Pubblicazioni

@article{pmid37694915,

title = {Nonchromosomal birth defects and risk of childhood acute leukemia: An assessment in 15 000 leukemia cases and 46 000 controls from the Childhood Cancer and Leukemia International Consortium},

author = {Philip J Lupo and Tiffany M Chambers and Beth A Mueller and Jacqueline Clavel and John D Dockerty and David R Doody and Friederike Erdmann and Sameera Ezzat and Tommaso Filippini and Johnni Hansen and Julia E Heck and Claire Infante-Rivard and Alice Y Kang and Corrado Magnani and Carlotta Malagoli and Erin L Marcotte and Catherine Metayer and Helen D Bailey and Ana M Mora and Evangelia Ntzani and Eleni Th Petridou and Maria S Pombo-de-Oliveira and Wafaa M Rashed and Eve Roman and Joachim Schüz and Catharina Wesseling and Logan G Spector and Michael E Scheurer},

doi = {10.1002/ijc.34720},

issn = {1097-0215},

year  = {2024},

date = {2024-02-01},

journal = {Int J Cancer},

volume = {154},

number = {3},

pages = {434--447},

abstract = {Although recent studies have demonstrated associations between nonchromosomal birth defects and several pediatric cancers, less is known about their role on childhood leukemia susceptibility. Using data from the Childhood Cancer and Leukemia International Consortium, we evaluated associations between nonchromosomal birth defects and childhood leukemia. Pooling consortium data from 18 questionnaire-based and three registry-based case-control studies across 13 countries, we used multivariable logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association between a spectrum of birth defects and leukemia. Our analyses included acute lymphoblastic leukemia (ALL, n = 13 115) and acute myeloid leukemia (AML, n = 2120) cases, along with 46 172 controls. We used the false discovery rate to account for multiple comparisons. In the questionnaire-based studies, the prevalence of birth defects was 5% among cases vs 4% in controls, whereas, in the registry-based studies, the prevalence was 11% among cases vs 7% in controls. In pooled adjusted analyses, there were several notable associations, including (1) digestive system defects and ALL (OR = 2.70, 95% CI: 1.46-4.98); (2) congenital anomalies of the heart and circulatory system and AML (OR = 2.86, 95% CI: 1.81-4.52) and (3) nervous system defects and AML (OR = 4.23, 95% CI: 1.50-11.89). Effect sizes were generally larger in registry-based studies. Overall, our results could point to novel genetic and environmental factors associated with birth defects that could also increase leukemia susceptibility. Additionally, differences between questionnaire- and registry-based studies point to the importance of complementary sources of birth defect phenotype data when exploring these associations.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37980996,

title = {Greenness and neuropsychiatric symptoms in dementia},

author = {Manuela Tondelli and Annalisa Chiari and Giulia Vinceti and Chiara Galli and Simone Salemme and Tommaso Filippini and Chiara Carbone and Claudia Minafra and Claudia De Luca and Riccardo Prandi and Simona Tondelli and Giovanna Zamboni},

doi = {10.1016/j.envres.2023.117652},

issn = {1096-0953},

year  = {2024},

date = {2024-02-01},

journal = {Environ Res},

volume = {242},

pages = {117652},

abstract = {OBJECTIVES: It is acknowledged that living in a green environment may help mental well-being and this may be especially true for vulnerable people. However, the relationship between greenness and neuropsychiatric symptoms in dementia has not been explored yet.nnMETHODS: We collected clinical, neuropsychiatric, and residential data from subjects with dementia living in the province of Modena, Northern Italy. Neuropsychiatric symptoms were measured with the Neuropsychiatry Inventory, a questionnaire administered to the caregiver who assesses the presence and severity of neuropsychiatric symptoms, including delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, sleep disturbances, and appetite/eating changes. Normalized Difference Vegetation Index (NDVI) was used as a proxy of greenness. Regression models were constructed to study the association between greenness and neuropsychiatric features.nnRESULTS: 155 patients with dementia were recruited. We found that greenness is variably associated with the risk of having neuropsychiatric symptoms. The risk of apathy was lower with lower levels of greenness (OR = 0.42, 95% CI 0.19-0.91 for NDVI below the median value). The risk of psychosis was higher with lower levels of greenness but with more imprecise values (OR = 1.77, 95% CI 0.84-3.73 for NDVI below the median value).nnCONCLUSION: Our results suggest a possible association between greenness and neuropsychiatric symptoms in people with dementia. If replicated in larger samples, these findings will pave the road for identifying innovative greening strategies and interventions that can improve mental health in dementia.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38306577,

title = {Win ratio analyses of piperacillin-tazobactam versus meropenem for ceftriaxone non-susceptible Escherichia coli or Klebsiella pneumoniae bloodstream infections: Post-hoc insights from the MERINO trial},

author = {Melissa Hardy and Patrick N A Harris and David L Paterson and Mark D Chatfield and Yin Mo and },

doi = {10.1093/cid/ciae050},

issn = {1537-6591},

year  = {2024},

date = {2024-02-01},

journal = {Clin Infect Dis},

abstract = {BACKGROUND: Clinical trials of treatments for serious infections commonly use the primary endpoint of all-cause mortality. However, many trial participants survive their infection and this endpoint may not truly reflect important benefits and risks of therapy. The win ratio uses a hierarchical composite endpoint that can incorporate and prioritise outcome measures by relative clinical importance.nnMETHODS: The win ratio methodology was applied post-hoc to outcomes observed in the MERINO trial, which compared piperacillin-tazobactam with meropenem. We quantified the win ratio with a primary hierarchical composite endpoint, including all-cause mortality, microbiological relapse and secondary infection. A win ratio of one would correspond to no difference between the two antibiotics, while a ratio less than one favors meropenem. Further analyses were performed to calculate the win odds and to introduce a continuous outcome variable in order to reduce ties.nnRESULTS: With the hierarchy of all-cause mortality, microbiological relapse and secondary infection, the win ratio estimate was 0.40 (95% CI: 0.22, 0.71; p=0.002), favoring meropenem over piperacillin-tazobactam. However, 73.4% of the pairs were tied due to the small proportion of events. The win odds, a modification of the win ratio accounting for ties, was 0.79 (95% CI: 0.68, 0.92). The addition of length of stay to the primary composite, greatly minimised the number of ties (4.6%) with a win ratio estimate of 0.77 (95% CI: 0.60-0.99; p=0.04).nnCONCLUSIONS: The application of the win ratio methodology to the MERINO trial data illustrates its utility and feasibility for use in antimicrobial trials.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38391828,

title = {Investigating Eating Habits of Children Aged between 6 Months and 3 Years in the Provinces of Modena and Reggio Emilia: Is Our Kids' Diet Sustainable for Their and the Planet's Health?},

author = {Lucia Palandri and Laura Rocca and Maria Rosaria Scasserra and Giacomo Pietro Vigezzi and Anna Odone and Lorenzo Iughetti and Laura Lucaccioni and Elena Righi},

doi = {10.3390/healthcare12040453},

issn = {2227-9032},

year  = {2024},

date = {2024-02-01},

journal = {Healthcare (Basel)},

volume = {12},

number = {4},

abstract = {A healthy and balanced diet is crucial for children's well-being and aids in preventing diet-related illnesses. Furthermore, unhealthy dietary habits indirectly impact children's health, as the food industry stands as one of the primary drivers of climate change. Evidence shows the Mediterranean diet is sustainable for both children's and the planet's health. The aim of this cross-sectional study was to evaluate the eating habits of children aged between 6 months and 3 years, in the province of Modena and Reggio Emilia, in Italy, along with their adherence to the guidelines for a healthy diet, and examine the role of pediatricians in promoting knowledge about nutrition and sustainability. In our sample (218 children), most children exceeded the recommended meat and cheese intake, while consuming insufficient amounts of vegetables, fruit, and legumes. Vegetable and fruit consumption declined with the increase in age category while eating sweets, soft drinks, and processed food increased. Incorporating school meals' data into this analysis, we observed a modification in dietary compliance, characterized by an increase in meat and cheese consumption, alongside improvements in the intake of vegetables, fruits, fish, eggs, and legumes. This study suggests that supporting an integrated approach that combines social and educational initiatives is crucial. Future research should prioritize fostering sustainable eating habits within communities to facilitate dietary habits' transformation and encourage healthier lifestyles.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38356610,

title = {Conditioning factors in the spreading of Covid-19 - Does geography matter?},

author = {Vittoria Vandelli and Lucia Palandri and Paola Coratza and Cristiana Rizzi and Alessandro Ghinoi and Elena Righi and Mauro Soldati},

doi = {10.1016/j.heliyon.2024.e25810},

issn = {2405-8440},

year  = {2024},

date = {2024-02-01},

journal = {Heliyon},

volume = {10},

number = {3},

pages = {e25810},

abstract = {There is evidence in literature that the spread of COVID-19 can be influenced by various geographic factors, including territorial features, climate, population density, socioeconomic conditions, and mobility. The objective of the paper is to provide an updated literature review on geographical studies analysing the factors which influenced COVID-19 spreading. This literature review took into account not only the geographical aspects but also the COVID-19-related outcomes (infections and deaths) allowing to discern the potential influencing role of the geographic factors per type of outcome. A total of 112 scientific articles were selected, reviewed and categorized according to subject area, aim, country/region of study, considered geographic and COVID-19 variables, spatial and temporal units of analysis, methodologies, and main findings. Our literature review showed that territorial features may have played a role in determining the uneven geography of COVID-19; for instance, a certain agreement was found regarding the direct relationship between urbanization degree and COVID-19 infections. For what concerns climatic factors, temperature was the variable that correlated the best with COVID-19 infections. Together with climatic factors, socio-demographic ones were extensively taken into account. Most of the analysed studies agreed that population density and human mobility had a significant and direct relationship with COVID-19 infections and deaths. The analysis of the different approaches used to investigate the role of geographic factors in the spreading of the COVID-19 pandemic revealed that the significance/representativeness of the outputs is influenced by the scale considered due to the great spatial variability of geographic aspects. In fact, a more robust and significant association between geographic factors and COVID-19 was found by studies conducted at subnational or local scale rather than at country scale.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38029816,

title = {Does fluoride exposure affect thyroid function? A systematic review and dose-response meta-analysis},

author = {Inga Iamandii and Lisa De Pasquale and Maria Edvige Giannone and Federica Veneri and Luigi Generali and Ugo Consolo and Linda S Birnbaum and Jacqueline Castenmiller and Thorhallur I Halldorsson and Tommaso Filippini and Marco Vinceti},

doi = {10.1016/j.envres.2023.117759},

issn = {1096-0953},

year  = {2024},

date = {2024-02-01},

journal = {Environ Res},

volume = {242},

pages = {117759},

abstract = {INTRODUCTION: Fluoride exposure may have various adverse health effects, including affecting thyroid function and disease risk, but the pattern of such relation is still uncertain.nnMETHODS: We systematically searched human studies assessing the relation between fluoride exposure and thyroid function and disease. We compared the highest versus the lowest fluoride category across these studies, and we performed a one-stage dose-response meta-analysis for aggregated data to explore the shape of the association.nnRESULTS: Most retrieved studies (27 of which with a cross-sectional design) were conducted in Asia and in children, assessing fluoride exposure through its concentrations in drinking water, urine, serum, or dietary intake. Twenty-four studies reported data on thyroid function by measuring thyroid-related hormones in blood (mainly thyroid-stimulating-hormone - TSH), 9 reported data on thyroid disease, and 4 on thyroid volume. By comparing the highest versus the lowest fluoride categories, overall mean TSH difference was 1.05 μIU/mL. Dose-response curve showed no change in TSH concentrations in the lowest water fluoride exposure range, while the hormone levels started to linearly increase around 2.5 mg/L, also dependending on the risk of bias of the included studies. The association between biomarkers of fluoride exposure and TSH was also positive, with little evidence of a threshold. Evidence for an association between fluoride exposure and blood concentrations of thyroid hormones was less evident, though there was an indication of inverse association with triiodothyronine. For thyroid disease, the few available studies suggested a positive association with goiter and with hypothyroidism in both children and adults.nnCONCLUSIONS: Overall, exposure to high-fluoride drinking water appears to non-linearly affect thyroid function and increase TSH release in children, starting above a threshold of exposure, and to increase the risk of some thyroid diseases.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38303639,

title = {Adverse human health effects of climate change: an update},

author = {Tommaso Filippini and Stefania Paduano and Federica Veneri and Giulia Barbolini and Gianluca Fiore and Marco Vinceti},

doi = {10.7416/ai.2024.2595},

issn = {1120-9135},

year  = {2024},

date = {2024-02-01},

journal = {Ann Ig},

abstract = {BACKGROUND: The world is currently facing a process of climate change, which may adversely impact human health in many different ways. The safety of food, water and urban environments is endangered by the consequences of climate change. Sea level and temperature rise, along with more frequent and longer heat waves, represent only a few of the effects of climate change. The increased risk of extreme climate events (e.g., cyclones, droughts and floods) is another serious public health issue. These adverse effects are enhanced in areas and countries not having the capacity to effectively deal with climate change.nnSTUDY DESIGN: We primarily aimed at summarizing the impacts of climate change on public health. A further aim was to identify the most concerning consequences of this phenomenon and the vulnerability factors that amplify the negative effects of climate change.nnMETHODS: PubMed and other literature databases were used as literature sources for this narrative review based on the search terms 'climate change' and 'diseases categories' up to January 2024, in order to assess the most recent and relevant scientific evidence about the relation between climate change and public health, identify knowledge gaps and priorities for future research. We also screened the websites of major agencies devoted to human health protection and environmental health.nnRESULTS AND CONCLUSIONS: Climate change appears to induce a broad spectrum of generally adverse effects on public health. It may increase the risk of infectious diseases, psychiatric disorders, cancer and other diseases. Currently, we are not effectively counteracting this phenomenon, since pollutant and greenhouse gas emissions have been increasing alongside temperatures. A host of measures are required in order to prevent and fight climate change and related health effects. These include the adoption of a holistic approach and the collaboration of different kinds of expertise in order to design more effective strategies. Special attention should be paid to those who live in disadvantaged countries, and those who are more vulnerable to the adverse health consequences of climate change.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38322231,

title = {Extension of use of isomalto-oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Miguel Prieto Maradona and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Océane Albert and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2024.8543},

issn = {1831-4732},

year  = {2024},

date = {2024-02-01},

journal = {EFSA J},

volume = {22},

number = {2},

pages = {e8543},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of isomalto-oligosaccharide (IMO) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of glucose oligomers with degrees of polymerisation of 3-9, along with various amounts of mono- and disaccharides. The NF comes in both syrup and powder form. The applicant intends to extend the current uses of the NF as an ingredient in several foods, and use the NF in food supplements aimed at the general population older than 10 years of age. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. Along with literature data, the applicant carried out a tolerability study in adult volunteers with the NF at doses up to 120 g/day. The Panel concludes that this study provides reassurance that the NF is tolerable at doses of 120 g/day. Conservative intake estimates resulting from the use of the NF as an ingredient according to the currently authorised uses and new proposed uses result in a highest intake estimate in adolescents of 112 g/day at the 95th percentile, and reach 142 g/day in adolescents when the use as a food supplement is included. The Panel notes this amount is higher than the dose of 120 g/day for which tolerability has been demonstrated. However, considering the source, compositional characterisation, production process and nature of the NF, as well as the available nutritional and toxicological data on the NF, the Panel considers that the NF does not present safety concerns under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37312419,

title = {Toxicological effects of selenium nanoparticles in laboratory animals: A review},

author = {Yuliya V Ryabova and Marina P Sutunkova and Ilzira A Minigalieva and Lada V Shabardina and Tommaso Filippini and Aristides Tsatsakis},

doi = {10.1002/jat.4499},

issn = {1099-1263},

year  = {2024},

date = {2024-01-01},

journal = {J Appl Toxicol},

volume = {44},

number = {1},

pages = {4--16},

abstract = {This paper provides a comprehensive summary of the main toxicological studies conducted on selenium nanoparticles (NPs) using laboratory animals, up until February 28, 2023. A literature search revealed 17 articles describing experimental studies conducted on warm-blooded animals. Despite some uncertainties, in vivo studies have demonstrated that selenium NPs have an adverse effect on laboratory animals, as evidenced by several indicators of general toxic action. These effects include reductions of body mass, changes in hepatotoxicity indices (increased enzyme activity and accumulation of selenium in the liver), and the possibility of impairment of fatty acid, protein, lipid, and carbohydrate metabolisms. However, no specific toxic action attributable solely to selenium has been identified. The LOAEL and NOAEL values are contradictory. The NOAEL was 0.22 mg/kg body weight per day for males and 0.33 mg/kg body weight per day for females, while the LOAEL was assumed to be a dose of 0.05 mg/kg of nanoselenium. This LOAEL value is much higher for rats than for humans. The relationship between the adverse effects of selenium NPs and exposure dose is controversial and presents a wide typological diversity. Further research is needed to clarify the absorption, metabolism, and long-term toxicity of selenium NPs, which is critical to improving the risk assessment of these compounds.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38236001,

title = {Fluoride and caries prevention: a scoping review of public health policies},

author = {Federica Veneri and Silvio Roberto Vinceti and Tommaso Filippini},

doi = {10.7416/ai.2024.2593},

issn = {1120-9135},

year  = {2024},

date = {2024-01-01},

journal = {Ann Ig},

abstract = {BACKGROUND: Dental caries is the most common infectious disease, affecting approximately 60 to 90% of the world population, especially young children, and disadvantaged communities. Due to the extremely high prevalence and the significant negative impact on general health, well-being, and quality of life it is considered a global public health problem. Despite the improvement of policies to promote oral health care in the past decades, dental caries is still a healthcare challenge, characterized by increasing disparities among different social groups between and within countries. Fluoride-based prevention of dental caries is a cost-effective approach, that has been implemented since 1940's. It includes systemic and topical administrations, through community-based or individual programs. Preventive interventions should be tailored to individual and community caries risk assessment and estimate of cumulative fluoride intake, in order to maximize the preventive effect and avoid the risk of potential adverse effects associated with excessive fluoride exposure. Regulation of public health policies plays a major role in this context.nnSTUDY DESIGN: Scoping review.nnMETHODS: The aim of this scoping review was to report an overview of current guidelines regarding fluoride-based preventive strategies for dental caries and relevant policies on the matter, as well as to address current issues related to public health aspects of dental caries prevention. We searched for the relevant literature on the matter, focusing on policy documents, such as recommendations, position papers and guidelines, issued from the major scientific and regulatory institutions involved in oral health promotion and on publications concerning relevant aspects of public health law.nnRESULTS: Prevention of dental caries through fluoride can rely on topical fluorides for home-use (toothpastes and mouthrinses), professionally applied topical fluorides (gels, varnishes, silver diamine fluoride, fluoride-releasing restorative materials and sealants), fluoride supplements (tablets and drops), and community-based strategies (community water fluoridation, fluoridated salt and milk). Current relevant guidelines for all these preventive aids are outlined in the paper. A significantly greater preventive effect of topical fluorides has been widely established in the recent past, as compared to systemic effects. Furthermore, increasing concerns have emerged on potential adverse effects on general health associated with early and excessive systemic exposure to fluoride, especially for children, supported by recent meta-analyses. Also, community water fluoridation has raised significant aspects of relevance for health law and policies. In a public health perspective, healthcare policymakers should tackle social iniquities by promoting information and oral health literacy, through community and school-based programs, ensuring access to early dental visits and basic dental care and improving availability and affordability of fluoride topical products.nnCONCLUSIONS: Fluoride-based prevention can provide a simple and cost-effective approach to reduce the incidence of dental caries and the associated social burden. Among fluoride-based preventive strategies, systemic community-based administration of fluoride should be considered with great caution, due to the unfavorable risk-benefit ratio currently established. Topical fluoridated products are generally preferred, given the optimal risk-benefit ratio. Further efforts must be made to identify and tackle the barriers to dental caries prevention and related social iniquities from a public health perspective. Policies and laws on oral health should promote access to caries prevention with targeted comprehensive strategies.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38265641,

title = {Water fluoridation between public health and public law: an assessment of regulations across countries and their preventive medicine implications},

author = {Silvio Roberto Vinceti and Federica Veneri and Tommaso Filippini},

doi = {10.7416/ai.2024.2594},

issn = {1120-9135},

year  = {2024},

date = {2024-01-01},

journal = {Ann Ig},

abstract = {BACKGROUND: Among health professionals and health policymakers concern is growing as to the difficulty of balancing the prevention of dental caries through cost-effective interventions and the need to limit unnecessary exposure of the population, and especially children, to environmental chemicals. In this respect, the use of water fluoridation to prevent tooth decay epitomizes the dilemma by raising questions relevant to both public health and public law, ranging from the balance of public health and medical selfdetermination, the division of powers between local or national authorities over water fluoridation, and the need to avoid the adverse effects of socioeconomic inequalities as well as both under- and over-exposure.nnSTUDY DESIGN: We carried out a narrative review by searching the relevant literature about the laws and rules related to drinking water fluoridation at the community level in the US, UK, and Europe, in order to discuss how the issue is handled from both a public health and public law perspective.nnMETHODS: Sources of data for this review were the biomedical and legal literature retrieved by searching online databases, and websites of public health and legal institutions.nnRESULTS AND CONCLUSIONS: We found that water fluoridation is still largely adopted throughout the US, while in the UK and particularly in the European Union only a minor part of the population is subject to it. In addition, the recommended and maximum allowed amounts of fluoride in drinking water are being adapted to the public health recommendations and the new regulations, within an evolving evaluation of the epidemiologic evidence and the risk assessment currently in progress by two major regulatory agencies, the US National Toxicology Program - NTP and the European Food Safety Authority - EFSA. Under a comparative public law perspective, the three investigated legislations are facing a reassessment of their policies and regulations, to allow for effective and safe public health measures in the field of water fluoridation and more generally for a preferred use of topical fluoride for caries.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38337469,

title = {Short-Term Effects of 3D-Printed Occlusal Splints and Conventional Splints on Sleep Bruxism Activity: EMG-ECG Night Recordings of a Sample of Young Adults},

author = {Andrea Bargellini and Elena Mannari and Giovanni Cugliari and Andrea Deregibus and Tommaso Castroflorio and Leila Es Sebar and Gianpaolo Serino and Andrea Roggia and Nicola Scotti},

doi = {10.3390/jcm13030776},

issn = {2077-0383},

year  = {2024},

date = {2024-01-01},

journal = {J Clin Med},

volume = {13},

number = {3},

abstract = {(1) : This study aims to compare the effects of 3D-printed splints and conventional manufactured splints on sleep bruxism (SB) EMG activity. (2) : Twenty-six patients (19 M, 7 F, 25.8 ± 2.6 years) were randomly allocated to a study group (3D splints) and a control group (conventional manufactured splints) and followed for a period of three months with night EMG-ECG recordings. Samples of the involved materials were analyzed for nanoindentation. The outcomes of interest considered were the overall SB index, the total amount of surface masseter muscle activity (sMMA), and general and SB-related phasic and tonic contractions. A statistical evaluation was performed with a confidence interval (CI) between 2.5% and 97.5%. (3) : Differences between groups with OAs were observed for general tonic contraction ( = 0.0009), while differences between recording times were observed for general phasic contractions ( = 0.002) and general tonic contractions ( = 0.00001). Differences between recording times were observed for the total amount of sMMA ( = 0.01), for general phasic contractions ( = 0.0001), and for general tonic contractions ( = 0.000009) during night recordings without OAs. (4) : Three-dimensional splints seem to have a higher impact on SB-related electromyographic activity but not on the overall sleep bruxism index. The more regular surfaces offered by 3D splints could be related to phasic contraction stabilization.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38257958,

title = {Gut Microbiome Disruption Following SARS-CoV-2: A Review},

author = {Elda Righi and Ilaria Dalla Vecchia and Nina Auerbach and Matteo Morra and Anna Górska and Concetta Sciammarella and Lorenza Lambertenghi and Elisa Gentilotti and Massimo Mirandola and Evelina Tacconelli and Assunta Sartor},

doi = {10.3390/microorganisms12010131},

issn = {2076-2607},

year  = {2024},

date = {2024-01-01},

journal = {Microorganisms},

volume = {12},

number = {1},

abstract = {COVID-19 has been associated with having a negative impact on patients' gut microbiome during both active disease and in the post-acute phase. In acute COVID-19, rapid alteration of the gut microbiome composition was observed, showing on one side a reduction in beneficial symbionts (e.g., , ) and on the other side an increase in opportunistic pathogens such as  and . Alpha diversity tends to decrease, especially initially with symptom onset and hospital admission. Although clinical recovery appears to align with improved gut homeostasis, this process could take several weeks, even in mild infections. Moreover, patients with COVID-19 post-acute syndrome showed changes in gut microbiome composition, with specific signatures associated with decreased respiratory function up to 12 months following acute disease. Potential treatments, especially probiotic-based therapy, are under investigation. Open questions remain on the possibility to use gut microbiome data to predict disease progression and on potential confounders that may impair result interpretation (e.g., concomitant therapies in the acute phase; reinfection, vaccines, and occurrence of novel conditions or diseases in the post-acute syndrome). Understanding the relationships between gut microbiome dynamics and disease progression may contribute to better understanding post-COVID syndrome pathogenesis or inform personalized treatment that can affect specific targets or microbiome markers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38267801,

title = {Clinical presentation and antimicrobial resistance of invasive Escherichia coli disease in hospitalized older adults: a prospective multinational observational study},

author = {Joachim Doua and Jesús Rodríguez-Baño and Rachel Froget and Padma Puranam and Oscar Go and Jeroen Geurtsen and Sanne van Rooij and Tuba Vilken and Inage Minoru and Izumi Yasumori and Bart Spiessens and Evelina Tacconelli and Lena M Biehl and Joshua T Thaden and Michal Sarnecki and Herman Goossens and Jan Poolman and Marc Bonten and Miquel Ekkelenkamp and },

doi = {10.1007/s15010-023-02163-z},

issn = {1439-0973},

year  = {2024},

date = {2024-01-01},

journal = {Infection},

abstract = {BACKGROUND: Clinical data characterizing invasive Escherichia coli disease (IED) are limited. We assessed the clinical presentation of IED and antimicrobial resistance (AMR) patterns of causative E. coli isolates in older adults.nnMETHODS: EXPECT-2 (NCT04117113) was a prospective, observational, multinational, hospital-based study conducted in patients with IED aged ≥ 60 years. IED was determined by the microbiological confirmation of E. coli from blood; or by the microbiological confirmation of E. coli from urine or an otherwise sterile body site in the presence of requisite criteria of systemic inflammatory response syndrome (SIRS), Sequential Organ Failure Assessment (SOFA), or quick SOFA (qSOFA). The primary outcomes were the clinical presentation of IED and AMR rates of E. coli isolates to clinically relevant antibiotics. Complications and in-hospital mortality were assessed through 28 days following IED diagnosis.nnRESULTS: Of 240 enrolled patients, 80.4% had bacteremic and 19.6% had non-bacteremic IED. One-half of infections (50.4%) were community-acquired. The most common source of infection was the urinary tract (62.9%). Of 240 patients, 65.8% fulfilled ≥ 2 SIRS criteria, and 60.4% had a total SOFA score of ≥ 2. Investigator-diagnosed sepsis and septic shock were reported in 72.1% and 10.0% of patients, respectively. The most common complication was kidney dysfunction (12.9%). The overall in-hospital mortality was 4.6%. Of 299 E. coli isolates tested, the resistance rates were: 30.4% for trimethoprim-sulfamethoxazole, 24.1% for ciprofloxacin, 22.1% for levofloxacin, 16.4% for ceftriaxone, 5.7% for cefepime, and 4.3% for ceftazidime.nnCONCLUSIONS: The clinical profile of identified IED cases was characterized by high rates of sepsis. IED was associated with high rates of AMR to clinically relevant antibiotics. The identification of IED can be optimized by using a combination of clinical criteria (SIRS, SOFA, or qSOFA) and culture results.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38236000b,

title = {The key role of public health in renovating Italian biomedical doctoral programs},

author = {Lucia Palandri and Teresa Urbano and Carla Pezzuoli and Francesca Miselli and Riccardo Caraffi and Tommaso Filippini and Annalisa Bargellini and Elena Righi and Davide Mazzi and Giacomo Pietro Vigezzi and Anna Odone and Sandra Marmiroli and Giuseppe Boriani and Marco Vinceti},

doi = {10.7416/ai.2024.2592},

issn = {1120-9135},

year  = {2024},

date = {2024-01-01},

journal = {Ann Ig},

abstract = {BACKGROUND: A key renovation of doctoral programs is currently ongoing in Italy. Public health and its competencies may play a pivotal role in high-level training to scientific research, including interdisciplinary and methodological abilities.nnMETHODS: As a case study, we used the ongoing renovation of the Clinical and Experimental Medicine doctoral program at the University of Modena and Reggio Emilia. We focused on how the program is designed to meet national requirements as well as students' needs, thus improving educational standards for scientific research in the biomedical field, and on the specific contribution of public health and epidemiology in such an effort.nnRESULTS: The renovation process of doctoral programs in Italy, with specific reference to the biomedical field, focuses on epidemiologic-statistical methodology, ethics, language and communication skills, and open science from an interdisciplinary and international perspective. In the specific context of the doctoral program assessed in the study and from a broader perspective, public health appears to play a key role, taking advantage of most recent methodological advancements, and contributing to the renovation of the learning process and its systematic quality monitoring.nnCONCLUSIONS: From a comparative assessment of this case study and Italian legislation, the key role of public health has emerged in the renovation process of doctoral programs in the biomedical field.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38043604,

title = {Dairy Intake and Risk of Cognitive Decline and Dementia: A Systematic Review and Dose-Response Meta-Analysis of Prospective Studies},

author = {Fanny Villoz and Tommaso Filippini and Natalia Ortega and Doris Kopp-Heim and Trudy Voortman and Manuel R Blum and Cinzia Del Giovane and Marco Vinceti and Nicolas Rodondi and Patricia O Chocano-Bedoya},

doi = {10.1016/j.advnut.2023.100160},

issn = {2156-5376},

year  = {2024},

date = {2024-01-01},

journal = {Adv Nutr},

volume = {15},

number = {1},

pages = {100160},

abstract = {Dairy intake may influence cognition through several molecular pathways. However, epidemiologic studies yield inconsistent results, and no dose-response meta-analysis has been conducted yet. Therefore, we performed a systematic review with a dose-response meta-analysis about the association between dairy intake and cognitive decline or incidence of dementia. We investigated prospective studies with a follow-up ≥6 mo on cognitive decline or dementia incidence in adults without known chronic conditions through a systematic search of Embase, Medline, Cochrane Library, Web of Science, and Google Scholar from inception to 11 July 2023. We evaluated the dose-response association using a random-effects model. We identified 15 eligible cohort studies with >300,000 participants and a median follow-up of 11.4 y. We observed a negative nonlinear association between cognitive decline/dementia incidence and dairy intake as assessed through the quantity of consumption, with the nadir at ∼150 g/d (risk ratio: 0.88; 95% confidence interval: 0.78, 0.99). Conversely, we found an almost linear negative association when we considered the frequency of consumption (risk ratio for linear trend: 0.84; 95% confidence interval: 0.77, 0.92 for 1 time/d increase of dairy products). Stratified analysis by dairy products showed different shapes of the association with linear inverse relationship for milk intake, whereas possibly nonlinear for cheese. The inverse association was limited to Asian populations characterized by generally lower intake of dairy products, compared with the null association reported by European studies. In conclusion, our study suggests a nonlinear inverse association between dairy intake and cognitive decline or dementia, also depending on dairy types and population characteristics, although the heterogeneity was still high in overall and several subgroup analyses. Additional studies should be performed on this topic, including a wider range of intake and types of dairy products, to confirm a potential preventing role of dairy intake on cognitive decline and identify ideal intake doses. This review was registered at PROSPERO as CRD42020192395.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38236000,

title = {The key role of public health in renovating Italian biomedical doctoral programs},

author = {Lucia Palandri and Teresa Urbano and Carla Pezzuoli and Francesca Miselli and Riccardo Caraffi and Tommaso Filippini and Annalisa Bargellini and Elena Righi and Davide Mazzi and Giacomo Pietro Vigezzi and Anna Odone and Sandra Marmiroli and Giuseppe Boriani and Marco Vinceti},

doi = {10.7416/ai.2024.2592},

issn = {1120-9135},

year  = {2024},

date = {2024-01-01},

journal = {Ann Ig},

abstract = {BACKGROUND: A key renovation of doctoral programs is currently ongoing in Italy. Public health and its competencies may play a pivotal role in high-level training to scientific research, including interdisciplinary and methodological abilities.nnMETHODS: As a case study, we used the ongoing renovation of the Clinical and Experimental Medicine doctoral program at the University of Modena and Reggio Emilia. We focused on how the program is designed to meet national requirements as well as students' needs, thus improving educational standards for scientific research in the biomedical field, and on the specific contribution of public health and epidemiology in such an effort.nnRESULTS: The renovation process of doctoral programs in Italy, with specific reference to the biomedical field, focuses on epidemiologic-statistical methodology, ethics, language and communication skills, and open science from an interdisciplinary and international perspective. In the specific context of the doctoral program assessed in the study and from a broader perspective, public health appears to play a key role, taking advantage of most recent methodological advancements, and contributing to the renovation of the learning process and its systematic quality monitoring.nnCONCLUSIONS: From a comparative assessment of this case study and Italian legislation, the key role of public health has emerged in the renovation process of doctoral programs in the biomedical field.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38260771,

title = {Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Miguel Prieto Maradona and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Lucien Ferreira da Costa and Océane Albert and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2024.8491},

issn = {1831-4732},

year  = {2024},

date = {2024-01-01},

journal = {EFSA J},

volume = {22},

number = {1},

pages = {e8491},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on isomaltulose syrup (dried) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of a mixture of mono- and disaccharides in powder form, mainly composed of isomaltulose (≥ 75%) and trehalulose (< 13%). The applicant intends to use the NF as a replacement for sucrose already on the market. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. No absorption, distribution, metabolism and excretion (ADME) or toxicological data were provided for the NF. Instead, the safety of the NF was assessed based on literature data available on isomaltulose and mixtures of isomaltulose and trehalulose. In addition, considering the nature, compositional characterisation and production process of the NF, the Panel considered that such data were sufficient to conclude that the NF is as safe as sucrose.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38269034,

title = {Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuhäuser-Berthold and Carmen Peláez and Morten Poulsen and Miguel Prieto Maradona and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Maura Magani and Alejandra Muñoz and Annamaria Rossi and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2024.8492},

issn = {1831-4732},

year  = {2024},

date = {2024-01-01},

journal = {EFSA J},

volume = {22},

number = {1},

pages = {e8492},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on HelixComplex Snail Mucus (HSM) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of snail mucus collected from  and is proposed to be used by adults as a food supplement. The data provided by the applicant about the composition and stability of the NF together with the report of the subchronic toxicity study were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the certificates of analysis and of the data on the subchronic toxicity provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38295933,

title = {Cadmium exposure and cardiovascular disease risk: A systematic review and dose-response meta-analysis},

author = {Pietro Verzelloni and Teresa Urbano and Lauren A Wise and Marco Vinceti and Tommaso Filippini},

doi = {10.1016/j.envpol.2024.123462},

issn = {1873-6424},

year  = {2024},

date = {2024-01-01},

journal = {Environ Pollut},

volume = {345},

pages = {123462},

abstract = {Exposure to toxic metals is a global public health threat. Among other adverse effects, exposure to the heavy metal cadmium has been associated with greater risk of cardiovascular disease (CVD). Nonetheless, the shape of the association between cadmium exposure and CVD risk is not clear. This systematic review summarizes data on the association between cadmium exposure and risk of CVD using a dose-response approach. We carried out a literature search in PubMed, Web of Science, and Embase from inception to December 30, 2023. Inclusion criteria were: studies on adult populations, assessment of cadmium exposure, risk of overall CVD and main CVD subgroups as endpoints, and observational study design (cohort, cross-sectional, or case-control). We retrieved 26 eligible studies published during 2005-2023, measuring cadmium exposure mainly in urine and whole blood. In a dose-response meta-analysis using the one-stage method within a random-effects model, we observed a positive association between cadmium exposure and risk of overall CVD. When using whole blood cadmium as a biomarker, the association with overall CVD risk was linear, yielding a risk ratio (RR) of 2.58 (95 % confidence interval-CI 1.78-3.74) at 1 μg/L. When using urinary cadmium as a biomarker, the association was linear until 0.5 μg/g creatinine (RR = 2.79, 95 % CI 1.26-6.16), after which risk plateaued. We found similar patterns of association of cadmium exposure with overall CVD mortality and risks of heart failure, coronary heart disease, and overall stroke, whereas for ischemic stroke there was a positive association with mortality only. Overall, our results suggest that cadmium exposure, whether measured in urine or whole blood, is associated with increased CVD risk, further highlighting the importance of reducing environmental pollution from this heavy metal.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38131799,

title = {Factors Associated with SARS-CoV-2 Infection Evaluated by Antibody Response in a Sample of Workers from the Emilia-Romagna Region, Northern Italy},

author = {Stefania Paduano and Michele Granata and Sara Turchi and Alberto Modenese and Pasquale Galante and Alessandro Poggi and Isabella Marchesi and Giuseppina Frezza and Giulia Dervishaj and Roberto Vivoli and Sara Verri and Simona Marchetti and Fabriziomaria Gobba and Annalisa Bargellini},

doi = {10.3390/antib12040077},

issn = {2073-4468},

year  = {2023},

date = {2023-12-01},

journal = {Antibodies (Basel)},

volume = {12},

number = {4},

abstract = {Factors associated with SARS-CoV-2 infection risk are still debated. This case-control study aims to investigate the possible relationship between SARS-CoV-2 infection, evaluated through antibody response, and the main sociodemographic, occupational, clinical-anamnestic, and biochemical factors in a population of Modena province (Northern Italy), mainly workers. Both workers who voluntarily joined the screening campaign proposed by companies and self-referred individuals who underwent serological testing were enrolled. Subjects with antibody positivity were recruited as cases ( = 166) and subjects tested negative ( = 239) as controls. A questionnaire on sociodemographic, occupational, and clinical data was administered through telephone interviews. Serum zinc/iron/copper/chromium/nickel, vitamins D/B12, folates, triglycerides, and LDL/HDL/total cholesterol were measured. Cases lived more often in urban areas (61.8% vs. 57%). Cases and controls did not differ significantly by working macrocategories, but the percentage of workers in the ceramic sector was higher among cases. Low adherence to preventive measures in the workplace was more frequent among seropositives. Folate concentration was significantly lower among cases. Therefore, adequate folate levels, living in rural areas, and good adherence to preventive strategies seem protective against infection. Workers in the ceramic sector seem to be at greater risk; specific factors involved are not defined, but preventive interventions are needed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38054684,

title = {Nursing students' evaluation of clinical learning environment and supervision models before and during the COVID-19 pandemic: a comparative study},

author = {Paola Ferri and Serena Stifani and Elena Morotti and Sara Alberti and Valeria Vannini and Rosaria Di Lorenzo and Sergio Rovesti and Alvisa Palese},

doi = {10.23750/abm.v94i6.14750},

issn = {2531-6745},

year  = {2023},

date = {2023-12-01},

journal = {Acta Biomed},

volume = {94},

number = {6},

pages = {e2023256},

abstract = {BACKGROUND AND AIM: The COVID-19 pandemic has required a rapid reorganization of clinical training and supervision models for nursing education. The aim of this study was to compare students' levels of perception of the quality of the Clinical Learning Environment (CLE) using two different clinical supervision models.nnMETHODS: A comparative design was implemented. A convenience sample of second and third-year undergraduate nursing students (n=127) in clinical training in the 2018/2019 Academic Year (AY) received the usual nursing staff supervision model, while during the COVID-19 pandemic in the following year, they (n=69) received an individualized supervision model. Data were collected using three instruments: the Clinical Learning Environmental Quality Evaluation Index (CLEQI); the Clinical Learning Environment, Supervision and Nurse Teacher Scale (CLES+T); and a socio-demographic tool.nnRESULTS: The mean total scores of both scales had increased in the second survey (CLEQI: M=57.88±11.8 vs. M=60.88±9.3, p=0.035; CLES+T: M=148.4±23.3 vs. M=154.5±21.9, p=0.037). The nursing students reported high levels of CLE quality with both supervision models, even though the individualized supervision model was rated significantly higher by the students than the staff supervision model.nnCONCLUSIONS: Students supported by a personal supervisor during clinical training had a more positive experience and rated the quality of the tutorial strategies, learning opportunities, safety and nursing care, leadership style of the ward manager and overall CLE more highly.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37079345,

title = {The effects of primary care monitoring strategies on COVID-19 related hospitalisation and mortality: a retrospective electronic medical records review in a northern Italian province, the MAGMA study},

author = {Alice Serafini and Lucia Palandri and Peter Konstantin Kurotschka and Chiara Giansante and Maria Rita Sabattini and Martina Alfina Lavenia and Marina Scarpa and Davide Fornaciari and Matteo Morandi and Francesco Bellelli and Maria Stella Padula and Elena Righi and Giulia Ugolini and Silvia Riccomi and  and },

doi = {10.1080/13814788.2023.2186395},

issn = {1751-1402},

year  = {2023},

date = {2023-12-01},

journal = {Eur J Gen Pract},

volume = {29},

number = {2},

pages = {2186395},

abstract = {BACKGROUND: Most symptomatic SARS-CoV-2 infections produce mild to moderate symptoms. Although most patients are managed in the outpatient setting, little is known about the effect of general practitioners' (GP) management strategies on the outcomes of COVID-19 outpatients in Italy.nnOBJECTIVES: Describe the management of Italian GPs of SARS-CoV-2 infected adult patients and explore whether GP active care and monitoring are associated with reducing hospitalisation and death.nnMETHODS: Retrospective observational study of SARS-CoV-2 infected adult outpatients managed by GPs in Modena (Italy) from March 2020 to April 2021. Information on management and monitoring strategies, patients' socio-demographic characteristics, comorbidities, and outcomes (hospitalisation and death due to COVID-19) were retrieved through an electronic medical record review and analysed descriptively and through multiple logistic regression.nnRESULTS: Out of the 5340 patients from 46 GPs included in the study, 3014 (56%) received remote monitoring, and 840 (16%) had at least one home visit. More than 85% of severe or critical patients were actively monitored (73% daily) and 52% were visited at home. Changes over time in patients' therapeutic management were observed in concordance with the guidelines' release. Active daily remote monitoring and home visits were strongly associated with reduced hospitalisation rate (OR 0.52, 95% CI 0.33-0.80 and OR 0.50, 95% CI 0.33-0.78 respectively).nnCONCLUSION: GPs effectively managed an increasing number of outpatients during the first waves of the pandemic. Active monitoring and home visits were associated with reduced hospitalisation in COVID-19 outpatients.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38031856,

title = {[Home management of Covid-19 pneumonia in the early phases of the pandemic: analysis of real-life data of General Practitioners in the Province of Modena from the MAGMA study.]},

author = {Giulia Ugolini and Alice Serafini and Lucia Palandri and Chiara Giansante and Davide Fornaciari and Marco Marietta and Maria Stella Padula and Elisa Stefani and Elena Righi and Silvia Riccomi},

doi = {10.1701/4142.41392},

issn = {2038-1840},

year  = {2023},

date = {2023-12-01},

journal = {Recenti Prog Med},

volume = {114},

number = {12},

pages = {740--743},

abstract = {Primary care management of Covid-19 pneumonia in the Province of Modena in the early phases of the pandemic: data integration from MAGMA study. Retrospective study on patients affected of Covid-19 and followed by General Practitioner from March 2020 to April 2021. 5340 patients were studied, 27% of them developed pneumoniae. Among these, most of them were managed entirely at home with an elevated intensity of care. Daily remote monitoring and home visits, together with a personalized pharmacological treatment, especially for the most severe forms, appeared to be the most effective interventions in reducing hospitalizations.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37668704,

title = {Predictors for progression in amyotrophic lateral sclerosis associated to SOD1 mutation: insight from two population-based registries},

author = {Ilaria Martinelli and Andrea Ghezzi and Elisabetta Zucchi and Giulia Gianferrari and Laura Ferri and Cristina Moglia and Umberto Manera and Luca Solero and Rosario Vasta and Antonio Canosa and Maurizio Grassano and Maura Brunetti and Letizia Mazzini and Fabiola De Marchi and Cecilia Simonini and Nicola Fini and Marco Vinceti and Marcello Pinti and Adriano Chiò and Andrea Calvo and Jessica Mandrioli},

doi = {10.1007/s00415-023-11963-0},

issn = {1432-1459},

year  = {2023},

date = {2023-12-01},

journal = {J Neurol},

volume = {270},

number = {12},

pages = {6081--6092},

abstract = {BACKGROUND: Uncovering distinct features and trajectories of amyotrophic lateral sclerosis (ALS) associated with SOD1 mutations (SOD1-ALS) can provide valuable insights for patient' counseling and stratification for trials, and interventions timing. Our study aims to pinpoint distinct clinical characteristics of SOD1-ALS by delving into genotype-phenotype correlations and factors that potentially impact disease progression.nnMETHODS: This is a retrospective observational study of a SOD1-ALS cohort from two Italian registers situated in the regions of Emilia-Romagna, Piedmont and Valle d'Aosta.nnRESULTS: Out of 2204 genotyped ALS patients, 2.5% carried SOD1 mutations, with a M:F ratio of 0.83. SOD1-ALS patients were younger, and more frequently reported a family history of ALS and/or FTD. SOD1-ALS had a longer survival compared to patients without ALS-associated gene mutations. However, here was considerable variability in survival across distinct SOD1 mutations, with an average survival of less than a year for the L39V, G42S, G73S, D91N mutations. Among SOD1-ALS, multivariate analysis showed that, alongside established clinical prognostic factors such as advanced age at onset and high progression rate at diagnosis, mutations located in exon 2 or within highly conserved gene positions predicted worse survival. Conversely, among comorbidities, cancer history was independently associated with longer survival.nnINTERPRETATION: Within the context of an overall slower disease, SOD1-ALS exhibits some degree of heterogeneity linked to the considerable genetic diversity arising from the multitude of potential mutations sites and specific clinical prognostic factors, including cancer history. Revealing the factors that modulate the phenotypic heterogeneity of SOD1-ALS could prove advantageous in improving the efficacy of upcoming therapeutic approaches.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37713806,

title = {Influence of dietary patterns on urinary excretion of cadmium in an Italian population: A cross-sectional study},

author = {Teresa Urbano and Pietro Verzelloni and Marcella Malavolti and Sabrina Sucato and Elisa Polledri and Claudia Agnoli and Sabina Sieri and Nicoletta Natalini and Cristina Marchesi and Silvia Fustinoni and Marco Vinceti and Tommaso Filippini},

doi = {10.1016/j.jtemb.2023.127298},

issn = {1878-3252},

year  = {2023},

date = {2023-12-01},

journal = {J Trace Elem Med Biol},

volume = {80},

pages = {127298},

abstract = {INTRODUCTION: Cadmium is a toxic heavy metal with detrimental effects on human health. Apart from smoking and occupational factors, diet is the main source of cadmium. However, the relation between adherence to so-called "healthy" dietary patterns and cadmium exposure has not been investigated in detail. In this study, we aimed at assessing such association in a Northern Italian population.nnMETHODS: Using a cross-sectional study design, we investigated a population of non-smokers aged 30-60 years in the period 2017-2019. Each subject completed a validated food frequency questionnaire (FFQ) in order to estimate adherence to four dietary patterns, namely the Dietary Approach to Stopping Hypertension-DASH diet, Greek Mediterranean Index-GMI, the Italian Mediterranean Index-IMI, and the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet. We collected a fasting morning urinary sample to measure urinary levels of cadmium and cotinine. The association between increasing adherence to dietary patterns and cadmium exposure was evaluated using a cubic spline regression non-linear model and adjusting for relevant confounders (age, sex, body mass index, urinary cotinine levels, intake of fiber, and alcohol).nnRESULTS: We recruited 137 participants (males/females: 62/75) with median (interquartile range-IQR) age of 47 (IQR: 43-53) years. Median scores for the investigated dietary patterns were 24 (IQR: 21-28), 4 (IQR: 3-6), 4 (IQR: 3-5), and 7.5 (IQR: 6.5-8.5) for DASH, GMI, IMI and MIND diets, respectively. The median urinary cadmium level was 0.21 μg/L (IQR: 0.11-0.34 μg/L). Spline regression analysis showed an inverse linear association between increasing adherence to the DASH and MIND diets and urinary cadmium levels, reaching a plateau at high adherence scores, approximately > 25 and > 9 for DASH and MIND diets, respectively. An increase of cadmium exposure with increasing MIND score also emerged. Conversely, the association was almost null for IMI, and slightly positive for GMI.nnCONCLUSIONS: The present findings suggest that increasing adherence to the DASH and MIND diets are associated with decreased cadmium levels only at moderate level. Overall, these results indicate that public health strategies, including the decrease of cadmium contamination in healthy foods should be implemented.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37777140,

title = {GRADE GUIDANCE 38: Updated guidance for rating up certainty of evidence due to a dose-response gradient},

author = {M Hassan Murad and Jos Verbeek and Lukas Schwingshackl and Tommaso Filippini and Marco Vinceti and Elie A Akl and Rebecca L Morgan and Reem A Mustafa and Dena Zeraatkar and Emily Senerth and Renee Street and Lifeng Lin and Yngve Falck-Ytter and Gordon Guyatt and Holger J Schünemann and },

doi = {10.1016/j.jclinepi.2023.09.011},

issn = {1878-5921},

year  = {2023},

date = {2023-12-01},

journal = {J Clin Epidemiol},

volume = {164},

pages = {45--53},

abstract = {INTRODUCTION: This updated guidance from the Grading of Recommendations Assessment, Development, and Evaluation addresses rating up certainty of evidence due to a dose-response gradient (DRG) observed in synthesis of intervention and exposure studies.nnSTUDY DESIGN AND SETTING: This guidance was developed using iterative discussions and consensus in multiple meetings and was presented to attendees of the Grading of Recommendations Assessment, Development, and Evaluation Working Group meeting for feedback in November 2022 and for final approval in May 2023.nnRESULTS: The guidance consists of two steps. The first is to determine whether the DRG is credible. We describe five items for assessing credibility: a) is DRG identified using a proper analytical approach; b) is confounding the cause of the DRG; c) is there serious concern about ecological bias; d) is the DRG consistent across studies; and e) is there indirect evidence supporting the DRG. The first two of these items are the most critical. If the DRG was judged to be credible, then the second step is to apply the DRG domain and consider rating up, but only by one level due to the concern about residual confounding.nnCONCLUSION: Systematic review authors should only rate up certainty in evidence when a DRG is deemed credible.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37861949,

title = {Fluoride Exposure and Skeletal Fluorosis: a Systematic Review and Dose-response Meta-analysis},

author = {Federica Veneri and Inga Iamandii and Marco Vinceti and Linda S Birnbaum and Luigi Generali and Ugo Consolo and Tommaso Filippini},

doi = {10.1007/s40572-023-00412-9},

issn = {2196-5412},

year  = {2023},

date = {2023-12-01},

journal = {Curr Environ Health Rep},

volume = {10},

number = {4},

pages = {417--441},

abstract = {PURPOSE OF REVIEW: We performed a systematic review and meta-analysis on the relation between fluoride exposure and skeletal fluorosis (SF) using a novel statistical methodology for dose-response modeling.nnRECENT FINDINGS: Skeletal fluorosis, a major health issue that is endemic in some regions, affects millions of people worldwide. However, data regarding the dose-response relation between fluoride exposure and SF are limited and outdated. We included twenty-three studies in the meta-analysis. When comparing the highest versus the lowest fluoride category, the summary risk ratio (RR) for SF prevalence was 2.05 (95% CI 1.60; 2.64), with a value of 2.73 (95% CI 1.92; 3.90) for drinking water and 1.40 (95% CI 0.90; 2.17) for urinary fluoride. The RR by the risk of bias (RoB) was 2.37 (95% CI 1.56; 3.58) and 1.78 (95% CI 1.34; 2.36) for moderate and high RoB studies, respectively. The dose-response curve based on a one-stage cubic spline regression model showed an almost linear positive relation between exposure and SF occurrence starting from relatively low concentrations up to 5 mg/L and 2.5 mg/L, respectively, for water and urinary fluoride, with no substantial increase above this threshold. The RR for developing moderate-severe forms increases at 5.00 mg/L and 2.5 mg/L of water and urinary fluoride, respectively. Better-quality studies are needed to confirm these results, but greater attention should be given to water fluoride levels to prevent SF, in addition to the other potential adverse effects of fluoride exposure.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38042158,

title = {Social disparities and unhealthy lifestyles increase risk of dementia, particularly at a young age},

author = {Tommaso Filippini and Marco Vinceti},

doi = {10.1016/S2666-7568(23)00233-7},

issn = {2666-7568},

year  = {2023},

date = {2023-12-01},

journal = {Lancet Healthy Longev},

volume = {4},

number = {12},

pages = {e660--e661},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38046202,

title = {Safety of lacto-N-fucopentaose I/2'-fucosyllactose (LNFP-I/2'-FL) mixture as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Carmen Peláez and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Paolo Colombo and Estefanía Noriega Fernández and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8412},

issn = {1831-4732},

year  = {2023},

date = {2023-12-01},

journal = {EFSA J},

volume = {21},

number = {12},

pages = {e8412},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on lacto-N-fucopentaose I (LNFP-I)/2'-fucosyllactose (2'-FL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharides (HiMO) LNFP-I and 2'-FL, but it also contains d-lactose, lacto-N-tetraose, difucosyllactose, 3-fucosyllactose, LNFP-I fructose isomer, 2'-fucosyl-d-lactulose, l-fucose and 2'-fucosyl-d-lactitol, and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain ( K-12 DH1 MDO MP2173b) of  K-12 DH1 (DSM 4235). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant formula (IF) and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements (FS). The target population is the general population. The anticipated daily intake of LNFP-I from use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. Overall, the anticipated daily intake of LNFP-I from the NF as a food ingredient at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake in breastfed infants on a body weight basis is expected to be safe also for other population groups. The anticipated 2'-FL intake is generally rather low. The use of the NF in FS is not intended if other foods with added NF components or human milk (for infants and young children) are consumed on the same day. The Panel concludes that the NF, a mixture of LNFP-I and 2'-FL, is safe under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38075631,

title = {Scientific opinion on the tolerable upper intake level for manganese},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan de Henauw and Karen-Ildico Hirsch-Ernst and Helle Katrine Knutsen and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Julia Bornhorst and Francesco Cubadda and Aymeric Dopter and Rex FitzGerald and Agnès de Sesmaisons Lecarré and Pedro das Neves Ferreira and Lucia Fabiani and Zsuzsanna Horvath and Leonard Matijević and Androniki Naska},

doi = {10.2903/j.efsa.2023.8413},

issn = {1831-4732},

year  = {2023},

date = {2023-12-01},

journal = {EFSA J},

volume = {21},

number = {12},

pages = {e8413},

abstract = {Following a request from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for manganese. Systematic reviews of the literature of human and animal data were conducted to assess evidence regarding excess manganese intake (including authorised manganese salts) and the priority adverse health effect, i.e. manganese-induced neurotoxicity. Available human and animal studies support neurotoxicity as a critical effect, however, data are not sufficient and suitable to characterise a dose-response relationship and identify a reference point for manganese-induced neurotoxicity. In the absence of adequate data to establish an UL, estimated background dietary intakes (i.e. manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥ 18 years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38075633,

title = {Safety of oil from  (strain TKD-1) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Emanuela Turla and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8414},

issn = {1831-4732},

year  = {2023},

date = {2023-12-01},

journal = {EFSA J},

volume = {21},

number = {12},

pages = {e8414},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of  sp. (TKD-1) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283.  sp. is a single-cell microalga. The strain TKD-1, used by the applicant (ATK Biotech Co. Ltd.), belongs to the species . The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 53%-61% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20-50 mg/100 kcal.  was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from  sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38075635,

title = {Safety of oil from  sp. (strain CABIO-A-2) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Emanuela Turla and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8415},

issn = {1831-4732},

year  = {2023},

date = {2023-12-01},

journal = {EFSA J},

volume = {21},

number = {12},

pages = {e8415},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of  sp. (strain CABIO-A-2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. . sp. is a single-cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%-44% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20-50 mg/100 kcal. The evidence provided demonstrated that the strain . sp. CABIO-A-2 is phylogenetically closely related to the strain  sp. ATCC 20888. The assessment of some already authorised . sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90-day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA-oils derived from strains belonging to the genus , its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38145739,

title = {Residential exposure to magnetic fields from transformer stations and risk of childhood leukemia},

author = {Marcella Malavolti and Carlotta Malagoli and Lauren A Wise and Maurizio Poli and Barbara Notari and Irene Taddei and Sara Fabbi and Sergio Teggi and Erica Balboni and Alessia Pancaldi and Giovanni Palazzi and Marco Vinceti and Tommaso Filippini},

doi = {10.1016/j.envres.2023.118043},

issn = {1096-0953},

year  = {2023},

date = {2023-12-01},

journal = {Environ Res},

volume = {245},

pages = {118043},

abstract = {BACKGROUND: Several studies have documented an increased risk of leukemia among children exposed to magnetic fields from high-voltage power lines, with some evidence of dose-response relation. However, findings in some studies have been inconsistent, and data on the effects of different sources of exposure are lacking. In this study, we evaluated the relation of childhood leukemia risk to exposure to magnetic fields from transformer stations.nnMETHODS: We conducted a population-based case-control study in a pediatric population of two Northern Italian provinces of Modena and Reggio Emilia. We included 182 registry-identified childhood leukemia cases diagnosed during 1998-2019 and 726 population controls matched on sex, year of birth, and province of residence. We assessed exposure by calculating distance from childhood residence to the nearest transformer station within a geographical information system, computing disease odds ratios (ORs) and 95% confidence intervals (CIs) using conditional logistic regression, adjusting for potential confounders. We evaluated exposure using two buffers (15 m and 25 m radius) and assessed two case groups: leukemia (all subtypes) and acute lymphoblastic leukemia (ALL).nnRESULTS: Residing within 15 m of a transformer station (vs. ≥15 m) was not appreciably associated with risk of leukemia (all subtypes) or ALL. We found similar results using a less stringent exposure buffer (25 m). Among children aged ≥5 years, the adjusted ORs were 1.3 (95% CI 0.1-12.8) for leukemia and 1.3 (95% CI 0.1-12.4) for ALL using the 15 m buffer, while they were 1.7 (95% CI 0.4-7.0) for leukemia and 0.6 (95% CI 0.1-4.8) for ALL using the 25 m buffer.nnCONCLUSIONS: While we found no overall association between residential proximity to transformer stations and childhood leukemia, there was some evidence for elevated risk of childhood leukemia among children aged ≥5 years. Precision was limited by the low numbers of exposed children.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38150803,

title = {Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and exposure to selenium species: A cross-sectional study},

author = {Teresa Urbano and Tommaso Filippini and Marcella Malavolti and Silvia Fustinoni and Bernhard Michalke and Lauren A Wise and Marco Vinceti},

doi = {10.1016/j.nutres.2023.12.002},

issn = {1879-0739},

year  = {2023},

date = {2023-12-01},

journal = {Nutr Res},

volume = {122},

pages = {44--54},

abstract = {Selenium is a trace element found in many chemical forms. Selenium and its species have nutritional and toxicologic properties, some of which may play a role in the etiology of neurological disease. We hypothesized that adherence to the Mediterranean-Dietary Approach to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) diet could influence intake and endogenous concentrations of selenium and selenium species, thus contributing to the beneficial effects of this dietary pattern. We carried out a cross-sectional study of 137 non-smoking blood donors (75 females and 62 males) from the Reggio Emilia province, Northern Italy. We assessed MIND diet adherence using a semiquantitative food frequency questionnaire. We assessed selenium exposure through dietary intake and measurement of urinary and serum concentrations, including speciation of selenium compound in serum. We fitted non-linear spline-based regression models to investigate the association between MIND diet adherence and selenium exposure concentrations. Adherence to the MIND diet was positively associated with dietary selenium intake and urinary selenium excretion, whereas it was inversely associated with serum concentrations of overall selenium and organic selenium, including serum selenoprotein P-bound selenium, the most abundant circulating chemical form of the metalloid. MIND diet adherence also showed an inverted U-shaped relation with inorganic selenium and particularly with its hexavalent form, selenate. Our results suggest that greater adherence to the MIND diet is non-linearly associated with lower circulating concentrations of selenium and of 2 potentially neurotoxic species of this element, selenoprotein P and selenate. This may explain why adherence to the MIND dietary pattern may reduce cognitive decline.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37842553,

title = {Effect of tauroursodeoxycholic acid on survival and safety in amyotrophic lateral sclerosis: a retrospective population-based cohort study},

author = {Elisabetta Zucchi and Umberto Maria Musazzi and Guido Fedele and Ilaria Martinelli and Giulia Gianferrari and Cecilia Simonini and Nicola Fini and Andrea Ghezzi and Maria Caputo and Elisabetta Sette and Veria Vacchiano and Lucia Zinno and Pietro Anceschi and Elena Canali and Marco Vinceti and Salvatore Ferro and Jessica Mandrioli and },

doi = {10.1016/j.eclinm.2023.102256},

issn = {2589-5370},

year  = {2023},

date = {2023-11-01},

journal = {EClinicalMedicine},

volume = {65},

pages = {102256},

abstract = {BACKGROUND: Oral tauroursodeoxycholic acid (TUDCA) is a commercial drug currently tested in patients with amyotrophic lateral sclerosis (ALS) both singly and combined with sodium phenylbutyrate. This retrospective study aimed to investigate, in a real-world setting, whether TUDCA had an impact on the overall survival of patients with ALS who were treated with this drug compared to those patients who received standard care only.nnMETHODS: This propensity score-matched study was conducted in the Emilia Romagna Region (Italy), which has had an ALS regional registry since 2009. Out of 627 patients with ALS diagnosed from January 1st, 2015 to June 30th, 2021 and recorded in the registry with available information on death/tracheostomy, 86 patients took TUDCA and were matched in a 1:2 ratio with patients who received only usual care according to age at onset, sex, phenotype, diagnostic latency, ALS Functional Rating Scale-Revised (ALSFRS-R) at first visit, disease progression rate at first visit, and BMI at diagnosis. The primary outcome was survival difference (time from onset of symptoms to tracheostomy/death) between TUDCA exposed and unexposed patients.nnFINDINGS: A total of 86 patients treated with TUDCA were matched to 172 patients who did not receive treatment. TUDCA-exposed patients were stratified based on dosage (less than or equal to 1000 mg/day or greater) and duration (less than or equal to 12 months or longer) of treatment. The median overall survival was 49.6 months (95% CI 41.7-93.5) among those treated with TUDCA and 36.2 months (95% CI 32.7-41.6) in the control group, with a reduced risk of death observed in patients exposed to a higher dosage (defined as ≥ 1000 mg/day) of TUDCA (HR 0.56; 95% CI 0.38-0.83; p = 0.0042) compared to both the control group and those with lower TUDCA dosages (defined as < 1000 mg/day). TUDCA was generally well-tolerated, except for a minority of patients (n = 7, 8.1%) who discontinued treatment due to side effects, primarily gastrointestinal and mild in severity; only 2 adverse events required hospital access but resolved without sequelae.nnINTERPRETATION: In this population-based exploratory study, patients with ALS who were treated with TUDCA may have prolonged survival compared to patients receiving standard care only. Additional prospective randomized studies are needed to confirm the efficacy and safety of this drug.nnFUNDING: Emilia-Romagna Region.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37955037,

title = {Safety of the extension of use of 2'-fucosyllactose (2'-FL) as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Carmen Peláez and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Paolo Colombo and Estefanía Noriega Fernández and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8334},

issn = {1831-4732},

year  = {2023},

date = {2023-11-01},

journal = {EFSA J},

volume = {21},

number = {11},

pages = {e08334},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of the extension of use of 2'-fucosyllactose (2'-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient in several food categories, including infant formula (IF) and follow-on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF and FOF. EFSA estimated the anticipated daily intake of the NF from the proposed extension of use, including the already authorised conditions of use in other food categories. Additionally, a new intake estimate limited to the already authorised conditions of use of the NF was carried out following EFSA's current approach. The estimated daily intake of the NF from high consumption of IF alone at the proposed maximum use level in infants < 16 weeks of age is similar to the estimated natural highest mean daily intake of 2'-FL from human milk in breastfed infants. The estimated highest P95 daily intakes of the NF from the proposed extension of use in IF and FOF (including the authorised uses in other food categories) and from the already authorised conditions of use, are comparable and both higher than the estimated natural highest mean daily intake of 2'-FL from human milk in infants and to a lesser extent in young children. The Panel considers that the proposed extension of use of the NF in IF and FOF only marginally affects the highest P95 daily intake estimate from the authorised conditions of use, and therefore does not affect the safety of the NF. The Panel concludes that the NF, 2'-FL, is safe under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37965303,

title = {Scientific opinion on the tolerable upper intake level for folate},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan de Henauw and Karen-Ildico Hirsch-Ernst and Helle Katrine Knutsen and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Marta Crous-Bou and Anne Molloy and Laura Ciccolallo and Agnès de Sesmaisons Lecarré and Lucia Fabiani and Zsuzsanna Horvath and Nena Karavasiloglou and Androniki Naska},

doi = {10.2903/j.efsa.2023.8353},

issn = {1831-4732},

year  = {2023},

date = {2023-11-01},

journal = {EFSA J},

volume = {21},

number = {11},

pages = {e08353},

abstract = {Following a request from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for folic acid/folate. Systematic reviews of the literature were conducted to assess evidence on priority adverse health effects of excess intake of folate (including folic acid and the other authorised forms, (6S)-5-methyltetrahydrofolic acid glucosamine and l-5-methyltetrahydrofolic acid calcium salts), namely risk of cobalamin-dependent neuropathy, cognitive decline among people with low cobalamin status, and colorectal cancer and prostate cancer. The evidence is insufficient to conclude on a positive and causal relationship between the dietary intake of folate and impaired cognitive function, risk of colorectal and prostate cancer. The risk of progression of neurological symptoms in cobalamin-deficient patients is considered as the critical effect to establish an UL for folic acid. No new evidence has been published that could improve the characterisation of the dose-response between folic acid intake and resolution of megaloblastic anaemia in cobalamin-deficient individuals. The ULs for folic acid previously established by the Scientific Committee on Food are retained for all population groups, i.e. 1000 μg/day for adults, including pregnant and lactating women, 200 μg/day for children aged 1-3 years, 300 μg/day for 4-6 years, 400 μg/day for 7-10 years, 600 μg/day for 11-14 years and 800 μg/day for 15-17 years. A UL of 200 μg/day is established for infants aged 4-11 months. The ULs apply to the combined intake of folic acid, (6S)-5-methyltetrahydrofolic acid glucosamine and l-5-methyltetrahydrofolic acid calcium salts, under their authorised conditions of use. It is unlikely that the ULs for supplemental folate are exceeded in European populations, except for regular users of food supplements containing high doses of folic acid/5-methyl-tetrahydrofolic acid salts.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38027444,

title = {Safety of a change in specifications of the novel food oleoresin from  containing astaxanthin pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Miguel Prieto Maradona and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Wolfgang Gelbmann and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8338},

issn = {1831-4732},

year  = {2023},

date = {2023-11-01},

journal = {EFSA J},

volume = {21},

number = {11},

pages = {e08338},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of a change of specifications of the novel food (NF) oleoresin from  containing astaxanthin (ATX) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient for the use in food supplements as defined in Directive 2002/46EC in accordance to Regulation (EU) 2017/2470. The NF concerns an oleoresin which contains ~ 10% ATX, obtained by supercritical CO extraction of the homogenised and dried biomass of cultivated . This NF has been assessed by the Panel in 2014. With the present dossier, the applicant proposed to lower the minimum specification limits for protein and ATX monoesters for the NF, and to increase the maximum specification limit for the relative amount of ATX diesters in total ATX. An increase of the maximum specification limit for the 9-cis isomer is also applied for. Although the data are limited regarding bioavailability and distribution in humans of these three naturally occurring ATX isomers, the available  and  data suggest that the 13-cis rather than the 9-cis ATX is selectively absorbed, i.e. has a higher bioavailability and/or possibly emerges from isomerisation of all-trans ATX. The Panel notes that the toxicity of the individual ATX isomers has not been studied individually. However, the ADI of 0.2 mg/kg, which was established for synthetic ATX and ATX from , applies also for ATX in the oleoresin from  with the proposed changes of specifications. The Panel concludes that the NF, oleoresin from  containing ATX, is safe with the proposed specification limits.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38027450,

title = {Safety of 2'-fucosyllactose (2'-FL) produced by a derivative strain ( SGR5) of  W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Carmen Peláez and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Paolo Colombo and Estefanía Noriega Fernández and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8333},

issn = {1831-4732},

year  = {2023},

date = {2023-11-01},

journal = {EFSA J},

volume = {21},

number = {11},

pages = {e08333},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 2'-fucosyllactose (2'-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 2'-FL, but it also contains d-lactose, l-fucose, fucosylgalactose, difucosyllactose, d-glucose and d-galactose, and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain ( SGR5) of  W (ATCC 9637). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant applies for the same use and use levels as already authorised for 2'-FL and included in the Union list of NFs, with the general population as target population. The Panel noted that the available intake estimate is not recent (2015) and based on a different database (2008-2010 UK data) than that used by EFSA. For this reason, the Panel decided to perform a new intake estimate according to the current EFSA approach. The Panel notes that the highest P95 daily intake of the NF from the use as food ingredient is higher than the estimated natural highest mean daily intake in breastfed infants and marginally higher in young children. The applicant also proposes to extend the use of 2'-FL in food supplements (FS) for infants at the use level of 1.2 g/day. The resulting estimated intake in infants from the proposed use in FS is within the natural intake of 2'-FL in breastfed infants. FS are not intended to be used if other foods with added 2'-FL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38035143,

title = {Safety of an extension of use of  yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Reinhard Ackerl and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8416},

issn = {1831-4732},

year  = {2023},

date = {2023-11-01},

journal = {EFSA J},

volume = {21},

number = {11},

pages = {e8416},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an extension of use of  ()  yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in a number of food categories, in foods for special medical purposes and in foods for total diet replacement for weight control. In 2018,  was attributed the qualified presumption of safety (QPS) status for production purposes, including food and feed products based on biomass. The Panel considers that the data provided sufficient information with respect to the stability of the NF, also when used as a food ingredient. The concentrations of the analysed processing contaminants do not raise safety concerns. The Panel also considers that consumption of the NF is not nutritionally disadvantageous under the proposed conditions of use. The Panel concludes that the NF,  yeast biomass, is safe under the proposed conditions of use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38035146,

title = {Safety of monosodium salt of l-5-methyltetrahydrofolic acid as a novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Margarita Aguilera-Gómez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Miguel Prieto Maradona and Rosangela Marchelli and Monika Neuhäuser-Berthold and Morten Poulsen and Josef Rudolf Schlatter and Alexandros Siskos and Henk van Loveren and Leonard Matijević and Helle Katrine Knutsen},

doi = {10.2903/j.efsa.2023.8417},

issn = {1831-4732},

year  = {2023},

date = {2023-11-01},

journal = {EFSA J},

volume = {21},

number = {11},

pages = {e8417},

abstract = {Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on monosodium salt of l-5-methyltetrahydrofolic acid (5-MTHF) as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006. The NF is produced by chemical synthesis and consists of at least 95% (w/w) of 5-MTHF and 4%-5% (w/w) of sodium. It is proposed to be used as a partial or complete substitute to folic acid and other sources of added folate in a number of food categories. The production process, composition, specifications and stability of the NF do not raise safety concerns. When used as an ingredient in different food matrices, proper processing/storage conditions need to be considered to preserve the stability of the NF. Regarding bioavailability, the Panel considers that the NF readily dissociates into Na and l-methylfolate ions, which subsequently are absorbed and enter the circulation. Thus, the bioavailability of 5-MTHF from the NF is comparable to that of other currently authorised salts of 5-MTHF. The Panel considers that the consumption of the NF is not nutritionally disadvantageous as long as the combined intake of the NF and the other supplemental forms of folate under their authorised conditions of use is below the ULs established for the different age groups of the general population. The Panel concludes that the NF is safe under the proposed conditions of use. The Panel also concludes that the NF is a source from which folate is bioavailable.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37850766,

title = {Evaluation of an interprofessional education intervention in partnership with patient educators},

author = {Paola Ferri and Chiara Vivarelli and Fausta Lui and Sara Alberti and Sergio Rovesti and Alice Serafini and Rosaria Di Lorenzo and Gabriele Amati and Maria Stella Padula},

doi = {10.23750/abm.v94i5.14825},

issn = {2531-6745},

year  = {2023},

date = {2023-10-01},

journal = {Acta Biomed},

volume = {94},

number = {5},

pages = {e2023250},

abstract = {BACKGROUND AND AIM: Patient involvement in interprofessional education is a novel approach to building collaborative and empathic skills in students. However, this area of teaching is lacking in rigorous studies. The project aimed to evaluate whether an interprofessional education intervention in partnership with patient educators (IPE-PE) would increase readiness for interprofessional learning and empathy in health sciences students.nnMETHODS: This is the report of a didactic innovation project. Participants included 310 undergraduate health sciences students who took part in an IPE-PE intervention. Data were collected before and after the training, using the Readiness for Interprofessional Learning Scale (RIPLS) and the Jefferson Scale of Empathy-Health Professions Student version (JSE-HPS). Only at the end of the intervention, a data collection form was administered to explore the value of the patient educator in the training and to investigate the socio-demographic variables.nnRESULTS: The mean age of participants was 21±3.2 SD years and 76% were female. A paired t-test showed significant changes from before to after the IPE-PE in the mean total RIPLS score (42.7±5.8 SD vs 44.62±5.9 SD, P<0.001) and the mean total JSE-HPS score (112.7±12.5 SD vs 116.03±12.8 SD, P<0.001).            Conclusions: Our students reported that IPE-PE had helped them to become more effective healthcare team members, to think positively about other professionals, and to gain empathic understanding of the perspective of the person being cared for. The results of the project confirm that the intervention promoted the development of empathy, fostering a better understanding of the patient-centred perspective.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37893846,

title = {Group Therapy with Peer Support Provider Participation in an Acute Psychiatric Ward: 1-Year Analysis},

author = {Rosaria Di Lorenzo and Jessica D'Amore and Sara Amoretti and Jessica Bonisoli and Federica Gualtieri and Ilaria Ragazzini and Sergio Rovesti and Paola Ferri},

doi = {10.3390/healthcare11202772},

issn = {2227-9032},

year  = {2023},

date = {2023-10-01},

journal = {Healthcare (Basel)},

volume = {11},

number = {20},

abstract = {(1) Background: Group psychotherapy improves therapeutic process, fosters identification with others, and increases illness awareness; (2) Methods: In 40 weekly group sessions held in an acute psychiatric ward during one year, we retrospectively evaluated the inpatients' participation and the demographic and clinical variables of the individuals hospitalized in the ward, the group type according to Bion's assumptions, the main narrative themes expressed, and the mentalization processes by using the Mentalization-Based Therapy-Group Adherence and Quality Scale (MBT-G-AQS); (3) Results: The "working" group was the prevailing one, and the most represented narrative theme was "treatment programs"; statistically significant correlations were found between the group types according to Bion's assumptions and the main narrative themes (Fisher's exact,  = 0.007); at our multivariate linear regression, the MBT-G-AQS overall occurrence score (dependent variable) was positively correlated with the number of group participants (coef. = 14.87;  = 0.011) and negatively with the number of participants speaking in groups (coef. = -16.87,  = 0.025); (4) Conclusion: our study suggests that the group shows consistent defense mechanisms, relationships, mentalization, and narrative themes, which can also maintain a therapeutic function in an acute ward.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid38005996,

title = {SARS-CoV-2 mRNA Vaccine Response in People Living with HIV According to CD4 Count and CD4/CD8 Ratio},

author = {Alessandra Vergori and Alessandro Tavelli and Giulia Matusali and Anna Maria Azzini and Matteo Augello and Valentina Mazzotta and Giovanni Francesco Pellicanò and Andrea Costantini and Antonio Cascio and Andrea De Vito and Lorenzo Marconi and Elda Righi and Assunta Sartor and Carmela Pinnetti and Fabrizio Maggi and Francesca Bai and Simone Lanini and Stefania Piconi and Gabriel Levy Hara and Giulia Marchetti and Maddalena Giannella and Evelina Tacconelli and Antonella d'Arminio Monforte and Andrea Antinori and Alessandro Cozzi-Lepri and On Behalf Of The Vax-Icona-Orchestra Study},

doi = {10.3390/vaccines11111664},

issn = {2076-393X},

year  = {2023},

date = {2023-10-01},

journal = {Vaccines (Basel)},

volume = {11},

number = {11},

abstract = {BACKGROUND: Our aim was to estimate the rates of not achieving a robust/above-average humoral response to the COVID-19 mRNA vaccine in people living with HIV (PLWH) who received ≥2 doses and to investigate the role of the CD4 and CD4/CD8 ratio in predicting the humoral response.nnMETHODS: We evaluated the humoral anti-SARS-CoV-2 response 1-month after the second and third doses of COVID-19 mRNA vaccine as a proportion of not achieving a robust/above-average response using two criteria: (i) a humoral threshold identified as a correlate of protection against SARS-CoV-2 (<90% vaccine efficacy): anti-RBD < 775 BAU/mL or anti-S < 298 BAU/mL, (ii) threshold of binding antibodies equivalent to average neutralization activity from the levels of binding (nAb titer < 1:40): anti-RBD < 870 BAU/mL or anti-S < 1591 BAU/mL. PLWH were stratified according to the CD4 count and CD4/CD8 ratio at first dose. Logistic regression was used to compare the probability of not achieving robust/above-average responses. A mixed linear model was used to estimate the mean anti-RBD titer at various time points across the exposure groups.nnRESULTS: a total of 1176 PLWH were included. The proportions of participants failing to achieve a robust/above-average response were significantly higher in participants with a lower CD4 and CD4/CD8 ratio, specifically, a clearer gradient was observed for the CD4 count. The CD4 count was a better predictor of the humoral response of the primary cycle than ratio. The third dose was pivotal in achieving a robust/above-average humoral response, at least for PLWH with CD4 > 200 cells/mm and a ratio > 0.6.nnCONCLUSIONS: A robust humoral response after a booster dose has not been reached by 50% of PLWH with CD4 < 200 cells mm. In the absence of a validated correlate of protections in the Omicron era, the CD4 count remains the most solid marker to guide vaccination campaigns in PLWH.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37522179,

title = {Alcohol Intake and Blood Pressure Levels: A Dose-Response Meta-Analysis of Nonexperimental Cohort Studies},

author = {Silvia Di Federico and Tommaso Filippini and Paul K Whelton and Marta Cecchini and Inga Iamandii and Giuseppe Boriani and Marco Vinceti},

doi = {10.1161/HYPERTENSIONAHA.123.21224},

issn = {1524-4563},

year  = {2023},

date = {2023-10-01},

journal = {Hypertension},

volume = {80},

number = {10},

pages = {1961--1969},

abstract = {BACKGROUND: Alcohol consumption may increase blood pressure but the details of the relationship are incomplete, particularly for the association at low levels of alcohol consumption, and no meta-analyses are available for nonexperimental cohort studies.nnMETHODS: We performed a systematic search of longitudinal studies in healthy adults that reported on the association between alcohol intake and blood pressure. Our end points were the mean differences over time of systolic (SBP) and diastolic blood pressure (DBP), plotted according to baseline alcohol intake, by using a dose-response 1-stage meta-analytic methodology.nnRESULTS: Seven studies, with 19 548 participants and a median follow-up of 5.3 years (range, 4-12 years), were included in the analysis. We observed a substantially linear positive association between baseline alcohol intake and changes over time in SBP and DBP, with no suggestion of an exposure-effect threshold. Overall, average SBP was 1.25 and 4.90 mm Hg higher for 12 or 48 grams of daily alcohol consumption, compared with no consumption. The corresponding differences for DBP were 1.14 and 3.10 mm Hg. Subgroup analyses by sex showed an almost linear association between baseline alcohol intake and SBP changes in both men and women, and for DBP in men while in women we identified an inverted -shaped association. Alcohol consumption was positively associated with blood pressure changes in both Asians and North Americans, apart from DBP in the latter group.nnCONCLUSIONS: Our results suggest the association between alcohol consumption and SBP is direct and linear with no evidence of a threshold for the association, while for DBP the association is modified by sex and geographic location.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid37829005,

title = {Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006},

author = { and Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and Stefaan De Henauw and Karen Ildico Hirsch-Ernst and Helle Katrine Knutsen and Alexandre Maciuk and Inge Mangelsdorf and Harry J McArdle and Androniki Naska and Kristina Pentieva and Frank Thies and Sophia Tsabouri and Marco Vinceti and Jean-Louis Bresson and Thibault Fiolet and Alfonso Siani},

doi = {10.2903/j.efsa.2023.8239},

issn = {1831-4732},

year  = {2023},

date = {2023-10-01},

journal = {EFSA J},

volume = {21},

number = {10},

pages = {e08239},

abstract = {Following an application from Greenleaf Medical AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Appethyl® and reduction of body weight. Appethyl® is an aqueous extract from spinach leaves standardised by the manufacturing process and its lipase/colipase inhibition capacity . The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight/obese individuals. The applicant identified a total of three human intervention studies that investigated the effects of Appethyl® on body weight as being pertinent to the claim. In weighing the evidence, the Panel took into account that Appethyl® (5 g/day for 12 weeks) had no effect on body weight as compared to placebo under minimal dietary counselling and moderate physical activity, and that no beneficial physiological effects are to be expected for the target population of overweight/obese individuals from the weight loss that could be attributed to the intervention with Appethyl® under predefined energy restriction and moderate physical activity. The Panel also considered that the effect of Appethyl® (5 g/day for 24 weeks) on body weight maintenance after initial weight loss shown in one study has not been replicated in different settings, which questions the external validity of the results, and that no evidence was provided for a plausible mechanism by which daily consumption of Appethyl® could exert a sustained effect on body weight in humans. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of Appethyl® and a reduction of body weight under the conditions of use proposed by the applicant.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}