Health Claims Research Articles

Small-Sized Tomato Pomace: Source of Bioactive Compounds and Ingredient for Sustainable Production of Functional Bread

Tomato processing generates a by-product known as tomato pomace (TP), which contains chemically diverse valuable components such as lycopene, phenols, dietary fibre, proteins, and oil. The aim of this study was to characterize bioactive compounds in small-sized tomato pomace from cherry and date tomatoes and to evaluate the effects of the addition of 10 and 20% (w/w) of tomato pomace flour (TPF) to durum wheat dough for bread production. Bread containing different amounts of TPF was characterized by physical, chemical, nutritional, and sensory characteristics. TPF is an important source of dietary fibre with a total content of approximately 52.3%, of which 5.3% is soluble and 47% is insoluble. It is also a potential source of natural antioxidants and contains remarkable residual levels of both total carotenoids and polyphenols. TPF addition reduced water loss during baking and significantly affected colour parameters and acidity; furthermore, both fortified TPF breads could use these nutrition and health claims and label the breads as “High Fibre”. The “overall” sensory attribute showed similar values in the control and fortified bread samples, suggesting that the overall quality of the bread remained relatively constant, regardless of the percentage of added TPF.

Gastrointestinal fate of proteins from commercial plant-based meat analogs: Silent passage through the stomach, oxidative stress in intestine, and gut dysbiosis in Wistar rats.

Plant-based meat analogs (PBMAs) are common ultra-processed foods (UPFs) included in the vegan/vegetarian diets as presumed healthy alternatives to meat and meat products. However, such health claims need to be supported by scientific evidence. To gain further insight into this topic, two commercial UPFs typically sold as meat analogs, namely, seitan (S) and tofu (T), were included in a cereal-based chow and provided to Wistar rats for 10weeks. A group of animals had, simultaneously, an isocaloric and isoprotein experimental diet formulated with cooked beef (B). In all cases, experimental chows (∼4kcal/g feed) had their basal protein concentration increased from 14% to 30% using proteins from S, T, or B. Upon slaughter, in vivo protein digestibility was assessed, and the entire gastrointestinal tract (digests and tissues) was analyzed for markers of oxidative stress and untargeted metabolomics. Metagenomics was also applied to assess the variation of microbiota composition as affected by dietary protein. Diets based on PBMAs showed lower protein digestibility than those containing meat and promoted an intense luminal glycoxidative stress and an inflammatory intestinal response. The fermentation of undigested oxidized proteins from T in the colon of Wistar rats likely led to formation of mutagenic metabolites such as p-cresol. The presence of these compounds in the animal models raises concerns about the potential effects of full replacement of meat by certain PBMAs in the diet. Therefore, future research might target on translational human studies to shed light on these findings.

Comparison of complications during catheter ablation of atrial fibrillation between radiofrequency and cryoballoon ablation: insights from a nation-wide claims-based database

Abstract Background Few large-scale, real-world studies have compared the safety of radiofrequency (RF) catheter ablations (CA) with that of cryoballoon ablations of atrial fibrillation (AF), especially in east Asian countries. Methods This retrospective, cross-sectional study used a nationwide administrative claims database, to compare complication-incidence rates between patients who underwent RFCA and cryoballoon ablation of AF. We used data from Medical Data Vision Co., Ltd, that is derived from the health claims, Diagnosis Procedure Combination (DPC) system, and flat-fee payment system in Japan. We first extracted hospitalization records with CA with diagnosis of AF. Exclusion criteria were 1) records with diagnoses of atrial flutter or atrial tachycardia, 2) patients aged <20 years old, 3) CA of AF performed other than RFCA or cryoballoon, 4) records with insufficient clinical data, and 5) patients who were prescribed both direct oral coagulants and warfarin. Complications were defined using the following ICD-10 diagnosis codes: major bleeding (I31.9, I97.1, J98.5, J048, J0021); thromboembolism (H342, I24, I269, I740, I741, I744, I748, I749, K550, K868, N280, or T790); ischemic stroke (G45, or I63); cardiac tamponade (I31.9, I97.1, or J98.5); and vascular access complications (hematoma: S701, S801, T140 or T810; and/or pseudoaneurysms: I72.4). Logistic regression analyses were performed to estimate odds ratios and 95% confidence intervals (CI) for major bleeding, systemic thromboembolism, ischemic stroke, and cardiac tamponade. Results Among the 32,797,540 records between June 2011 and August 2020 from 426 hospitals, 41,347 records who underwent CA of AF (Median 68 [60–74] years old, 30.2 % women) were included in the study. A total of 36,729 RFCA (88.8%) and 4,618 cryoballoon ablation (11.2%) cases were included in the cohort. Major bleeding, systemic thromboembolism, ischemic stroke, cardiac tamponade, and vascular access complications occurred in 194 (0.5%), 193 (0.5%), 116 (0.3%), 414 (1.0%) and 115 (0.3%) patients, respectively. As a result of logistic regression analysis, when cryoballoon ablation was used as a reference, RFCA was associated with higher risk of cardiac tamponade (OR 1.54, 95% CI 1.09–2.25, P = 0.02), while it was not associated with higher or lower risk of other complications (major bleeding OR [95% CI ]1.21 [0.77–2.04]; thromboembolism 1.74 [1.03–3.22]; ischemic stroke 1.88 [0.94–4.47]; vascular access complication; 1.00 [0.58–1.87]). Conclusion Compared to cryoballoon ablations, RFCA was associated with higher risk of cardiac tamponade, using nationwide administrative claims database.

Child-targeted foods in the Portuguese market 2024: Nutritional characteristics and claims

Abstract Background Excessive consumption of high-energy products with high saturated fats, sugars, and salt contents, contribute to the prevalence of overweight, obesity and other related diseases in Portugal, especially among children. Children represent a vulnerable group whose food choices are significantly influenced by advertisements and marketing methods that often promote highly palatable and less healthy foods. This study aimed to assess the nutritional characteristics of visually appealing products targeted at children in Portugal and analyse nutritional, health, and other mentions and claims, as well as icons present in the package. The goal is to contribute to the promotion of healthier food choices and inform public health policies. Methods Nutritional information and mentions/claims from child-targeted foods, featuring labels with cartoons and other appealing images, were collect. These were compared with the reference values (RV) of Integrated Strategy for the Promotion of Healthy Eating (EIPAS) and of Directorate-General of Health Label Decoder (RVLD), as well as the limit values (LV) defined by a Portuguese law related to restrictions on food advertising aimed at children. Results 247 products from six categories were monitored. Only 1.2% met the EIPAS RV for sugar and salt evaluated together, while 10.1% complied with the law LV. According to the RVLD, 19.0%, 26.3%, 49.4%, and 0.4% of the products presented high levels of fat, saturates, sugars, and salt, respectively. The majority of the products (68.0%) had one or more types of mentions/claims, predominantly nutritional (64.3%) and all featured one or more icons, with 10.5% being licensed. Conclusions The majority of these pre-packed child-target foods do not have a healthy nutrient profile. In this context, public health actions, namely legislative measures to further regulate food marketing and labeling elements aimed at children along with literacy and product reformulation initiatives are essential. Key messages • The child-targeted food products in the Portuguese market present inadequate nutritional profiles. • Public health actions are needed to promote healthier food choices and protect children from foodborne non-communicable diseases.

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Nationwide trends and incidence of blindness in patients with diabetic retinopathy identified using an age-period-cohort analysis.

To estimate the epidemiologic trends of blindness in patients with diabetic retinopathy (DR) and investigate the age-, period-, and cohort-specific effects on blindness. A total of 2.5 million patients with DR aged 20 years or older were included from the Korean National Health Claims database from 2005 to 2019. Non-proliferative DR/ proliferative DR (NPDR/PDR) cohorts were constructed separately. Participants were identified as having a blindness in at least one eye. The incidence of blindness were calculated using a log-linear Poisson age-period-cohort (APC) analysis model, each effect on blindness were estimated for each study group. The incidence of blindness was 1326.62 per 100,000 in the NPDR group and 3397.57 in the PDR group. The blindness rate sharply decreased after 2011, with annual decreases of 5.6% and 4.4% in the NPDR and the PDR groups, respectively. People born between 1920 and 1930 had the highest overall risk of blindness, with the risk decreasing rapidly after that. For those born after 1980, the risk started to increase in both sexes. Among the APC models, the combination model of age, period, and cohort effects showed the highest explanatory power (0.96). In this nationwide long-term study, blindness in DR was not due to a single epidemiologic cause but rather a combination of biological age, social determinants, and healthcare policies. The increased risk of blindness in individuals in their 20 s and 30 s may even increase in the future and should not be ignored. Therefore, vigilance of younger patients is recommended.

Differences in treatment and outcome of patients with ST- Elevation Myocardial Infarction (STEMI) and Non-STEMI in Germany

Abstract Background ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) are the main diagnoses of acute coronary syndrome (ACS). Although both types of infarction are classed as ACS, the treatment and overall survival rate are different. Methods Health claims data (≈26 million members) were screened for patients with STEMI and NSTEMI from 01/2010 to 12/2018. Patient demographics, hospitalization details, adherence to guideline-directed drug therapy, and survival were assessed. Results The total cohort of acute myocardial infarctions comprised 544,529 patients (mean age 74 (IQR 62 - 82), one third of whom were hospitalized with a STEMI. Patients with STEMI were more likely to be in a life-threatening situation and had higher in-hospital, 30- and 60-day mortality, but better long-term survival. Major adverse cardiac and cerebrovascular events (MACCE), infarct recurrence, chronic kidney disease, peripheral arterial disease, heart failure and cerebrovascular disease were more common in patients with NSTEMI. STEMI-patients received coronary angiography and percutaneous coronary intervention more frequently. Although there was a clear correlation between guideline-compliant therapy and overall survival, adherence to guideline-compliant therapy decreased over time, especially in NSTEMI patients. Conclusion In ACS patients, there are clear differences between STEMI and NSTEMI patients in terms of short- and long-term survival. Guideline-based therapy improved long-term survival in both, but more significantly in STEMI patients.

Real-world evidence supports superior efficacy of prasugrel over ticagrelor in individuals with acute coronary syndrome

Abstract Background In patients with acute coronary syndrome (ACS) undergoing invasive treatment, ticagrelor and prasugrel are guideline-recommended P2Y12 receptor inhibitors. Preference for one of the two drugs is under debate although the ISAR-REACT5 trial revealed advantages for prasugrel. This real-world data study evaluated the efficacy and safety of ticagrelor versus prasugrel in individuals with ACS undergoing invasive treatment by emulating a target trial analogous to ISAR-REACT5. Methods Following the Population, Intervention, Comparator, Outcome, and Timing (PICOT) framework, within a German health claims database, we adapted the inclusion and exclusion criteria from ISAR-REACT5 and identified a 1:1 propensity score-matched cohort with ACS being treated after hospital discharge with either ticagrelor or prasugrel (n=9,380, each). End points were defined as in ISAR-REACT5 at 1-year follow-up. Additionally, subgroup analyses of individual ACS components ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI) and unstable angina (UA) were conducted. Results The primary composite end point occurred in 9.2% of ticagrelor and 7.4% of prasugrel treated individuals (hazard ratio 1.22; 95% confidence interval 1.10-1.35). Likewise, the secondary end points MI and stroke occurred significantly more often in the ticagrelor arm. All-cause mortality, stent thrombosis, and the safety end point bleeding revealed no significant differences. Subgroup analysis revealed superiority for prasugrel particularly in individuals with STEMI. Statistically, test results and hazard ratios of this real-world data study were in agreement with the findings of ISAR-REACT5. Conclusions With over four times the cohort size of ISAR-REACT5, this study indicates superior efficacy of prasugrel over ticagrelor in individuals with ACS undergoing invasive strategy.Cumulative incidence of primary endpointGraphical abstract

Consumers’ perception and willingness to pay for hydroponic tomatoes: the effects of sustainability and quality attributes

PurposeThe agricultural sector is facing pressure due to concerns about its impact on the environment. Farmers must adapt to ensure high-quality, sustainable production. This requires efficient techniques such as soilless farming. The development of agricultural innovations depends on social acceptance; thus, it is crucial to identify the factors that influence consumers' purchasing decisions. The aim of this paper is to analyse consumers' perceptions of hydroponic cultivation techniques and their willingness to pay (WTP) a premium price for hydroponic tomatoes certified as “nickel-free” and “zero-residue”.Design/methodology/approachThe survey was conducted in Italy using tomatoes as a case study. Data were collected through an online questionnaire from a convenience sample of 292 respondents and were analysed using statistical analysis and a multiple linear regression model.FindingsThe results showed that WTP was influenced by frequency of purchase, familiarity with soilless technology, environmental sustainability, income and education. Consumers place a high value on the sustainability of the hydroponic production process and their perception of increased safety positively influences WTP. It is therefore recommended that marketing strategies focus on the environmental sustainability and safety of hydroponic products. In addition, it may be beneficial to implement a certification system specific to hydroponic cultivation, in addition to the existing “nickel-free” and “zero-residue” certifications.Originality/valueThis study introduces several novel elements: it is the first to assess the Italian consumers’ perceptions and WTP for a hydroponic product. Secondly, it assesses WTP in relation to several aspects of increasing relevance related to health claims, namely “nickel-free” and “zero-residue”.

Healthiness of Meat-Based Products in Comparison to Their Plant-Based Alternatives in the UK Market: A Packaging Evaluation

This study evaluated the healthiness of meat products (n = 62) and their plant-based (PB) counterparts (n = 62) available in the UK market. Back-of-pack (BoP) and front-of-pack (FoP) nutrition label information, nutrition and health claims, and nutrient profiling model scores were compared. BoP labels revealed that meat products had higher protein, fat, and saturated fat content (p = 0.029), whilst PB alternatives were higher in dietary fibre and carbohydrates (p < 0.001). Red colour coding (FoP) for fat and saturated fat (‘high’) was more prominent in meat products (23 and 35%, respectively), and the red meat category had the most products with high fat and saturated fat content. Only 15% of meat products made nutrition claims compared to 40% of PB alternatives, and none included health claims. Most red meat PB alternatives made a nutrition claim, all related to the protein content (34%). The nutrient profiling model indicated that 74% of the PB alternatives were ‘healthy’ compared to 60% of the meat products. No association was found between the product type (meat/PB) and healthiness, except for the red meat products, which showed a significant negative association (p = 0.005), suggesting that these products corresponded to less healthy options. Therefore, PB alternatives can be considered as healthier substitutes for meat products.

Psychiatric Health, Life Skills, and Opportunities for Wellness Program: Addressing psychiatric need through integrated consultation, collaboration, and brief episodes of care.

Integrated behavioral health programs bring strong benefits to patients and health organizations including reductions in overall costs. However, obstacles to funding prevent the implementation and maintenance of these programs across the country. The Psychiatric Health, Life Skills and Opportunities for Wellness (PHLOW) Program is based on the collaborative care model and seeks to provide psychiatric care through an integrated model that is financially sustainable for the organization. This pilot observational study included patients who received psychiatric care indirectly via consultations with primary care providers and directly through brief episodes of care. Patient outcomes were demonstrated by score changes on the nine-item Patient Health Questionnaire and Generalized Anxiety Disorder 7 before and after participation in brief episodes of care. Overall cost of care savings was demonstrated through change over time in risk-adjusted per-member-per-month. Patients participating in the PHLOW program showed potential drops in anxiety and depression ratings, coinciding with a reduction in mental health claims. In addition, participation in the program involved a small number of patient visits and prevented referrals to long-term psychiatry, preserving access for higher acuity presentations. This demonstration of the value of the PHLOW program has led to additional financial support of the program through the primary regional Medicaid payor, enhancing sustainability, and potentially modeling a collaboration that may be feasible for other organizations implementing integrated behavioral health programs. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Antioxidants: A Hot Controversy Defused by Cool Semantics.

Recent years have witnessed a rather controversial debate on what antioxidants are and how beneficial they may be in the context of human health. Despite a considerable increase in scientific evidence, the matter remains highly divisive as different pieces of new data seem to support both the pro- and the anti-antioxidant perspective. Here, we argue that the matter at the heart of this debate is not necessarily empirical but of semantics. Thus, the controversy cannot be resolved with the traditional tools of natural sciences and by the mere accumulation of new data. In fact, the term "antioxidants" has been part of the scientific language game for a few decades and is nowadays used differently in the context of different scientific disciplines active at different levels of scientific complexity. It, therefore, represents not a single expression but an entire family of words with distinctively different connotations and associations. The transcendent use of this expression from a basic to a more complex discipline, such as going from chemistry to physiology, is problematic as it assigns the term with connotations that are not corroborated empirically. This may lead to false claims and aspirations not warranted by empirical data. Initially, health claims may not even be indented, yet, on occasion, they are welcome for reasons other than scientific ones. To resolve this debate, one may need to refrain from using the term "antioxidants" in disciplines and contexts where its meaning is unclear, limit its use to disciplines where it is essential and beneficial, and, in any case, become more specific in such contexts where its use is warranted, for instance, in the case of "dietary antioxidants".

Disclosure of mandatory and voluntary nutrition labelling information across major online food retailers in the USA.

Nutrition labelling is mandatory on food products in retail stores, but compliance in the rapidly expanding online setting remains unclear. We assessed mandatory and voluntary labelling information across major U.S. online retailers. Between January and August 2022, we evaluated a representative basket of sixty food and beverage items across eight product categories of ten major retailers. We evaluated online presence, accessibility and legibility of four mandatory elements - Nutrition Facts, ingredients, allergen statements and percent juice for fruit drinks - and presence of seven voluntary elements - nutrient content claims, health/qualified health claims, ingredient claims, structure-function claims, additive claims, front-of-package nutrient profiling symbols and other marketing claims. Major online food retailers in the USA. N/A. On average, each mandatory element was present, accessible and legible for only 35·1 % of items, varying modestly by element (from 38·3 % for ingredients lists to 31·5 % for Nutrition Facts) but widely by retailer (6·6-86·3 %). Voluntary elements were present for 45·8 % of items, ranging from 83·7 % for marketing claims to 2·0 % for structure-function claims. Findings were generally consistent across the eight product categories. Voluntary elements were more frequently present than accessible and legible mandatory elements for six of ten retailers and seven of eight product categories. Mandatory nutrition label elements are not commonly present, accessible and legible in online retail settings and are less consistently present than marketing elements. Coordinated industry and regulatory actions may be needed to ensure consumers can access mandatory nutrition information to make healthy and safe food choices online.

Association between preterm birth and asthma and atopic dermatitis in preschool children: a nationwide population-based study

Asthma and atopic dermatitis (AD) are representative chronic diseases in childhood. This study aimed to investigate the impact of preterm birth on the incidence and severity of asthma and AD in children, as well as to identify neonatal risk factors for asthma and AD. We used health claims data recorded between 2007 and 2014 in the Korean National Health Insurance Service database. We recruited 2,224,476 infants born between 2007 and 2014 and divided them into three groups: 3518 of extremely preterm (EP) infants (< 28 weeks of gestational age (GA)), 82,579 of other preterm (OP) infants (28–36 weeks of GA), and 2,138,379 of full-term (FT) infants (> 37 weeks of GA). We defined asthma as > 3 episodes of clinical visits in a year before 6 years of age, early asthma as onset at < 2 years of age, and severe asthma as > 1 event of status asthmaticus or admission to a hospital via an emergency room. AD was defined as ≥ 3 diagnoses in a year before 6 years of age, early AD as onset at < 2 years of age, and severe AD as prescription of high-potency topical steroids or immunosuppressants. An association of preterm birth with asthma and AD was assessed using inverse probability of treatment-weighted multivariable Cox regression analysis. Cardiorespiratory conditions, such as respiratory distress syndrome, bronchopulmonary dysplasia, patent ductus arteriosus, and pulmonary hypertension, significantly increased the risk of asthma. Specifically, bronchopulmonary dysplasia emerged as a significant risk factor for both severe and early-onset asthma (odds ratio (OR) 1.36, 95% CI 1.21–1.37 for severe asthma; OR 1.55, 95% CI 1.30–1.85 for early asthma), while it was associated with a decreased risk of AD (OR 0.86, 95% CI 0.80–0.92). Neonatal sepsis, jaundice, and retinopathy of prematurity were also identified as significant risk factors for later asthma. A stepwise increase in the risk of asthma with an increasing degree of prematurity was observed, with the OP group showing an adjusted hazard ratio (aHR) of 1.24 (95% CI: 1.22–1.26) and the EP group showing an aHR of 1.51 (95% CI: 1.41–1.63). Conversely, preterm birth was inversely associated with the risk of AD, with aHRs of 0.73 (95% CI: 0.67–0.79) for the OP group and 0.88 (95% CI: 0.87–0.89) for the EP group. Conclusion Preterm children have a significantly higher risk of asthma and lower risk of AD, with cardiorespiratory conditions significantly increasing the risk of asthma. Thus, we highlight the need for targeted respiratory management strategies for this high-risk population.What is Known:•Asthma and atopic dermatitis are prevalent chronic diseases in childhood, reducing the quality of life of children.•Preterm birth was associated with an increased risk of asthma, but few large nationwide studies.•Research on the relationship between preterm birth and pediatric atopic dermatitis is controversial, with few large nationwide studies.What is New:• Preterm children, especially born before 28 weeks of gestational age, had a significantly higher risk of asthma and lower risk of atopic dermatitis.• Cardiorespiratory comorbidities such as RDS, BPD, PDA, and pulmonary hypertension in neonatal period are prominent risk factors for asthma.• Preterm children are vulnerable to both early-onset and severe asthma.

Consensus Statement on the Outcome of the European Herbal Health Products Summit - Which Way Forward?

Herbal medicinal products are a vital part of the healthcare system in Europe and beyond. Being predominantly sold as non-prescription medicines in pharmacies, they are very popular with patients, physicians, and pharmacists and are therefore an important part of self-medication. Interest in this sector has recently gained momentum, reflecting the ongoing revision of the general pharmaceutical legislation and the recent discussion on nutrition and health claims on foods based on the implementation report of Regulation (EC) No 1924/2006 by the European Parliament 1. Therefore, on 20th February 2024, the Society for Medicinal Plant and Natural Product Research (GA), in collaboration with the German Pharmaceutical Industry Association (BPI) and the German Medicines Manufacturers' Association (BAH, now Pharma Deutschland), hosted an in-person summit in Brussels entitled 'European Herbal Health Products Summit - Which way forward?'. The summit featured a wide range of speakers, including policymakers, regulatory authorities, industry representatives, and academic experts. It was divided into several sessions covering topics such as the future and relevance of herbal medicinal products in the EU, the revision of the EU pharmaceutical legislation, and the resulting impact on herbal medicinal products. Furthermore, the discussions delved into the "Health Claims Regulation" - the European Parliament's implementation report and the related regulatory challenges of herbal medicinal products at an EU level. This consensus paper summarises the current status and provided recommendations to pave the way for future strategies to ascertain the continued use of herbal medicinal products as an important therapeutic option for patients.

Hemp for health: a historical perspective on the marketing of cannabis-based foods in Sweden

Purpose The purpose of this paper is to provide the first comprehensive examination of the early cannabis-based food products industry, using Sweden as a case study. Drawing upon historical newspaper articles and advertisements from the Swedish Historical Newspaper Archive, the authors trace the short-lived development of the industry, from the initial exploitation of fears of tuberculosis in the late 19th century, followed by the “boom” in hempseed extract products and the widening of its claimed effects and, finally, increased skepticism and critiques of such products across the popular press in the early 20th century. Design/methodology/approach A rigorous search of the Swedish Historical Newspaper Archive was conducted to gather newspaper articles and advertisements on cannabis-based foods. The collected resources were scrutinized using critical discourse analysis to tease out key discourses at work, particularly around the concepts of health, nutrition and science. Findings The authors find that central to the marketization of cannabis-based foods was the construction of disease based on scientific and medical discourse, fearmongering to create a strong consumer base and individualization to place responsibility on consumers to take action to protect their family’s health. This demonstrates not only the long historical relationship between science and food marketing but also how brands’ health claims could often be fraudulent or overstated. Originality/value It is important to cast a historical lens on the commercialization of cannabis-based food products because demand for similar types of products has rapidly grown over the past decade. Now, just as before, manufacturers tap into consumers’ insecurities about health, and many of the same questions continue to be mooted about products’ safety. Paying greater attention to the broader and problematic history of commercial cannabis can, thus, serve as a reminder for both consumers and policymakers to think twice about whether hemp really is for health and if the claims it espouses are a mirage rather than a miracle.

Factors influencing perceptions of processed baby foods and feeding practices among Indian mothers: a qualitative investigation

ObjectiveTo explore how professionally qualified, working Indian mothers conceptualize healthy foods in general, perceive processed infant and baby foods available commercially and what feeding practices they actually follow with their children at home.DesignFive focus groups with 8–12 participants were conducted around the participants’ conceptualization of healthy food, their perceptions about commercially available processed baby and infant foods and their actual feeding practices that they routinely follow with their children. Discussion transcripts were analyzed using an inductive coding approach.SettingIndia.ParticipantsFifty-one professionally qualified, working women with at least one child under 5 years of age.ResultsParticipants agreed that fresh food is healthiest. They also had favorable opinions about processed infant and baby foods with regards to healthfulness, hygiene and safety. Healthy foods were largely conceptualized in relation to nutrient claims, ingredients and discernible health outcomes. They use cues, such as health claims, brand, price, package design and others to determine healthfulness of the product. Perception was heavily influenced by these extrinsic cues rather than by participants’ own nutrition knowledge. Despite having the knowledge, most participants admitted to using these foods on account of factors such as their own inability to lactate, social pressure, lack of time and convenience.ConclusionsMost educated and well off people continue to use these products. While they rue the lack of stringent regulatory measures in India, they feel there is an urgent need to address this huge policy gap by way of legislation and regulation.

Updated Risk Assessment of Cannabidiol in Foods Based on Benchmark Dose–Response Modeling

Cannabidiol (CBD), a non-psychotropic main component of the Cannabis plant, has been approved as a drug in the European Union (EU) under the name “Epidyolex”. However, its approval process as a food ingredient under the Novel Food Regulation was paused by the European Food Safety Authority (EFSA) due to a lack of safety data. Nevertheless, there is a growing, unregulated market in which CBD is advertised with various health claims and dosage instructions. Of particular concern is its toxic effect on the liver and possible reproductive toxicity in humans. Studies suitable for calculating the benchmark dose were identified from the available data. Animal studies yielded a benchmark dose lower confidence limit (BMDL) of 43 mg/kg bw/day, which translates into a safe human dose of approximately 15 mg/day. Only the Lowest-Observed-Adverse-Effect Level (LOAEL) of 4.3 mg/kg bw/day could be identified from the human data. This updated risk assessment confirmed a health-based guidance value (HBGV) of 10 mg/day based on human LOAEL. Despite the existing data gaps, preliminary regulation appears advisable because the current form of the gray CBD market is unacceptable from the standpoint of consumer safety and protection.

8469 Endocrinologists Underutilize Virtual Care Services Resulting in Suboptimal Clinical and Financial Outcomes

Abstract Disclosure: D. Terry: Employee; Self; Valendo Health. Less than 150,000 Medicare patients with diabetes (PWD) receive billable telehealth and remote monitoring services, even though over 12 million PWDs are eligible for these services. This is a missed quality opportunity, as studies show that PWDs who receive these services experience reductions in A1C levels and improvements in TIR. It is also a missed financial opportunity for Endocrinologists, who are among the lowest paid specialists in the US. The economics of Endocrinology are important, because inadequate compensation is leading to access constraints when the diabetes population is growing, and care complexity is increasing. We analyzed billed virtual health claims for every Medicare PWD in 2022. The types of services we examined included: Chronic Care Management (CCM &amp; PCM), Continuous Glucose Monitoring (CGM &amp; RPM), Medical Nutrition Therapy (MNT), and Diabetes Self-Management Training (DSMT). When we looked by Endocrinologist by virtual care service type, we found the following levels of service delivery for Endocrinologists at the median levels of utilization:4.8% of eligible PWDs received remote Continuous Glucose Monitoring support.4.2% received virtual Chronic Care Management services.6.2% received virtual Diabetes Self-Management Support.&amp;lt;1% received Medical Nutrition Therapy This is clearly a missed clinical quality opportunity as a study published in JAMA in October 2023, Comprehensive Telehealth Model to Support Diabetes Self-Management, reported the following improvements for PWDs who received virtual care for 6 months:Mean change in A1C levels: Type 1: -0.6%; Type 2: -1.0%Mean TIR Improvement: Type 1: 16%; Type 2: 18% It is also a missed financial opportunity for Endocrinology practices. Each patient with diabetes is potentially eligible for $100 or more of virtual care services per month. We’ve looked at every Endocrinology practice in the US and many are missing out on over a million dollars of annual revenue opportunity. This is important as Endocrinology organizations everywhere, independent and hospital based, are struggling to retain the doctors &amp; staff necessary to provide adequate access to care - leading to months of wait time to see an Endocrinologist. The prevalence of diabetes is growing significantly, while Endocrinologist capacity is shrinking. Value added and billable virtual care services create new opportunities for Endocrinologist to generate the revenue necessary to increase clinical capacity and improve access by creating diverse clinical teams led by Endocrinologists and supported by Diabetes Educators, Dietitians, and others with expertise in diabetes who can care for many more PWDs. Creating virtual care capabilities is also an early step in moving Endocrinology into Value-Based Care arrangements that reward providers for improving care and reducing costs rather than for generating more visits. Presentation: 6/1/2024

Use of rice flour to produce plant-based yogurt alternatives.

Plant-based yogurt alternatives (YAs) are in demand due to the societal prevalence of milk sensitivities and allergies and some consumers abstaining from animal-derived products. Producing rice flour YAs has considerable potential because rice flour is hypoallergenic, more economical compared to plant milks, and there are no commercial rice-based YAs. A new higher protein variety of rice was developed, Frontière, which is sold as both brown and white rice. Therefore, the overall goals of this study were (1) to compare physicochemical properties of YAs from Frontière brown (Frontière brown rice flour [FBRF]) and white (Frontière white rice flour [FWRF]) high-protein rice flours to regular protein level rice flours and (2) to evaluate the sensory quality of Frontière YAs compared to commercial plant-based oat yogurt. Rice flours were fermented with Streptococcus thermophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Lacticaseibacillus rhamnosus (a probiotic) to produce FBRF- and FWRF-YAs. A consumer study was conducted to compare FBRF- and FWRF-YAs to a commercially available oat-based YA. Consumers rated the YAs using 9-point hedonic and just-about-right (JAR) scales. Protein, fat, and ash levels were greater, whereas starch levels and peak viscosities were lower for BRFs than for WRFs. The use of BRF resulted in longer fermentation times but higher bacteria counts for YAs. FWRF-YA was preferred in terms of overall flavor and liking, sweetness, and tartness. Purchase intent (PI) for FWRF-YA increased 2.6 times after providing a health claim. This research showed that rice flour can be used to produce YAs with probiotic counts above the minimum recommended, which provides added health benefits for consumers. PRACTICAL APPLICATION: This research provides a possible new use of Frontière high-protein rice flour to produce plant-based yogurts. This will help the rice industry by adding value, and those who are vegan, allergic to casein, or lactose-intolerant will have another option for a plant-based yogurt. Moreover, the greater levels of probiotic bacteria found in the brown rice flour YAs can potentially provide greater health benefits, making brown rice flour a better choice for making rice-based YAs.