Safety of the extension of use of plant sterol esters as a novel food pursuant to Regulation (EU) 2015/2283

Peer reviewedPublisher PD

Scientific opinion on the safety of selenite triglycerides as a source of selenium added for nutritional purposes to food supplements

© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewedPublisher PD

Safety of astaxanthin for its use as a novel food in food supplements

Peer reviewedPublisher PD

Hydrogel Tracer Beads: The Development, Modification, and Testing of an Innovative Tracer for Better Understanding LNAPL Transport in Karst Aquifers

The goal of this specific research task is to develop proxy tracers that mimic contaminant movement to better understand and predict contaminant fate and transport in karst aquifers. Hydrogel tracer beads are transported as a separate phase than water and can used as a proxy tracer to mimic the transport of non-aqueous phase liquids (NAPL). They can be constructed with different densities, sizes & chemical attributes. This poster describes the creation and optimization of the beads and the field testing of buoyant beads, including sampling, tracer analysis, and quantitative analysis. The buoyant beads are transported ahead of the dissolved solutes, suggesting that light NAPL (LNAPL) transport in karst may occur faster than predicted from traditional tracing techniques. The hydrogel beads were successful in illustrating this enhanced transport

Functional and structural analysis of AT-specific minor groove binders that disrupt DNA–protein interactions and cause disintegration of the Trypanosoma brucei kinetoplast

Trypanosoma brucei, the causative agent of sleeping sickness (Human African Trypanosomiasis, HAT), contains a kinetoplast with the mitochondrial DNA (kDNA), comprising of >70% AT base pairs. This has prompted studies of drugs interacting with AT-rich DNA, such as the N-phenylbenzamide bis(2-aminoimidazoline) derivatives 1 [4-((4,5-dihydro-1H-imidazol-2-yl)amino)-N-(4-((4,5-dihydro-1H-imidazol-2-yl)amino)phenyl)benzamide dihydrochloride] and 2 [N-(3-chloro-4-((4,5-dihydro-1H-imidazol-2-yl)amino)phenyl)-4-((4,5-dihydro-1H-imidazol-2-yl)amino)benzamide] as potential drugs for HAT. Both compounds show in vitro effects against T. brucei and in vivo curative activity in a mouse model of HAT. The main objective was to identify their cellular target inside the parasite. We were able to demonstrate that the compounds have a clear effect on the S-phase of T. brucei cell cycle by inflicting specific damage on the kinetoplast. Surface plasmon resonance (SPR)–biosensor experiments show that the drug can displace HMG box-containing proteins essential for kDNA function from their kDNA binding sites. The crystal structure of the complex of the oligonucleotide d[AAATTT]2 with compound 1 solved at 1.25 Å (PDB-ID: 5LIT) shows that the drug covers the minor groove of DNA, displaces bound water and interacts with neighbouring DNA molecules as a cross-linking agent. We conclude that 1 and 2 are powerful trypanocides that act directly on the kinetoplast, a structure unique to the order Kinetoplastida

Cadmium-Related Mortality and Long-Term Secular Trends in the Cadmium Body Burden of an Environmentally Exposed Population

BACKGROUND: Few population studies have reported on the long-term changes in the internal cadmium dose and simultaneously occurring mortality. OBJECTIVE: We monitored blood cadmium (BCd), 24-hr urinary cadmium (UCd), and mortality in an environmentally exposed population. METHODS: Starting from 1985, we followed BCd (until 2003), UCd (until 1996), and mortality (until 2007) among 476 and 480 subjects, randomly recruited from low- exposure areas (LEA) and high-exposure areas (HEA). The last cadmium-producing plant in the HEA closed in 2002. RESULTS: From 1985-1989 to 1991-1996, BCd decreased by 40.3% and 18.9% in the LEA and HEA, respectively (p < 0.0001 for between-area difference). From 1991-1996 until 2001-2003, BCd remained unchanged in the HEA (+ 1.8%) and increased by 19.7% in the LEA (p < 0.0001). Over the entire follow-up period, the annual decrease in BCd averaged 2.7% in the LEA (n = 258) and 1.8% in the HEA (n = 203). From 1985-1989 to 1991-1996, UCd fell by 12.9% in the LEA and by 16.6% in the HEA (p = 0.22), with mean annual decreases of 2.7% (n = 366) and 3.4% (n = 364). Over 20.3 years (median), 206 deaths (21.5%) occurred. At baseline, BCd (14.6 vs. 10.2 nmol/L) and UCd (14.1 vs. 8.6 nmol/24-hr) were higher in deaths than in survivors. The risks (p <= 0.04) associated with a doubling of baseline UCd were 20% and 44% for total and noncardiovascular mortality, and 25% and 33% for a doubling of BCd. CONCLUSIONS: Even if zinc-cadmium smelters close, historical environmental contamination remains a persistent source of exposure. Environmental exposure to cadmium increases total and noncardiovascular mortality in a continuous fashion without threshold

Systematic evaluation of the efficacy-effectiveness gap of systemic treatments in extensive disease small cell lung cancer

Purpose The aim of this study is to assess how clinical outcomes in real-world (effectiveness) correspond to the outcomes in clinical trials (efficacy) of systemic treatments for extensive disease small cell lung cancer (ED SCLC). Methods All patients diagnosed with ED SCLC between 2008 and 2014 in six Dutch large teaching hospitals (Santeon network) were identified and followed-up from date of diagnosis until death or end of data collection. For every patient, an efficacy-effectiveness factor (EE factor) was calculated by dividing individual patients' overall survival (OS) by the pooled median OS assessed from clinical trials with the respective treatment. Results From 792 diagnosed patients, 568 (72%) started with first-line treatment. Overall, the median EE factor was 0.79 (P = 2) and a higher age at diagnosis (age >= 65 years) were independent predictors for a lower EE factor. The EE gap was 43% in patients with both age >= 65 years and ECOG >= 2 (EE factor 0.57). The mean age and the proportion of patients with ECOG >= 2 in real-world were different from those in clinical trials (mean age of 66 versus 62 years, and ECOG >= 2 25% versus 17%; both P <.001). Conclusion OS of patients with ED SCLC treated with systemic therapy in real-world practice is 21% shorter than for patients included in trials. Age at diagnosis and performance status partly explain this gap

Prevalence of severe childhood obesity in England:2006-2013

BACKGROUND: International evidence shows that severe paediatric obesity results in an increased risk of ill health and may require specialised weight management strategies, yet there remains a lack of data on the extent of the problem. OBJECTIVE: To examine the prevalence of severe obesity in children aged 4-5 and 10-11 years, attending English schools between 2006/2007 and 2012/2013. DESIGN: A retrospective analysis of National Child Measurement Programme (NCMP) data. SETTING: Maintained schools in England. PARTICIPANTS: All children aged 4-5 and 10-11 years included in the NCMP dataset. MAIN OUTCOME MEASURES: Prevalence of severe childhood obesity, defined using the 99.6th centile of the British 1990 (UK90) growth reference for body mass index (BMI), analysed by sex, geography, ethnic group and deprivation. RESULTS: The key findings show that in 2012/2013, severe obesity (BMI ≥UK90 99.6th centile) was found in 1.9% of girls and 2.3% of boys aged 4-5 years, and 2.9% of girls and 3.9% of boys aged 10-11 years. Severe obesity prevalence varies geographically and is more prevalent in children from deprived areas, and among those from black ethnic groups. CONCLUSIONS: The findings from this study should help to raise awareness of the prevalence of severe obesity and support the provision of adequate treatment and prevention services both to support children who are already severely obese and reduce the prevalence of extreme weight in the future

Rationale and Design of the Groningen Intervention Study for the Preservation of Cardiac Function with Sodium Thiosulfate after ST-segment Elevation Myocardial Infarction (GIPS-IV) Trial

RATIONALE: Ischemia and subsequent reperfusion cause myocardial injury in patients presenting with ST-segment elevation myocardial infarction (STEMI). Hydrogen sulfide (H2S) reduces "ischemia-reperfusion injury" in various experimental animal models, but has not been evaluated in humans. This trial will examine the efficacy and safety of the H2S-donor sodium thiosulfate (STS) in patients presenting with a STEMI. STUDY DESIGN: The Groningen Intervention study for the Preservation of cardiac function with STS after STEMI (GIPS-IV) trial (NCT02899364) is a double-blind, randomized, placebo-controlled, multicenter trial, which will enroll 380 patients with a first STEMI. Patients receive STS 12.5 gram intravenously or matching placebo in addition to standard care immediately at arrival at the catheterization laboratory after providing consent. A second dose is administered 6 hours later at the coronary care unit. The primary endpoint is myocardial infarct size as quantified by cardiac magnetic resonance imaging 4 months after randomization. Secondary endpoints include the effect of STS on peak CK-MB during admission and left ventricular ejection fraction and NT-proBNP levels at 4 months follow-up. Patients will be followed-up for 2 years to assess clinical endpoints. CONCLUSIONS: The GIPS-IV trial is the first study to determine the effect of a H2S-donor on myocardial infarct size in patients presenting with STEMI