase and maintain fat-free mass (FFM) in later life, similar to the prevention of fractures by increasing peak bone mass. Objectives A study is presented of the association between FFM and physical activity in relation to age. Methods In a cross-sectional study, FFM was analyzed in relation to physical activity in a large participant group as compiled in the International Atomic Energy Agency Doubly Labeled Water database. The database included 2000 participants, age 3–96 y, with measurements of total energy expenditure (TEE) and resting energy expenditure (REE) to allow calculation of physical activity level (PAL = TEE/REE), and calculation of FFM from isotope dilution. Results PAL was a main determinant of body composition at all ages. Models with age, fat mass (FM), and PAL explained 76% and 85% of the variation in FFM in females and males

The Common Fisheries Policy of the European Union was reformed in 2013 with the aim of improving the sustainability of the fishing sector. The Landing Obligation, a cornerstone of this reform, requires fishers to land their unwanted catch instead of discarding it at sea. Existing literature pays little attention to what becomes of this unwanted catch once it is landed. To further the discourse on the sustainable valorisation of unwanted catch, this study explores whether unwanted catch that is safe for human consumption could be used for improving food security. The paper focuses on Dutch food banks, which deliver critical food aid to over 160,000 individuals yearly but struggle to provide all dependant recipients with nutritionally balanced food parcels. The research question is addressed in two ways. The food bank recipients’ willingness to consume UWC is evaluated quantitatively through a survey. Next to this, data from interviews with relevant stakeholders are analysed qualitatively. Results indicate that the Food Bank Foundation and its recipients are willing to receive this fish if it is safe to consume and accessible. However, various factors such as existing infrastructure, lack of economic incentive to donate, competition from non-food and black markets, and the fishing industry’s conflict with the landing obligation might pose barriers to this kind of valorisation. The dissonance between fisheries, food, and sustainability policies is discussed and identified as a key limiting factor. To bridge the differences between these policy areas, we propose public-private partnerships and voluntary agreements among involved stakeholders.

Background Combined lifestyle interventions (CLIs) are designed to help people who are overweight or obese maintain a healthy new lifestyle. The CooL intervention is a CLI in the Netherlands, in which lifestyle coaches counsel adults and children (and/or their parents) who are obese or at high risk of obesity to achieve a sustained healthier lifestyle. The intervention consists of coaching on lifestyle in group and individual sessions, addressing the topics of physical activity, dietary behaviours, sleep, stress management and behavioural change. The aim of this study was to evaluate the implementation process of the Coaching on Lifestyle (CooL) intervention and its facilitating and impeding factors. Methods Mixed methods were used in this action-oriented study. Both quantitative (number of referrals, attendance lists of participants and questionnaires) and qualitative (group and individual interviews, observations, minutes and open questions) data were collected among participants, lifestyle coaches, project group members and other stakeholders. The Consolidated Framework for Implementation Research was used to analyse the data. Results CooL was evaluated by stakeholders and participants as an accessible and useful programme, because of its design and content and the lifestyle coaches’ approach. However, stakeholders indicated that the lifestyle coaches need to become more familiar in the health care network and public sectors in the Netherlands. Lifestyle coaching is a novel profession and the added value of the lifestyle coach is not always acknowledged by all health care providers. Lifestyle coaches play a crucial role in ensuring the impact of CooL by actively networking, using clear communication materials and creating stakeholders’ support and understanding. Conclusion The implementation process needs to be strengthened in terms of creating support for and providing clear information about lifestyle coaching. The CooL intervention was implemented in multiple regions, thanks to the efforts of many stakeholders. Lifestyle coaches should engage in networking activities and entrepreneurship to boost the implementation process. It takes considerable time for a lifestyle coach to become fully incorporated in primary care. Trial registration NTR6208; date registered: 13–01-2017; retrospectively registered; Netherlands Trial Register.

The efficacy of botanicals in medicines can be substantiated with evidence on traditional use, whereas in foodstuffs, this is often not possible. In Europe, for example, the evaluation and subsequent authorization of health claims on herbal dietary supplements (HDS) have been put on hold by the European Commission. This study aims to analyze the role of evidence on traditional use in international legal frameworks of foods and pharmaceuticals. Both legal sources as well as scientific studies offering insights into these regulatory frameworks were included into the analysis. The international approach toward evidence on traditional use for substantiating efficacy of botanicals varies highly. For herbal medicines, substantiating efficacy with evidence on traditional use is possible in all studied jurisdictions, except for Japan and the United States. HDS efficacy can only be substantiated with evidence on traditional use in India and New Zealand, although the enforcing authorities do not describe which data are required. Australia and Canada regulate botanicals in a separate "borderline" category from foods and pharmaceuticals. Both jurisdictions allow for substantiating efficacy with evidence on traditional use. This study's second objective was to assess the applicability of the international approaches in the European legal framework, in light of the ongoing political debate regarding the use of traditional evidence. Implementation of the analyzed international approaches would require major revisions of the current European legal framework. This review of international approaches might, however, aid in deciding upon future approaches for substantiating health claims with evidence on traditional use.

Background: Pulmonary arterial hypertension (PAH) is a rare, progressive disease of the pulmonary vasculature. Recent advances in pharmacotherapy improved life expectancy of PAH patients and, thus, signified the role of general measures, including diet, in the management of the disease.Methods: In the present narrative review we will briefly summarize information about current and novel PAH therapies and analyze preclinical evidence on the influence of certain nutrients on the pathogenesis of PAH.Results: Although the evidence on the role of dietary deficiencies in the development and progression of PAH in humans is limited, preclinical studies demonstrate that dietary components such as quercetin, genistein, n-3 PUFAs, vitamin D, coenzyme Q10 and resveratrol may influence various aspects of PAH pathobiology.Conclusions: Further research on the role of diet in PAH is needed. Taking into account pleiotropic and subtle effects of dietary constituents as well as the rare and severe nature of PAH, clinical studies on the disease-specific nutritional patterns rather than on single dietary components may help to reveal if diet can be an important tool to improve the efficacy of pharmacotherapy in PAH. (C) 2019 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

The objective of this study was to investigate the efficacy of lipid emulsions encapsulated in calcium-alginate beads in reducing food intake and appetite sensations. These emulsion-alginate beads were ingested in a yogurt (active) and compared to an equienergetic yogurt containing nonencapsulated nutrients with comparable sensory properties (control) in a randomized placebo-controlled trial with crossover design. Thirty-three healthy overweight volunteers (mean age: 43 years; body mass index: 27.7 kg/m(2); 14 male) received the 2 treatments. Test days started with a standardized small breakfast (t = 0) followed by an active or control yogurt (t = 90 minutes). Appetite sensations and gastrointestinal symptoms were monitored prior to and after consumption of the yogurt, and food intake was measured during ad libitum pasta meal consumption (t = 210 minutes). The hypothesis for this study was that delayed release of encapsulated lipids suppresses appetite sensations and reduces food intake. Food intake was significantly reduced with 51 +/- 20 kcal (213 +/- 84 kJ) (P =.016) after intake of the active yogurt (770 +/- 38 kcal (3222 +/- 159 kJ)) compared to the control (821 +/- 40 kcal (3435 +/- 167 kJ)). The approach that we chose is promising to reduce food intake and could contribute to the development of an easy-to-use product for weight management. (C) 2018 Elsevier Inc. All rights reserved.

Consumers of dietary supplements should be made aware of the benefits and risks of these products. This case study therefore aimed to identify the content of the risk-benefit information provided during the purchase of St. John’s wort supplements and how consumers perceive this information. Fifteen participants visited a shop to purchase St. John’s wort supplements after which they were interviewed on the provided information during the visit. This case study shows that the spontaneous information provision is not consistent in Dutch drugstores and health food shops. The provided information was either very detailed, or no information was given at all. The perceived reliability of information was mainly determined by the authority of the employee and the type of shop where the product was purchased. Information consistency at the moment of purchase is of influence in the perceived value of it.

Food businesses in the European Union are preparing for a carbon-neutral future by gradually transitioning to a circular way of operating. Building upon results from the EU REFRESH project, we consider the most valuable food processing by-streams in Europe and discuss potential food safety risks that must be considered while valorizing them for human consumption. These risks are weighed against the nutritional benefits offered by these products and their potential applications in food supply chains. Broadly, we examine whether it is possible for spent grains, cheese whey, fruit and vegetable scraps, meat processing waste, and oilseed cakes and meals to be safe, sustainable, and nutritionally valuable at the same time. The discussion highlights that valorizing by-products obtained from food processing operations is feasible on a large scale only if consumers deem it to be a safe and acceptable practice. Extracting valuable compounds from by-products and using them in the preparation of functional foods could be a way to gain consumer acceptance. Furthermore, we find that current EU food safety legislation does not sufficiently accommodate food processing by-products. A way to bridge this regulatory gap could be through the adoption of private food safety standards that have shown proclivity for sustainability-related issues in food supply chains. Finally, by proposing a decision tree, we show that it is indeed feasible for some food processing by-products to be valorized while ensuring sustainability, food safety, and nutritional relevance.

Background Overweight and obesity are problems that are increasing globally in both children as well as adults, and may be prevented by adopting a healthier lifestyle. Lifestyle coaches counsel overweight and obese children (and their parents) as well as adults in initiating and maintaining healthier lifestyle behaviours. It is currently unclear whether this novel professional in the Dutch health care system functions as a linchpin in networks that evolve around lifestyle-related health problems. The aim of the present study is to investigate the formation and development of networks of lifestyle coaches and their positions within these networks. Methods In this longitudinal study, key professionals and professionals within relevant organisations in the Coaching on Lifestyle (CooL) care networks were asked to fill in three online questionnaires. Respondents were asked to indicate whether they collaborated with each of the specified professionals in the context of CooL. The overall network structures and the central role of the lifestyle coaches were examined by using network analysis. Results The results showed that the networks in three out of four regions were relatively centralised, but that none of the networks were dense, and that the professionals seemed to collaborate less with others over time. Half of the lifestyle coaches had a high number of collaborations and a central position within their networks, which also increased over time. In half of the regions, the lifestyle coaches had increased their role as consultants, while their role as gatekeeper and liaison decreased over time. In most regions, the sector of lifestyle coaches had a central position in their networks in just one measurement. Other central sectors were the local sports organisation, public health services, youth health care and the municipal government. Conclusions Overall, we cannot conclude that more central and denser networks were formed during the study period. In addition, the lifestyle coaches were not often positioned as a central sector within these networks. Entrepreneurial, network and brokering competences are required for lifestyle coaches to build up denser networks. Trial registration NTR6208; date registered: 13–01-2017; retrospectively registered; Netherlands Trial Register.

Combined lifestyle interventions (CLIs) that target both physical activity (PA) and diet have been shown to improve PA and health of adults who are overweight; however, optimal amount of guidance remains unclear. This study evaluated the effects of adding PA group sessions to a standard CLI in primary care in the Netherlands. 411 participants (BMI 34.5 ± 4.4 kg/m2) in thirty locations were randomised into a one year CLI or CLI+. CLI comprised individual meetings with lifestyle coach (LSC) and physiotherapist, and group meetings with dietician. PA group sessions were added in CLI+. Primary outcome was minutes of moderate to vigorous PA per week. Secondary outcomes of PA, diet and cardiovascular risk factors (i.e. waist circumference, HbA1c and blood pressure) were evaluated after 12 and 24 months with multilevel analyses. Data were collected from 2010 to 2015. Significant between-group effects were only found for waist circumference, which was significantly lower at twelve months in the CLI+ group (p = 0.011), no other between-group differences were found. Several within-group changes were significant. After participating in the intervention, walking time increased with 83 ± 35 min/week and 100 ± 38 min/week, and BMI decreased with 0.7 ± 0.3 kg/m2 and 1.5 ± 0.3 kg/m2 in CLI and CLI+ respectively (p < 0.001). Diet, HbA1c and systolic blood pressure changed favourably in both groups. Adding PA group sessions did not elicit added, sustained benefits. A programme with individual meetings with LSC and physiotherapist, and group meetings with dietician can be sufficient to facilitate a healthy lifestyle and reduce cardiovascular risk factors in a population with overweight.

The 90-day toxicity study is one of the studies used in the safety assessment of food ingredients, medicines or other chemical substances. This paper reviews the current role of the 90-day oral toxicity study in European regulatory dossiers of chemicals by reviewing EU legislation and EU and OECD guidance documents. Regulatory provisions with regard to necessity, objectives and design of such 90-day toxicity studies vary between the different sectors addressed in this review. Most often the 90-day study is expected to be part of the standard test battery used for chemical risk assessment, without necessarily being a legal requirement and its objectives may vary between regulatory domains. Exceptions, when a 90-day study is not required are spelled out in the chemicals legislation and for food contact materials. The sectorial study design requirements of the 90-day toxicity study are very often embedded in the OECD TG 408 protocol. Differences in study objectives are not necessarily reflected in specific study designs. Considering the call for the reduction of using experimental animals for scientific purposes and the fact that a 90-day study may serve different purposes, consistency between the necessity to conduct such a study, its objectives and the study design to achieve these objectives may improve judicious use of laboratory animals. Thus there may be an opportunity to reflect and further optimise the design of in vivo toxicology studies, such as the 90-day study. This should be based on a systematic analysis of past studies and risk assessments.

Rob AB Oostendorp,1– 4 JW Hans Elvers,5,6 Emiel van Trijffel,7,8 Geert M Rutten,9,10 Gwendolyne GM Scholten-Peeters,11 Marcel Heijmans,4 Erik Hendriks,12,13 Emilia Mikolajewska,14,15 Margot De Kooning,3,16 Marjan Laekeman,17,18 Jo Nijs,3,16,19 Nathalie Roussel,20 Han Samwel21 1Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands; 2Department of Manual Therapy, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Brussels, Belgium; 3Pain in Motion International Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; 4Practice Physiotherapy and Manual Therapy, Heeswijk-Dinther, the Netherlands; 5Department of Public Health and Research, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands; 6Department of Allied Health Care, Methodological Health-Skilled Institute, Beuningen, the Netherlands; 7Department of Master Education, SOMT University of Physiotherapy, Amersfoort, the Netherlands; 8Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; 9Institute of Health Studies, Faculty of Health and Social Studies, HAN University of Applied Science, Nijmegen, the Netherlands; 10Campus Venlo, Faculty of Science and Engineering, Maastricht University, Maastricht, the Netherlands; 11Department of Human Movement Sciences, Faculty of Behavioral and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands; 12Department of Epidemiology, Center of Evidence Based Physiotherapy, Maastricht University, Maastricht, the Netherlands; 13Practice Physiotherapy ‘Maasstaete, Druten, the Netherlands; 14Department of Physiotherapy, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń, Poland; 15Neurocognitive Laboratory, Centre for Modern Interdisciplinary Technologies, Nicolaus Copernicus University, Toruń, Poland; 16Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium; 17Department of Nursing Sciences, Ph.D.-Kolleg, Faculty of Health, University Witten/Herdecke, Witten, Germany; 18Department of Physiological Psychology, University of Bamberg, Bamberg, Germany; 19Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden; 20Department of Physiotherapy and Rehabilitation Sciences (MOVANT), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium; 21Revalis Pain Rehabilitation Centre, S Hertogenbosch, the NetherlandsCorrespondence: Rob AB OostendorpScientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, p/a Oude Kleefsebaan 325, AT Berg En Dal 6572, Nijmegen, the NetherlandsTel +31 246423419Email oostendorp.rob@gmail.comBackground: Whiplash-associated disorders (WADs) constitute a state of health characterized by a wide diversity of symptoms as a result of impairments of functions, activity limitations, and participation restrictions. Patient-reported outcome measurements (PROMs) and patient-reported outcomes (PROs) seem appropriate when describing and evaluating the health status of patients with WAD.Aim: To measure the use of PROMs and PROs as quality indicators in clinical reasoning, and to analyze and evaluate pre- and post-treatment ‘pain intensity’ and ‘functioning’, and for ‘perceived improvement’ in patients with WAD in primary care physiotherapy practice by year of referral, with the phase after accident and prognostic health profile embedded in the clinical reasoning process.Materials and Methods: Data were collected over a period of 10 years. Pain intensity, functioning, and perceived improvement were measured using the Visual Analogue Scale for Pain (VAS-P), the Neck Disability Index (NDI) and the Global Perceived Effect scale (GPE). Pre- and post-treatment mean differences were tested for statistical significance and compared to minimal clinically important differences (MCID). Effect sizes were expressed as Cohen’s d. Multivariable regression analysis was performed to explore independent associations of year of referral, phase after the accident, and the patient’s prognostic health profile with post-treatment pain intensity and functioning.Results: A consecutive sample of 523 patients was included. Pre- and post-treatment mean differences on VAS-P and NDI were statistically significant (P< 0.000) and clinically relevant, with ‘large’ effect sizes for pain intensity and functioning. MCIDs were achieved by 80% for VAS-P and for 60% for NDI. Year of referral and phase after the accident were independently associated with worse post-treatment functioning. About half of the patients (n=241 [46.1%]) perceived themselves as improved.Conclusion: The PROMs and PROs pain intensity, functioning and perceived improvement were integrated as quality indicators in the physiotherapy clinical reasoning process for patients with WAD. Significant differences in pain intensity and functioning were found but were unrelated to year of referral, phase after whiplash-related injury or prognostic health profile. The MCID VAS-P scores did not differ depending on experienced pain.Keywords: whiplash-Associated Disorders, neck pain, physiotherapy, patient-reported outcomes measures, routinely collected data

Safety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a longstanding ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources.This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.

The use of vitamin B6 supplements has gained lots of attention over the past years as they have been related to the development of peripheral neuropathy. The present study focused on the pharmacokinetics of vitamin B6. Twelve healthy volunteers were daily supplemented with either 50 mg pyridoxine or pyridoxal-phosphate for one week. On days 1, 3 and 7, blood samples were taken after oral intake of the supplements. Plasma levels of different vitamers of B6 were determined with ultra-performance liquid chromatography–tandem mass spectrometry. Additionally, reported adverse reactions related to polyneuropathy and vitamin B6 supplements were analyzed. At day 1, pyridoxine only increased after supplementation with pyridoxine during the 4 h analysis. At days 3 and 7, average plasma pyridoxal-phosphate and pyridoxal concentrations significantly increased after supplementation with both vitamers. Average plasma pyridoxine concentrations only significantly increased after 3 and 7 days of supplementation with pyridoxine. Large individual differences in plasma levels of B6 vitamers were seen at all days. Also, individual differences concerning dose and plasma levels were determined in the reported complaints. Our results show that there is a clear inter-individual difference in kinetics of vitamin B6, potentially explaining differences in sensitivity to vitamin B6 toxicity.

Nonsteroidal anti-inflammatory drugs are frequently used by athletes in order to prevent musculoskeletal pain and improve performance. In combination with strenuous exercise, they can contribute to a reduction of renal blood flow and promote development of kidney damage. We aimed to investigate whether monomeric and oligomeric flavanols (MOF) could reduce the severity of kidney injuries associated with the intake of 400-mg ibuprofen followed by the completion of a half-marathon in recreational athletes. In this double-blind, randomized study, the original MOF blend of extracts from grape seeds (Vitis vinifera L.) and pine bark (Pinus pinaster L.) or placebo were taken for 14 days preceding the ibuprofen/half-marathon. Urine samples were collected before and after the ibuprofen/half-marathon, and biomarkers of kidney injury, inflammation and oxidative stress were assessed. Intake of MOF significantly reduced the incidence of post-race hematuria (p = 0.0004) and lowered concentrations of interleukin (IL)-6 in the urine (p = 0.032). Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease. The supplementation with MOF in recreational runners appears to safely preserve kidney function, reduce inflammation and promote antioxidant defense during strenuous exercise and intake of a single dose of ibuprofen.

Drugs are serious but underestimated causative agents of interstitial lung disease (ILD). Both cytotoxic and immune mechanisms may be involved in drug-induced ILD (DI-ILD). We aimed to investigate whether polymorphisms of relevant CYP enzymes involved in the metabolization of tamsulosin might explain the pathologic mechanism of the DI-ILD in the cases with suspected tamsulosin DI-ILD. We collected 22 tamsulosin-associated DI-ILD cases at two ILD Expertise Centers in the Netherlands between 2009 and 2020. CYP2D6, CYP2C9, CYP2C19, CYP3A4, and CYP3A5 single nucleotide polymorphisms were genotyped and compared with a control group of 78 healthy Caucasian male volunteers. Nine cases were phenotyped as CYP2D6 poor metabolizers and 13 as CYP2D6 intermediate metabolizers. The phenotypes of the cases differed significantly from those of the healthy controls, with more poor metabolizers. After withdrawal of tamsulosin, the pulmonary condition of three cases had improved, six patients had stabilized, and one patient stabilized after reducing the tamsulosin dose. The described 22 cases suggest that an association between the presence of CYP2D6 allelic variants and tamsulosin-associated ILD is highly likely. These cases highlight the importance of both clinical and genetic risk stratification aimed to achieve a more accurate prevention of DI-ILD in the future and enhance the quality of life of patients.

This paper explores how UK-based companies deal with their responsibility to respect the human rights of Assam (India) tea plantation workers. Through qualitative content analysis of publicly available corporate reports and other documents, it investigates how companies approach and communicate their potential human rights impacts. It highlights the gap between well-documented human rights issues on the ground and corporate reports on these issues. It aims to answer the following research question: in a context where the existence of human rights violations at the end of the supply chain is well-documented, how do companies reconcile their possible connection with those violations and the corporate responsibility to respect human rights under the United Nations Guiding Principles on Business and Human Rights? This paper reveals the weakness of the current corporate social responsibility (CSR) approach from the perspective of rights-holders. It supports a business and human rights approach, one that places the protection of human rights at its core.Keywords: tea plantations; Assam; business and human rights; corporate social responsibility; UN Guiding Principles on Business and Human Rights; UK Modern Slavery Act

The rejection of many putative health claims in Europe is assumed to have negatively affected functional food innovation. This study analysed the influence of Article 13.1 health claims review procedure on the perception of functional food innovation. The analysis of all scientific opinions related to antioxidants and a subsequent qualitative review of five scientific dossiers reveals that the evaluation by the European Food Safety Authority was not conducted consistently, as the Authority did not follow their own procedure. Several submitted scientific dossiers however also contain studies unrelated to the proposed health claim. By not following their own procedure, the European Food Safety Authority has created uncertainty regarding health claim evaluations. This uncertainty presents a risk for food companies and impacts future investments for research and development of new functional food products. Although published guidance documents have partially clarified the evaluation process, further standardisation and clarification will benefit functional food innovation.

European food laws increasingly use scientific evidence to protect consumers from hazards and to prevent the use of misleading information. In this article, the use of risk assessment in European food law is analysed and the implications of the recently adopted adjustments to the EU's General Food Law are reviewed. The risk analysis cycle that has been implemented in many authorisation decisions of the European Commission has resulted in the increased level of public health protection since 2002. The food law evaluation under REFIT however identified various shortcomings, including the civil societies' perception that various elements of EFSA's work lacked transparency and independence. To deal with these identified issues, the newly adopted regulation will bring about specific adjustments to the General Food Law and sectorial legislation. Although these adjustments are expected to improve European food policies, today's EU food laws should be further enhanced by improving the use of nutritional sciences in food law. Such joint efforts can result in a higher level of consumer protection and further advance the internal European market. Only through improving the systematic way to conduct scientific analyses into and by enhancing their use in risk management, European food law will become more future-proof.

Consumption of dietary supplements and specifically niche products such as supplements targeting pregnant women is increasing. The advantages of dietary supplementation during pregnancy with folic acid have been established, but health effects of many other supplements have not been confirmed. EU and US legislation on dietary supplements requires the product to be safe for the direct consumer, the mother. Long-term health effects for the fetus due to fetal programming (in utero adaptation of the fetal epigenome due to environmental stimuli such as supplementation) are not taken into account. Such epigenetic alterations can, however, influence the response to health challenges in adulthood. We therefore call for both conducting research in birth cohorts and animal studies to identify potential health effects in progeny of supplement consuming mothers as well as the establishment of a nutrivigilance scheme to identify favorable and adverse effects post-marketing. The acquired knowledge can be used to create more effective legislation on dietary supplement intake during pregnancy for safety of the child. Increasing knowledge on the effects of consuming supplements will create a safer environment for future mothers and their offspring to optimize their health before, during and after pregnancy.

Introduction Simvastatin has previously been associated with drug-induced interstitial lung disease. In this retrospective observational study, cases with non-specific interstitial pneumonia (NSIP) or idiopathic pulmonary fibrosis (IPF) with simvastatin-associated pulmonary toxicity (n = 34) were evaluated. Objective To identify whether variations in genes encoding cytochrome P450 (CYP) enzymes or in the SLCO1B1 gene (Solute Carrier Organic anion transporting polypeptide 1B1 gene, encoding the organic anion transporting polypeptide 1B1 [OATP1B1] drug transporter enzyme), and/or characteristics of concomitantly used drugs, predispose patients to simvastatin-associated pulmonary toxicity. Methods Characteristics of concomitantly used drugs and/or variations in the CYP or SLCO1B1 genes and drug–gene interactions were assessed. The outcome after withdrawal of simvastatin and/or switch to another statin was assessed after 6 months. Results Multiple drug use involving either substrates and/or inhibitors of CYP3A4 and/or three or more drugs with the potential to cause acidosis explained the simvastatin-associated toxicity in 70.5% (n = 24) of cases. Cases did not differ significantly from controls regarding CYP3A4, CYP2C9, or OATP1B1 phenotypes, and genetic variation explained only 20.6% (n = 7) of cases. Withdrawal of simvastatin without switching to another statin or with a switch to a hydrophilic statin led to improvement or stabilization in all NSIP cases, whereas all cases who were switched to the lipophilic atorvastatin progressed. Conclusion Simvastatin-associated pulmonary toxicity is multifactorial. For patients with this drug-induced pulmonary toxicity who need to continue taking a statin, switching to a hydrophilic statin should be considered. ClinicalTrials.gov identifier NCT00267800, registered in 2005. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01105-8.

Suggestions that a food contains healthy ingredients or that it can provide beneficial effects upon consumption have been regulated in the EU since 2006. This paper describes the analysis of how this nutrition and health claim regulation has resulted in over 300 authorised claims and how the authorisation requirements and processes have affected the use of claims on foods. Five challenges are identified that negatively affect the current legislation dealing with nutrition and health claims: non-reviewed botanical claims (as well as on hold claims for infants and young children), the lack of nutrient profiles and the focus of claims on single ingredients, consumer understanding, research into health effects of nutrition and finally, enforcement. These challenges are shown to influence the goals of the regulation: protecting consumers from false and misleading claims and stimulating the development of a level playing field in the EU, to foster innovation. Tackling these political and scientific substantiation questions for health claims, together with continuously analysing the understanding and usage of claims by consumers and operators will ensure that the NHCR will stay effective, today and in the future.

Anti-inflammatory treatment in chronic inflammatory lung diseases usually involves glucocorticosteroids. With patients suffering from serious side effects or becoming resistant, specific nutrients, that are suggested to positively influence disease progression, can be considered as new treatment options. The dietary inflammatory index is used to calculate effects of dietary components on inflammation and lung function to identify most potent dietary components, based on 162 articles. The positive effects of n-3 PUFAs and vitamin E on lung function can at least partially be explained by their anti-inflammatory effect. Many other dietary components showed only small or no effects on inflammation and/or lung function, although the number of weighted studies was often too small for a reliable assessment. Optimal beneficial dietary elements might reduce the required amounts of anti-inflammatory treatments, thereby decreasing both side effects and development of resistance as to improve quality of life of patients suffering from chronic inflammatory lung diseases.

Exposure to light at night (LAN) has been associated with serious pathologies, including obesity, diabetes and cancer. Recently we showed that 2 h of LAN impaired glucose tolerance in rats. Several studies have suggested that the autonomic nervous system (ANS) plays an important role in communicating these acute effects of LAN to the periphery. Here, we investigated the acute effects of LAN on the liver transcriptome of male Wistar rats. Expression levels of individual genes were not markedly affected by LAN, nevertheless pathway analysis revealed clustered changes in a number of endocrine pathways. Subsequently, we used selective hepatic denervations [sympathetic (Sx), parasympathetic (Px), total (Tx, i.e., Sx plus Px), sham] to investigate the involvement of the ANS in the effects observed. Surgical removal of the sympathetic or parasympathetic hepatic branches of the ANS resulted in many, but small changes in the liver transcriptome, including a pathway involved with circadian clock regulation, but it clearly separated the four denervation groups. On the other hand, analysis of the liver metabolome was not able to separate the denervation groups, and only 6 out of 78 metabolites were significantly up- or downregulated after denervations. Finally, removal of the sympathetic and parasympathetic hepatic nerves combined with LAN exposure clearly modulated the effects of LAN on the liver transcriptome, but left most endocrine pathways unaffected.Conclusion: One-hour light-at-night acutely affects the liver transcriptome. Part of this effect is mediated via the nervous innervation, as a hepatectomy modulated and reduced the effect of LAN on liver transcripts.

Intraduodenal activity of taste receptors reduces food intake. Taste receptors are expressed throughout the entire gastrointestinal tract. Currently, there are no data available on the effects of distal taste receptor activation. In this study, we investigate the effect of intraduodenal and/or intraileal activation of taste receptors on food intake and satiety. In a single-blind randomized crossover trial, fourteen participants were intubated with a naso-duodenal-ileal catheter and received four infusion regimens: duodenal placebo and ileal placebo (DPIP), duodenal tastants and ileal placebo (DTIP), duodenal placebo and ileal tastants (DPIT), duodenal tastants and ileal tastants (DTIT). Fifteen minutes after cessation of infusion, subjects received an ad libitum meal to measure food intake. Visual analog scale scores for satiety feelings were collected at regular intervals. No differences in food intake were observed between the various interventions (DPIP: 786.6 &plusmn, 79.2 Kcal, DTIP: 803.3 &plusmn, 69.0 Kcal, DPIT: 814.7 &plusmn, 77.3 Kcal, DTIT: 834.8 &plusmn, 59.2 Kcal, p = 0.59). No differences in satiety feelings were observed. Intestinal infusion of tastants using a naso-duodenal-ileal catheter did not influence food intake or satiety feelings. Possibly, the burden of the four-day naso-duodenal-ileal intubation masked a small effect that tastants might have on food intake and satiety.

This article examines an educational experiment with a unique combination of 3 elements: homework, the use of information and communication technology and a large degree of freedom of choice (student autonomy). More particularly, we study the effectiveness of a web-based intelligent tutoring system (ITS) that a school offers to its students as optional homework, in a sample of 355 first-year secondary students, using an experimental design. The results show that whether students make this noncompulsory homework in the web-based ITS is dependent on their prior achievement and their teacher, and if they practice, they tend to choose easier modules. Students thus do not seem to optimize learning gains, but rather balance their perceived value of practicing and their "expectancy," as found previously for regular (compulsory, non-ITS) homework. Regarding the value of choice, findings suggest that students may be poor judges of their most beneficial exercises pattern. Differentiation in ITS does not guarantee learning, unless scaffolding is tightly linked to it. In line with previous research, this research shows that practice does matter, though at varying intensities. Yet it also clarifies that motivation to make an effort is required, which adds to the lessons learned from homework research; both the perceived value and expectancy are at play and can be enhanced, for example, by teachers.

Defining and characterising the active ingredient is the first criterion in reviewing scientific substantiation of health claims by the European Food Safety Authority under the Nutrition and Health Claim Regulation. This study analyses three health claim dossiers where the active ingredient is directly connected to the food item containing the bioactive. Since this bioactive itself is held responsible for the effect, the association of the food item and the bioactive is not always justifiable. This association is shown to be influenced by both the type of claim and the substantiating evidence. We argue that it would be preferable to more precisely chemically define the active ingredients. Claims could then be based on a bioactive constituent without the necessity to connect the claim to a specific matrix, becoming more transparent and relevant to both the industry and consumers. Characterisation and defining the bioactive should therefore be central in the health claim.

Introduction An impediment for the acceptance of Traditional Chinese Medicine (TCM) in the West is that the improper use of some TCM is associated with serious side effects. This is exemplified by Ma Huang Decoction (MHD), a Ma Huang containing TCM formula used to treat asthma. The reported cardiovascular side effects often involve the inappropriate use of Ma Huang in isolation, while in TCM clinical practice Ma Huang is combined with other herbs in MHD to mitigate side effects. The aim of the study was to investigate the potential of Ma Huang as it is used in TCM, explore how it may affect the cardiovascular system and compare this to Ma Huang as it is used in the West. Methods The contractile response of isolated arteries from human placenta to Ma Huang, MHD, and MHD without Ma Huang was used in a bioassay to evaluate their cardiovascular side effects. Results The contractile response by Ma Huang in isolation is much higher than that of Ma Huang in combination with the other herbs in MHD. This confirms that the interplay of the various compounds in MHD may mitigate the side effects of Ma Huang. Previous studies showed that the other herbs in MHD also increase the therapeutic efficacy of Ma Huang. This indicates that the incorrect use of Ma Huang in isolation, and without the supervision of knowledgeable professionals, is likely to be the reasons why the cardiovascular side effects are reported in the West. Conclusion To fully value and appreciate its benefit, TCM should be used appropriately as developed over centuries in China.

Sulphites or sulphiting agents refer to sodium hydrogen sulphite, sodium metabisulphite, potassium metabisulphite, calcium sulphite, calcium hydrogen sulphite, and potassium hydrogen sulphite. As food additives, they are widely used by the food industry with a variety of commercial uses in food and beverages. Sulphites are effective bleaching agents, antimicrobials, oxygen scavengers, reducing agents, and enzyme inhibitors. Wine, beer, dehydrated fruits and vegetables, jam, juice, sugar, processed potatoes, seafood, meat and baked products are some of the food categories in which sulphites are added. S ulphites have been implicated in various health related issues. Asthmatic reactions and some antinutriti onal consequences such the degradation of thiamine (vitamin B 1 ) are adverse reactions associated with sulphites. In many countries, sulphites have been regulated. Sulphites are generally recognized as safe in the USA with some exceptions when using in raw fruits and vegetables. In the European Union sulphites are also controlled, and the permitted amount varies according to the food product.

Background. The role of health broker is a relatively new one in public health. Health brokers aim to create support for efforts to optimise health promotion in complex or even “wicked” public health contexts by facilitating intersectoral collaborations and by exchanging knowledge with different stakeholders. The current study aimed to explore the role of health brokers, by examining the motivational, contextual, and behaviour-related factors they have to deal with. Methods. Fifteen professionals from various backgrounds and from various policy and practice organisations were recruited for a semistructured interview. To structure the interviews, we developed the “Health Broker Wheel” (HBW), a framework we then specified with more details derived from the interviews. Results. We identified seven primary types of behaviour that health brokers need to engage in: recognizing opportunities, agenda setting, implementing, network formation, intersectoral collaboration, adaptive managing, and leadership. Determinants of health brokers’ behaviours were identified and categorised as capability, opportunities, motivation, and local or national contextual factors. Conclusion. The health brokers’ role can be seen as an operational approach and is visualised in the HBW. This framework can assist further research to monitor and evaluate this role, and health promotion practitioners can use it as a tool to implement the health brokers’ role and to facilitate intersectoral collaboration.

Responsible Research and Innovation (RRI) has recently emerged as a new framework for science and technology governance. The concept articulates the need for mutual exchange by which societal actors become responsive to each other early on in the process of innovation, with a view to facilitate ethically acceptable and sustainable innovation. There is relatively limited evidence to explore the extent to which the process of research and innovation under the terms of RRI is realised in practice, particularly in the context of food and health research. Although research to date has been examining innovation from the point of view of inputs and outputs-R&D funding and patents we propose to examine the cognitive framing of innovation that shapes decisions of those who constitute a part of the innovation chain. This paper explores how the concept of innovation is understood and used in policy implementation, with a particular focus upon 'food and health' science and research policy and funding. Our analysis is based on 55 interviews of various actors engaged in research funding decision-making across eight European countries. Three themes emerged from the analysis: concept of innovation; conditions for innovation; and drivers of innovation; through these themes, the cognitive framing was drawn out. The cognitive framing suggests that innovation in the food and health domain is perceived to be focused on biosciences and marketable applications to the neglect of social sciences and broader public interest; that the "innovation network" is primarily viewed as centred around scientific/technical and industrial actors; and that the demand-pull dynamic is relevant to innovation in the area of food and health, despite having been relegated in contemporary thinking and policies around innovation. These findings point to the inadequate consideration of the normative issues how problems are to be defined and addressed among national research funders in the food and health domain, and indicate a gap between the ideas of innovation under the terms of RRI and innovation as conceptualised by those involved in its governance.

BACKGROUND AND AIMS: Probiotics, prebiotics and synbiotics have been suggested as dietary strategies to improve intestinal barrier function. This study aimed to assess the effect of two weeks synbiotic supplementation on intestinal permeability under basal and stressed conditions. Secondary aims were the assessment of two weeks synbiotic supplementation on systemic immune function and gastrointestinal symptoms including defecation pattern.DESIGN: Twenty healthy adults completed a double-blind, controlled, randomized, parallel design study.INTERVENTION: Groups either received synbiotic (1.5 × 1010 CFU Ecologic® 825 + 10 g fructo-oligosaccharides (FOS P6) per day) or control supplements for two weeks.OUTCOMES: Intestinal segment specific permeability was assessed non-invasively by oral administration of multiple sugar probes and, subsequently, assessing the excretion of these probes in urine. This test was conducted at baseline and at the end of intervention, in the absence and in the presence of an indomethacin challenge. Indomethacin was applied to induce a compromised gut state. Plasma zonulin, cytokines and chemokines were measured at baseline and at the end of intervention. Gastrointestinal symptoms and stool frequency were recorded at baseline and daily during intervention.RESULTS: Significantly more male subjects were in the synbiotic group compared to the control group (P = 0.025). Indomethacin significantly increased urinary lactulose/rhamnose ratio versus without indomethacin, both in the control group (P = 0.005) and in the synbiotic group (P = 0.017). Urinary sugar recoveries and ratios, plasma levels of zonulin, cytokines and chemokines, and gastrointestinal symptom scores were not significantly different after control or synbiotic intervention. Stool frequency within the synbiotic group was significantly increased during synbiotic intervention compared to baseline (P = 0.039) and higher compared to control intervention (P = 0.045).CONCLUSION: Two weeks Ecologic® 825/FOS P6 supplementation increased stool frequency, but did not affect intestinal permeability neither under basal nor under indomethacin-induced stressed conditions, immune function or gastrointestinal symptoms in healthy adults.

Combined lifestyle interventions (CLIs) can be effective in reducing weight and improving lifestyle-related behaviours but it is unclear how CLIs can best be implemented in practice in order to achieve sustained lifestyle changes. The Coaching on Lifestyle programme (CooL) is a CLI in the Netherlands, in which professional lifestyle coaches counsel adults and children (and/or their parents) who are obese or at high risk of obesity to achieve a sustained healthier lifestyle. The CooL intervention consists of group and individual sessions addressing the topics of physical activity, dietary behaviours, sleep and stress. Our longitudinal one-group pre-post study aimed to identify lifestyle changes among participants (adults, children and their parents) at 8 and 18 months after initiation. We assessed constructs ranging from motivation and behaviour-specific cognitions to behaviours and health outcomes. Positive and sustained changes among adults were found regarding perceived autonomy, motivation, perceived barriers, lifestyle behaviours, quality of life and weight. Among children and their parents, few improvements were found regarding behaviours and quality of life. CooL has been successful in coaching adult participants towards sustained behavioural change during the intervention period. Mixed results and smaller effect sizes were found for children and their parents.