Publications by authors named "Søren Nielsen"

761 Publications

Statement on the derivation of Health-Based Guidance Values (HBGVs) for regulated products that are also nutrients.

EFSA J 2021 Mar 18;19(3):e06479. Epub 2021 Mar 18.

This Statement presents a proposal for harmonising the establishment of Health-Based Guidance Values (HBGVs) for regulated products that are also nutrients. This is a recurrent issue for food additives and pesticides, and may occasionally occur for other regulated products. The Statement describes the specific considerations that should be followed for establishing the HBGVs during the assessment of a regulated product that is also a nutrient. It also addresses the elements to be considered in the intake assessment; and proposes a decision tree for ensuring a harmonised process for the risk characterisation of regulated products that are also nutrients. The Scientific Committee recommends the involvement of the relevant EFSA Panels and units, in order to ensure an integrated and harmonised approach for the hazard and risk characterisation of regulated products that are also nutrients, considering the intake from all relevant sources.
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http://dx.doi.org/10.2903/j.efsa.2021.6479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970819PMC
March 2021

Monitoring of SARS-CoV-2 infection in mustelids.

EFSA J 2021 Mar 3;19(3):e06459. Epub 2021 Mar 3.

American mink and ferret are highly susceptible to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but no information is available for other mustelid species. SARS-CoV-2 spreads very efficiently within mink farms once introduced, by direct and indirect contact, high within-farm animal density increases the chance for transmission. Between-farm spread is likely to occur once SARS-CoV-2 is introduced, short distance between SARS-CoV-2 positive farms is a risk factor. As of 29 January 2021, SARS-CoV-2 virus has been reported in 400 mink farms in eight countries in the European Union. In most cases, the likely introduction of SARS-CoV-2 infection into farms was infected humans. Human health can be at risk by mink-related variant viruses, which can establish circulation in the community, but so far these have not shown to be more transmissible or causing more severe impact compared with other circulating SARS-CoV-2. Concerning animal health risk posed by SARS-CoV-2 infection the animal species that may be included in monitoring plans are American mink, ferrets, cats, raccoon dogs, white-tailed deer and Rhinolophidae bats. All mink farms should be considered at risk of infection; therefore, the monitoring objective should be early detection. This includes passive monitoring (in place in the whole territory of all countries where animals susceptible to SARS-CoV-2 are bred) but also active monitoring by regular testing. First, frequent testing of farm personnel and all people in contact with the animals is recommended. Furthermore randomly selected animals (dead or sick animals should be included) should be tested using reverse transcriptase-polymerase chain reaction (RT-PCR), ideally at weekly intervals (i.e. design prevalence approximately 5% in each epidemiological unit, to be assessed case by case). Suspected animals (dead or with clinical signs and a minimum five animals) should be tested for confirmation of SARS-CoV-2 infection. Positive samples from each farm should be sequenced to monitor virus evolution and results publicly shared.
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http://dx.doi.org/10.2903/j.efsa.2021.6459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926496PMC
March 2021

ASF Exit Strategy: Providing cumulative evidence of the absence of African swine fever virus circulation in wild boar populations using standard surveillance measures.

EFSA J 2021 Mar 3;19(3):e06419. Epub 2021 Mar 3.

EFSA assessed the role of seropositive wild boar in African swine fever (ASF) persistence. Surveillance data from Estonia and Latvia investigated with a generalised equation method demonstrated a significantly slower decline in seroprevalence in adult animals compared with subadults. The seroprevalence in adults, taking more than 24 months to approach zero after the last detection of ASFV circulation, would be a poor indicator to demonstrate the absence of virus circulation. A narrative literature review updated the knowledge on the mortality rate, the duration of protective immunity and maternal antibodies and transmission parameters. In addition, parameters potentially leading to prolonged virus circulation (persistence) in wild boar populations were reviewed. A stochastic explicit model was used to evaluate the dynamics of virus prevalence, seroprevalence and the number of carcasses attributed to ASF. Secondly, the impact of four scenarios on the duration of ASF virus (ASFV) persistence was evaluated with the model, namely a: (1) prolonged, lifelong infectious period, (2) reduction in the case-fatality rate and prolonged transient infectiousness; (3) change in duration of protective immunity and (4) change in the duration of protection from maternal antibodies. Only the lifelong infectious period scenario had an important prolonging effect on the persistence of ASF. Finally, the model tested the performance of different proposed surveillance strategies to provide evidence of the absence of virus circulation (Exit Strategy). A two-phase approach (Screening Phase, Confirmation Phase) was suggested for the Exit Strategy. The accuracy of the Exit Strategy increases with increasing numbers of carcasses collected and tested. The inclusion of active surveillance based on hunting has limited impact on the performance of the Exit Strategy compared with lengthening of the monitoring period. This performance improvement should be reasonably balanced against an unnecessary prolonged 'time free' with only a marginal gain in performance. Recommendations are provided for minimum monitoring periods leading to minimal failure rates of the Exit Strategy. The proposed Exit Strategy would fail with the presence of lifelong infectious wild boar. That said, it should be emphasised that the existence of such animals is speculative, based on current knowledge.
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http://dx.doi.org/10.2903/j.efsa.2021.6419DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926520PMC
March 2021

Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: .

EFSA J 2021 Feb 3;19(2):e06403. Epub 2021 Feb 3.

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for African Horse Sickness (AHS). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum duration of measures in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, specific details of the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures were assessed were designed and agreed prior to the start of the assessment. In summary, sampling procedures described in the diagnostic manual for AHS were considered efficient for all Equidae considering the high case fatality rate expected. The monitoring period (14 days) was assessed as effective in every scenario, except for those relating to the epidemiological enquiry where the risk manager should consider increasing the monitoring period, based on the awareness of keepers, environmental conditions and the vector abundance in the region. The current protection zone (100 km) comprises more than 95% of the infections from an affected establishment. Both the radius and duration of the zones could be reduced, based on local environmental conditions and the time of year of the first index case. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation relating to AHS.
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http://dx.doi.org/10.2903/j.efsa.2021.6403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856565PMC
February 2021

Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: African Swine Fever.

EFSA J 2021 Jan 31;19(1):e06402. Epub 2021 Jan 31.

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for African Swine Fever (ASF). In this opinion, EFSA and the AHAW Panel of experts reviewed the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, specific details of the model used for the assessment of the laboratory sampling procedures for ASF are presented here. Here, also, the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. In summary, several sampling procedures as described in the diagnostic manual for ASF were considered ineffective and a suggestion to exclude, or to substitute with more effective procedures was made. The monitoring period was assessed as non-effective for several scenarios and a longer monitoring period was suggested to ensure detection of potentially infected herds. It was demonstrated that the surveillance zone comprises 95% of the infections from an affected establishment, and therefore is considered effective. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to ASF.
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http://dx.doi.org/10.2903/j.efsa.2021.6402DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7848183PMC
January 2021

Impact of UHT treatment and storage on liquid infant formula: Complex structural changes uncovered by centrifugal field-flow fractionation with multi-angle light scattering.

Food Chem 2021 Jun 19;348:129145. Epub 2021 Jan 19.

Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3, 2200 Copenhagen, Denmark. Electronic address:

Protein modifications in liquid infant formula (IF) have been widely studied, but distinguishing between heat- and storage-induced structural changes remains challenging. A generic liquid IF was subjected to direct or indirect UHT treatment and stored at 40 °C up to 180 days. Colour and pH were monitored and structural changes were characterised by dynamic light scattering, SDS-PAGE and centrifugal field-flow fractionation (FFF) coupled with multi-angle light scattering (MALS) and UV detectors to evaluate whether heat-induced differences would level out during storage. Both direct- and indirect UHT treatment led to structural changes, where the higher heat load of the indirect UHT treatment caused more pronounced changes. Indications were that storage-induced changes in pH, browning and non-reducible cross-links were not dependent on UHT treatment. However, FFF-MALS-UV analysis allowed characterisation of complex aggregates, where structural changes continued to be most pronounced in indirect UHT treated samples, and different storage-induced aggregation behaviour was observed.
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http://dx.doi.org/10.1016/j.foodchem.2021.129145DOI Listing
June 2021

Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: Highly Pathogenic Avian Influenza.

EFSA J 2021 Jan 18;19(1):e06372. Epub 2021 Jan 18.

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Highly Pathogenic Avian Influenza (HPAI). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, specific details of the model used for the assessment of the laboratory sampling procedures for HPAI are presented here. Here, also, the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. In summary, sampling procedures as described in the diagnostic manual for HPAI were considered efficient for gallinaceous poultry, whereas additional sampling is advised for Anseriformes. The monitoring period was assessed as effective, and it was demonstrated that the surveillance zone comprises 95% of the infections from an affected establishment. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to HPAI.
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http://dx.doi.org/10.2903/j.efsa.2021.6372DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812451PMC
January 2021

BIOLOGICAL VARIATION OF HEMATOLOGY AND BIOCHEMISTRY PARAMETERS FOR THE ASIAN ELEPHANT (), AND APPLICABILITY OF POPULATION-DERIVED REFERENCE INTERVALS.

J Zoo Wildl Med 2020 Nov;51(3):643-651

Ascendis Pharma A/S, 2900 Hellerup, Denmark.

The aim of this study was to objectively evaluate the biological variation of healthy Asian elephant () hematology and biochemistry parameters, therefore enabling evidence-based clinical decision-making to improve patient management. Ten clinically healthy elephants had blood samples collected weekly for 5 wk under standardized conditions. The analytical, between- and within-individual variation, index of individuality, and reference change values were calculated using previously reported methods. Large between-individual variation and small within-individual variation for almost all parameters indicated that individual normal values should be used for interpreting blood results from Asian elephants.
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http://dx.doi.org/10.1638/2020-0007DOI Listing
November 2020

Dynamics of somatic cell count (SCC) and differential SCC during and following intramammary infections.

J Dairy Sci 2021 Mar 15;104(3):3427-3438. Epub 2021 Jan 15.

Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, 1870 Frederiksberg, Denmark.

Somatic cell count is frequently used as an indicator of intramammary infections (IMI) in dairy cattle worldwide. The newly introduced differential SCC (DSCC) can potentially contribute to detection of IMI. The purpose of this study was to investigate the dynamics of SCC and DSCC after IMI. We used a data set with monthly samples from 2 Danish dairy herds through 1 yr, using bacterial culture to identify IMI. The dynamics of SCC and DSCC with regard to IMI were assessed at quarter level following new IMI with each of 3 defined pathogen groups, major, minor, or "other" pathogens, using general additive models. Both SCC and DSCC increased after IMI, with a more pronounced increase if major or other pathogens were detected compared with minor pathogens. We found that DSCC increased after IMI with other pathogens in both herds and, in herd 2, after IMI caused by major and minor pathogens. We also estimated the duration of increased SCC and DSCC when they exceeded a threshold, done separately for each pathogen group. Major pathogens had the longest-lasting effect in both herds for both SCC and DSCC. We conclude that the magnitude and duration of response of SCC and DSCC to IMI differs between herds and causative pathogens.
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http://dx.doi.org/10.3168/jds.2020-19378DOI Listing
March 2021

SARS-CoV-2 in Danish Mink Farms: Course of the Epidemic and a Descriptive Analysis of the Outbreaks in 2020.

Animals (Basel) 2021 Jan 12;11(1). Epub 2021 Jan 12.

Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, 1870 Frederiksberg C, Denmark.

SARS-CoV-2 infection is the cause of COVID-19 in humans. In April 2020, SARS-CoV-2 infection in farmed mink () occurred in the Netherlands. The first outbreaks in Denmark were detected in June 2020 in three farms. A steep increase in the number of infected farms occurred from September and onwards. Here, we describe prevalence data collected from 215 infected mink farms to characterize spread and impact of disease in infected farms. In one third of the farms, no clinical signs were observed. In farms with clinical signs, decreased feed intake, increased mortality and respiratory symptoms were most frequently observed, during a limited time period (median of 11 days). In 65% and 69% of farms, virus and sero-conversion, respectively, were detected in 100% of sampled animals at the first sampling. SARS-CoV-2 was detected, at low levels, in air samples collected close to the mink, on mink fur, on flies, on the foot of a seagull, and in gutter water, but not in feed. Some dogs and cats from infected farms tested positive for the virus. Chickens, rabbits, and horses sampled on a few farms, and wildlife sampled in the vicinity of the infected farms did not test positive for SARS-CoV-2. Thus, mink are highly susceptible to infection by SARS-CoV-2, but routes of transmission between farms, other than by direct human contact, are unclear.
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http://dx.doi.org/10.3390/ani11010164DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828158PMC
January 2021

Endogenous Fatty Acid Synthesis Drives Brown Adipose Tissue Involution.

Cell Rep 2021 Jan;34(2):108624

Department of Biochemistry and Molecular Cell Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

Thermoneutral conditions typical for standard human living environments result in brown adipose tissue (BAT) involution, characterized by decreased mitochondrial mass and increased lipid deposition. Low BAT activity is associated with poor metabolic health, and BAT reactivation may confer therapeutic potential. However, the molecular drivers of this BAT adaptive process in response to thermoneutrality remain enigmatic. Using metabolic and lipidomic approaches, we show that endogenous fatty acid synthesis, regulated by carbohydrate-response element-binding protein (ChREBP), is the central regulator of BAT involution. By transcriptional control of lipogenesis-related enzymes, ChREBP determines the abundance and composition of both storage and membrane lipids known to regulate organelle turnover and function. Notably, ChREBP deficiency and pharmacological inhibition of lipogenesis during thermoneutral adaptation preserved mitochondrial mass and thermogenic capacity of BAT independently of mitochondrial biogenesis. In conclusion, we establish lipogenesis as a potential therapeutic target to prevent loss of BAT thermogenic capacity as seen in adult humans.
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http://dx.doi.org/10.1016/j.celrep.2020.108624DOI Listing
January 2021

Insulin-Stimulated Muscle Glucose Uptake and Insulin Signaling in Lean and Obese Humans.

J Clin Endocrinol Metab 2021 Mar;106(4):e1631-e1646

Endocrine Research Unit, Mayo Clinic, Rochester, MN, USA.

Purpose: Skeletal muscle is the primary site for insulin-stimulated glucose disposal, and muscle insulin resistance is central to abnormal glucose metabolism in obesity. Whether muscle insulin signaling to the level of Akt/AS160 is intact in insulin-resistant obese humans is controversial.

Methods: We defined a linear range of insulin-stimulated systemic and leg glucose uptake in 14 obese and 14 nonobese volunteers using a 2-step insulin clamp (Protocol 1) and then examined the obesity-related defects in muscle insulin action in 16 nonobese and 25 obese male and female volunteers matched for fitness using a 1-step, hyperinsulinemic, euglycemic clamp coupled with muscle biopsies (Protocol 2).

Results: Insulin-stimulated glucose disposal (Si) was reduced by > 60% (P < 0.0001) in the obese group in Protocol 2; however, the phosphorylation of Akt and its downstream effector AS160 were not different between nonobese and obese groups. The increase in phosphorylation of Akt2 in response to insulin was positively correlated with Si for both the nonobese (r = 0.53, P = 0.03) and the obese (r = 0.55, P = 0.01) groups. Total muscle GLUT4 protein was 17% less (P < 0.05) in obese subjects.

Conclusions: We suggest that reduced muscle glucose uptake in obesity is not due to defects in the insulin signaling pathway at the level of Akt/AS160, which suggests there remain significant gaps in our knowledge of muscle insulin resistance in obesity. Our data imply that models of acute lipotoxicity do not replicate the pathophysiology of obesity.
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http://dx.doi.org/10.1210/clinem/dgaa919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993573PMC
March 2021

Can cheese mites, maggots and molds enhance bioactivity? Peptidomic investigation of functional peptides in four traditional cheeses.

Food Funct 2021 Jan 21;12(2):633-645. Epub 2020 Dec 21.

Department of Food Science and Technology, University of California at Davis, One Shields Avenue, Davis, California 95616, USA.

Aside from their amino acid content, dairy proteins are valuable for their ability to carry encrypted bioactive peptides whose activities are latent until released by digestive enzymes or endogenous enzymes within the food. Peptides can possess a wide variety of functionalities, such as antibacterial, antihypertensive, and antioxidative properties, as demonstrated by in vitro and in vivo studies. This phenomenon raises the question as to what impact various traditional cheese-making processes have on the formation of bioactive peptides in the resulting products. In this study, we have profiled the naturally-occurring peptides in two hard and two soft traditional cheeses and have identified their known bioactive sequences. While past studies have typically identified fewer than 100 peptide sequences in a single cheese, we have used modern instrumentation to identify between 2900 and 4700 sequences per cheese, an increase by a factor of about 50. We demonstrated substantial variations in proteolysis and peptide formation between the interior and rind of each cheese, which we ascribed to the differences in microbial composition between these regions. We identified a total of 111 bioactive sequences among the four cheeses, with the greatest number of sequences, 89, originating from Mimolette. The most common bioactivities identified were antimicrobial and inhibition of the angiotensin-converting enzyme. This work revealed that cheese proteolysis and the resulting peptidomes are more complex than originally thought in terms of the number of peptides released, variation in peptidome across sites within a single cheese, and variation in bioactive peptides among cheese-making techniques.
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http://dx.doi.org/10.1039/d0fo02439bDOI Listing
January 2021

Evaluation of Two Fecal Occult Blood Tests for Detecting Non-Perforating Abomasal Lesions in Cattle.

Animals (Basel) 2020 Dec 9;10(12). Epub 2020 Dec 9.

Department of Veterinary Clinical Sciences, University of Copenhagen, Højbakkegård Alle 5A, DK-2630 Taastrup, Denmark.

Non-perforating abomasal lesions occur with a high prevalence in slaughtered dairy cattle. Ante mortem diagnosis is a challenge, but the presence of occult blood in feces is suggested as a diagnostic criterion. The lower detection limit of Hemo-Fec (Med-Kjemi, Asker, Norway) and Hemoccult II SENSA (Beckman Coulter, Brea, California, USA) for fecal occult blood were estimated. The Hemo-Fec and Hemoccult II SENSA could detect 1-2 mL and 2-4.5 mL of blood in 1000 g of feces, respectively. Therefore, the Hemo-Fec test was selected to access hemoglobin degradation in the rumen to establish if blood from outside the gastrointestinal tract could result in false-positive tests and an observational study to estimate the diagnostic sensitivity and specificity. Rumen microbiota did not degrade hemoglobin in a 1% blood concentration in vitro during 48 h of fermentation. The Hemo-Fec test was only able to detect cattle with ≥4 acute lesions (diagnostic sensitivity: 0.40 [95% confidence interval (95% CI): 0.32-0.48] and ≥4 chronic lesions (sensitivity: 0.44 [95% CI: 0.35-0.52]). The Hemo-Fec test had no diagnostic potential to detect superficial erosions or scar tissue in abomasa. Furthermore, the specificity was 0.71 [95% CI: 0.68-0.75%], and a positive test is thus not equivalent with abomasal lesions in cattle.
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http://dx.doi.org/10.3390/ani10122356DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763188PMC
December 2020

Welfare of cattle during killing for purposes other than slaughter on-farm killing of cattle.

EFSA J 2020 Nov 28;18(11):e06312. Epub 2020 Nov 28.

Cattle of different ages may have to be killed on farm for purposes other than slaughter (the latter being defined as killing for human consumption) either individually or on a large scale, e.g. for economic reasons or for disease control. The purpose of this scientific opinion is to assess the risks associated with the on-farm killing of cattle. The processes during on-farm killing that were assessed included handling and moving, stunning and/or killing methods (including restraint). The killing methods were grouped into mechanical and electrical methods as well as lethal injection. In total, 21 hazards compromising animal welfare were identified and characterised, most of these related to stunning and/or killing. Staff was identified as an origin for all hazards, either due to lack of appropriate skills needed to perform tasks or due to fatigue. Possible preventive and corrective measures were assessed: measures to correct hazards were identified for 19 hazards, and the staff was shown to have a crucial role in prevention. Three welfare consequences of hazards to which cattle can be exposed during on-farm killing were identified: impeded movement, pain and fear. The welfare consequences and relevant animal-based measures related to these were described. Outcome tables linking hazards, welfare consequences, animal-based measures, origins of the hazards, preventive and corrective measures were developed for each process. Mitigation measures to minimise the welfare consequences are proposed.
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http://dx.doi.org/10.2903/j.efsa.2020.6312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696001PMC
November 2020

Tissue, urine and serum NMR metabolomics dataset from a 5/6 nephrectomy rat model of chronic kidney disease.

Data Brief 2020 Dec 23;33:106567. Epub 2020 Nov 23.

Department of Chemistry and Bioscience, Aalborg University, 9220 Aalborg, Denmark.

Serum, urine and tissue from a rat model of chronic kidney disease (CKD) were analysed using nuclear magnetic resonance (NMR) spectroscopy-based metabolomics methods, and compared with samples from sham operated rats. Both urine and serum were sampled at multiple timepoints, and the results have been reported elsewhere (https://doi.org/10.1007/s11306-019-1569-3[1]). The data could be useful to researchers working with human CKD or rat models of the disease. In addition, several different types of NMR spectra were recorded, including 1D NOESY, CPMG, and 2D J-resolved spectra, and the data could be useful for method comparison and algorithm development, both in terms of NMR spectroscopy and multivariate analysis.
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http://dx.doi.org/10.1016/j.dib.2020.106567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708935PMC
December 2020

Thermodynamics in Ecology-An Introductory Review.

Entropy (Basel) 2020 Jul 27;22(8). Epub 2020 Jul 27.

Department of General Chemistry, Environmental Chemistry Section, Pharmaceutical Faculty, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen Ø, Denmark.

How to predict the evolution of ecosystems is one of the numerous questions asked of ecologists by managers and politicians. To answer this we will need to give a scientific definition to concepts like sustainability, integrity, resilience and ecosystem health. This is not an easy task, as modern ecosystem theory exemplifies. Ecosystems show a high degree of complexity, based upon a high number of compartments, interactions and regulations. The last two decades have offered proposals for interpretation of ecosystems within a framework of thermodynamics. The entrance point of such an understanding of ecosystems was delivered more than 50 years ago through Schrödinger's and Prigogine's interpretations of living systems as "negentropy feeders" and "dissipative structures", respectively. Combining these views from the far from equilibrium thermodynamics to traditional classical thermodynamics, and ecology is obviously not going to happen without problems. There seems little reason to doubt that far from equilibrium systems, such as organisms or ecosystems, also have to obey fundamental physical principles such as mass conservation, first and second law of thermodynamics. Both have been applied in ecology since the 1950s and lately the concepts of exergy and entropy have been introduced. Exergy has recently been proposed, from several directions, as a useful indicator of the state, structure and function of the ecosystem. The proposals take two main directions, one concerned with the exergy stored in the ecosystem, the other with the exergy degraded and entropy formation. The implementation of exergy in ecology has often been explained as a translation of the Darwinian principle of "survival of the fittest" into thermodynamics. The fittest ecosystem, being the one able to use and store fluxes of energy and materials in the most efficient manner. The major problem in the transfer to ecology is that thermodynamic properties can only be calculated and not measured. Most of the supportive evidence comes from aquatic ecosystems. Results show that natural and culturally induced changes in the ecosystems, are accompanied by a variations in exergy. In brief, ecological succession is followed by an increase of exergy. This paper aims to describe the state-of-the-art in implementation of thermodynamics into ecology. This includes a brief outline of the history and the derivation of the thermodynamic functions used today. Examples of applications and results achieved up to now are given, and the importance to management laid out. Some suggestions for essential future research agendas of issues that needs resolution are given.
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http://dx.doi.org/10.3390/e22080820DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517404PMC
July 2020

Shared care follow-up of patients with B-cell neoplasms based on nurse-led telephone consultations and PRO-data: a feasibility study from the North Denmark Region.

BMC Health Serv Res 2020 Nov 17;20(1):1047. Epub 2020 Nov 17.

Department of Hematology, Aalborg University Hospital, Sdr. Skovvej 15, DK-9000, Aalborg, Denmark.

Background: Patients with B-cell neoplasms in remission are monitored with regular physician visits at the hospital. The current standard follow-up procedure is not evidence-based or individualized to patient needs. To improve and individualize the follow-up, we investigated the feasibility of a shared care follow-up initiative, with alternating physician visits and nurse-led telephone consultations and assessments based on patient-reported outcome (PRO) data.

Methods: Patients ≥18 years diagnosed with B-cell neoplasms were eligible for the study when they were in remission and stable without treatment for at least 6 months. Patients were assigned to alternating visits with physicians and nurse-led telephone consultations. The nurse-led telephone consultations were based on PROs, which were collected with the European Organization for Research and Treatment of Cancer questionnaire (EORTC-QLQ-C30), the Myeloproliferative Neoplasm - Symptom Assessment Form, and the Hospital Anxiety and Depression Scale. Patients completed questionnaires before every nurse-led consultation. We also applied the Patient Feedback Form to survey patient acceptance of the requirement of questionnaire completion. We applied descriptive statistics, in terms of counts (n) and proportions (%), to describe the study population and all endpoints.

Results: Between February 2017 and December 2018, 80 patients were enrolled. Adherence, measured as the recruitment rate, was 96% (80/83), and the drop-out rate was 6% (5/80). During the study period, 3/80 (4%) patients relapsed, and 5/80 (6%) patients returned to the standard follow-up, because they required closer medical observation. Relapses were diagnosed based on unscheduled visits requested by patients (n = 2) and patient-reported symptoms reviewed by the nurse (n = 1). The response rate to questionnaires was 98% (335/341). A total of 58/79 (74%) patients completed the Patient Feedback Form; 51/57 (89%) patients reported improved communication with health care professionals; and 50/57 (88%) patients reported improved recollection of symptoms as a result of completing questionnaires.

Conclusion: Based on patient adherence, a low relapse rate, and positive patient attitudes towards completing questionnaires, we concluded that a shared care follow-up, supported by PROs, was a feasible alternative to the standard follow-up for patients with B-cell disease in remission.
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http://dx.doi.org/10.1186/s12913-020-05899-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670769PMC
November 2020

Rift Valley Fever - assessment of effectiveness of surveillance and control measures in the EU.

EFSA J 2020 Nov 5;18(11):e06292. Epub 2020 Nov 5.

Effectiveness of surveillance and control measures against Rift Valley Fever (RVF) in Mayotte (overseas France) and in continental EU were assessed using mathematical models. Surveillance for early detection of RVF virus circulation implies very low design prevalence values and thus sampling a high number of animals, so feasibility issues may rise. Passive surveillance based on notified abortions in ruminants is key for early warning and at present the only feasible surveillance option. The assessment of vaccination and culling against RVF in Mayotte suggests that vaccination is more effective when quickly implemented throughout the population, e.g. at a rate of 200 or 2,000 animals vaccinated per day. Test and cull is not an option for RVF control in Mayotte given the high number of animals that would need to be tested. If the risk of RVFV introduction into the continental EU increases, ruminant establishments close to possible points of disease incursion should be included in the surveillance. An enhanced surveillance on reproductive disorders should be applied during summer in risk areas. Serosurveillance targets of 0.3% animals should be at least considered. RVF control measures possibly applied in the continental EU have been assessed in the Netherlands, as an example. Culling animals on farms within a 20 km radius of detected farms appears as the most effective measure to control RVF spread, although too many animals should be culled. Alternative measures are vaccination in a 50 km radius around detection, ring vaccination between 20 and 50 km and culling of detected farms. The assessment of zoning showed that, following RVFV introduction and considering an R = 2, a mean vector dispersal of 10 km and 10 farms initially detected, RVFV would spread beyond a radius of up to 100 km or 50 km from the infected area with 10% or 55% probability, respectively.
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http://dx.doi.org/10.2903/j.efsa.2020.6292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7642843PMC
November 2020

Welfare of cattle at slaughter.

EFSA J 2020 Nov 3;18(11):e06275. Epub 2020 Nov 3.

The killing of cattle for human consumption (slaughtering) can take place in a slaughterhouse or on farm. The processes of slaughtering that were assessed for welfare, from the arrival of cattle until their death (including slaughtering without stunning), were grouped into three main phases: pre-stunning (including arrival, unloading from the truck, lairage, handling and moving of cattle); stunning (including restraint); and bleeding. Stunning methods were grouped into two categories: mechanical and electrical. Twelve welfare consequences that cattle may be exposed to during slaughter were identified: heat stress, cold stress, fatigue, prolonged thirst, prolonged hunger, impeded movement, restriction of movements, resting problems (inability to rest or discomfort during resting), social stress, pain, fear and distress. Welfare consequences and their relevant animal-based measures are described. In total, 40 welfare hazards that could occur during slaughter were identified and characterised, most of them related to stunning and bleeding. Staff were identified as the origin of 39 hazards, which were attributed to the lack of appropriate skill sets needed to perform tasks or to fatigue. Measures to prevent and correct hazards were identified, and structural and managerial measures were identified as those with a crucial role in prevention. Outcome tables linking hazards, welfare consequences, animal-based measures, origin of hazards, and preventive and corrective measures were developed for each process. Mitigation measures to minimise welfare consequences are proposed.
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http://dx.doi.org/10.2903/j.efsa.2020.6275DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607414PMC
November 2020

Evaluation of existing guidelines for their adequacy for the microbial characterisation and environmental risk assessment of microorganisms obtained through synthetic biology.

EFSA J 2020 Oct 28;18(10):e06263. Epub 2020 Oct 28.

EFSA was asked by the European Commission to consider synthetic biology developments for agri-food use in the near future and to determine if the use of this technology is expected to constitute potential risks and hazards for the environment. Moreover, EFSA was requested to evaluate the adequacy of existing guidelines for risk assessment and if updated guidance is needed. The scope of this Opinion covers viable synthetic biology microorganisms (SynBioMs) expected to be deliberately released into the environment. The evaluation was based on: (i) horizon scanning of published information, (ii) gap analysis of existing guidelines covering the scope of this mandate, and (iii) future outlooks. A horizon scan showed that SynBioM applications could be ready for deliberate release into the environment of the EU in the next decade. However, extensively engineered SynBioMs are only expected in the wider future. For the microbial characterisation and the environmental risk assessment, the existing EFSA Guidances are useful as a basis. The extent to which existing Guidances can be used depends on the familiarity of the SynBioM with non-modified organisms. Among the recommendations for updated Guidance, the range of uses of products to be assessed covering all agri-food uses and taking into account all types of microorganisms, their relevant exposure routes and receiving environments. It is suggested that new EFSA Guidances address all 'specific areas of risk' as per Directive 2001/18/EC. No novel environmental hazards are expected for current and near future SynBioMs. However, the efficacy by which the SynBioMs interact with the environment may differ. This could lead to increased exposure and risk. Novel hazards connected with the development of xenobionts may be expected in the wider future.
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http://dx.doi.org/10.2903/j.efsa.2020.6263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592124PMC
October 2020

No effect of 10 weeks erythropoietin treatment on lipid oxidation in healthy men.

Endocr Connect 2020 Dec;9(12):1148-1155

Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.

Studies indicate that erythropoietin (EPO) has effect on lipid and energy metabolism; however, the impact of EPO on lipid oxidation in vivo has not been well documented. Here, we evaluate whether long-term erythropoiesis-stimulating agent (ESA) treatment affects the oxidation of plasma very low-density lipoprotein triglycerides (VLDL-TG) fatty acids (FA), plasma free fatty acids (FFA) and non-plasma (residual) FA in healthy, young, sedentary men. Infusion of [1-14C]VLDL-TG and [9,10-3H]palmitate was used in combination with indirect calorimetry to assess resting lipid fuel utilization and kinetics, and resting energy expenditure (REE) before and after 10 weeks of ESA exposure compared with placebo. REE increased significantly during ESA compared with placebo (P = 0.023, RM-ANOVA). Oxidation rates of VLDL-TG FA, FFA, and residual FA remained unchanged during ESA compared with placebo. The relative contribution of the lipid stores was greatest for FFA (47.1%) and the total lipid oxidation rate and was not significantly different between ESA and placebo-treated subjects. We conclude that long-term ESA treatment of healthy young men increases REE but does not alter the oxidation rates of plasma and non-plasma FA sources.
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http://dx.doi.org/10.1530/EC-20-0305DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7774772PMC
December 2020

Target-Mediated Brain Tissue Binding for Small Molecule Inhibitors of Heat Shock Protein 90.

Pharmaceutics 2020 Oct 22;12(11). Epub 2020 Oct 22.

Translational DMPK, H. Lundbeck A/S, 2500 Copenhagen-Valby, Denmark.

Drug distribution in the brain is generally associated with an affinity for fatty brain tissues and therefore known to be species- and concentration-independent. We report here the effect of target affinity on brain tissue binding for 10 small molecules designed to inhibit brain heat shock protein 90 (HSP90), a widespread protein whose expression is 1-2% of total cytosolic proteins in eucaryotes. Our results show that increasing the test item concentrations from 0.3 to 100 µM increased the unbound fraction 32-fold for the most potent molecules, with no change for the inactive one (1.1 fold change). Saturation of HSP90 led to normal concentration-independent brain tissue binding. In vivo pharmacokinetics performed in rats showed that the overall volume of distribution of compounds is correlated with their affinity for HSP90. The in vitro binding and in vivo pharmacokinetics (PK) performed in rats showed that small molecule HSP90 inhibitors followed the principle of target-mediated drug disposition. We demonstrate that assessing unbound fractions in brain homogenate was subject to HSP90 target interference; this may challenge the process of linking systemic-free drug concentrations to central nervous system unbound concentrations necessary to establish the proper pharmacokinetics/pharmacodynamics (PK/PD) relation needed for human dose prediction.
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http://dx.doi.org/10.3390/pharmaceutics12111009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690585PMC
October 2020

Calsyntenin 3β Is Dynamically Regulated by Temperature in Murine Brown Adipose and Marks Human Multilocular Fat.

Front Endocrinol (Lausanne) 2020 25;11:579785. Epub 2020 Sep 25.

Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Activation of thermogenic adipose tissue is linked to improved metabolic outcomes in mice and humans. Dissipation of energy as heat during thermogenesis relies on sufficient innervation of fat by sympathetic nerve fibers, a process recently proposed to be regulated by the adipose-specific calsyntenin3β (Clstn3β)-S100b axis. Here we aimed 1) to assess enrichment patterns of , as well as the previously annotated neuronal in perirenal brown and subcutaneous white human fat specimens, and 2) to investigate if the novel is dynamically regulated by changes in environmental temperatures and nutritional stress in thermogenic adipose tissues in mice. We provide evidence for enrichment in multilocular perirenal fat located anatomically in the proximity to both the adrenal gland and sympathetic nerve bundles innervating the kidney in humans. Moreover, transcript levels of , but not or , positively correlate with uncoupling protein 1 () expression in human adipose tissue. Our results further show that is preferentially expressed in brown adipocytes and is highly responsive to changes in environmental temperature and obesity state in mice. Collectively, this brief communication highlights as a hallmark of thermogenic adipose depots in mice and humans.
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http://dx.doi.org/10.3389/fendo.2020.579785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546853PMC
September 2020

Rift Valley Fever - epidemiological update and risk of introduction into Europe.

EFSA J 2020 Mar 6;18(3):e06041. Epub 2020 Mar 6.

Rift Valley fever (RVF) is a vector-borne disease transmitted by a broad spectrum of mosquito species, especially Aedes and Culex genus, to animals (domestic and wild ruminants and camels) and humans. Rift Valley fever is endemic in sub-Saharan Africa and in the Arabian Peninsula, with periodic epidemics characterised by 5-15 years of inter-epizootic periods. In the last two decades, RVF was notified in new African regions (e.g. Sahel), RVF epidemics occurred more frequently and low-level enzootic virus circulation has been demonstrated in livestock in various areas. Recent outbreaks in a French overseas department and some seropositive cases detected in Turkey, Tunisia and Libya raised the attention of the EU for a possible incursion into neighbouring countries. The movement of live animals is the most important pathway for RVF spread from the African endemic areas to North Africa and the Middle East. The movement of infected animals and infected vectors when shipped by flights, containers or road transport is considered as other plausible pathways of introduction into Europe. The overall risk of introduction of RVF into EU through the movement of infected animals is very low in all the EU regions and in all MSs (less than one epidemic every 500 years), given the strict EU animal import policy. The same level of risk of introduction in all the EU regions was estimated also considering the movement of infected vectors, with the highest level for Belgium, Greece, Malta, the Netherlands (one epidemic every 228-700 years), mainly linked to the number of connections by air and sea transports with African RVF infected countries. Although the EU territory does not seem to be directly exposed to an imminent risk of RVFV introduction, the risk of further spread into countries neighbouring the EU and the risks of possible introduction of infected vectors, suggest that EU authorities need to strengthen their surveillance and response capacities, as well as the collaboration with North African and Middle Eastern countries.
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http://dx.doi.org/10.2903/j.efsa.2020.6041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7527653PMC
March 2020

Clinical and Genetic Investigations of 109 Index Patients With Dilated Cardiomyopathy and 445 of Their Relatives.

Circ Heart Fail 2020 10 6;13(10):e006701. Epub 2020 Oct 6.

Department of Cardiology, Odense University Hospital, Denmark (T.M.H., S.K.N., J.E.M., J.M.).

Background: It was the aim to investigate the frequency and genetic basis of dilated cardiomyopathy (DCM) among relatives of index patients with unexplained heart failure at a tertiary referral center.

Methods: Clinical investigations were performed in 109 DCM index patients and 445 of their relatives. All index patients underwent genetic investigations of 76 disease-associated DCM genes. A family history of DCM occurred in 11% (n=12) while clinical investigations identified familial DCM in a total of 32% (n=35). One-fifth of all relatives (n=95) had DCM of whom 60% (n=57) had symptoms of heart failure at diagnosis, whereas 40% (n=38) were asymptomatic. Symptomatic relatives had a shorter event-free survival than asymptomatic DCM relatives (<0.001).

Results: Genetic investigations identified 43 pathogenic (n=27) or likely pathogenic (n=16) variants according to the American College of Medical Genetics and Genomics and the Association for Molecular Pathology criteria. Forty-four percent (n=48/109) of index patients carried a pathogenic/likely pathogenic variant of whom 36% (n=27/74) had sporadic DCM, whereas 60% (21/35) were familial cases. Thirteen of the pathogenic/likely pathogenic variants were also present in ≥7 affected individuals and thereby considered to be of sufficient high confidence for use in predictive genetic testing.

Conclusions: A family history of DCM identified only 34% (n=12/35) of hereditary DCM, whereas systematic clinical screening identified the remaining 66% (n=23) of DCM families. This emphasized the importance of clinical investigations to identify familial DCM. The high number of pathogenic/likely pathogenic variants identified in familial DCM provides a firm basis for offering genetic investigations in affected families. This should also be considered in sporadic cases since adequate family evaluation may not always be possible and the results of the genetic investigations may carry prognostic information with an impact on individual management.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006701DOI Listing
October 2020

Increased lipolysis after infusion of acylated ghrelin: a randomized, double-blinded placebo-controlled trial in hypopituitary patients.

Clin Endocrinol (Oxf) 2020 Dec 3;93(6):672-677. Epub 2020 Aug 3.

Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.

Context: Acylated ghrelin increases growth hormone (GH) and adrenocorticotrophic hormone (ACTH) secretion from the anterior pituitary gland. Additionally, it increases free fatty acid levels independently of GH and ACTH, but the impact of ghrelin on fatty acid turnover has not been determined. This study was designed to test whether acylated ghrelin directly increases the turnover rate of fatty acids.

Design: Eight hypopituitary patients on stable replacement with GH and hydrocortisone were included in a randomized, double-blinded, placebo-controlled crossover study including two study days: (a) infusion of acylated ghrelin and (b) infusion of saline. The study day comprised a basal period (t = 0-120 minutes) and a hyperinsulinaemic-euglycemic clamp period (t = 120-300 minutes). Whole-body lipolysis was estimated at t = 90-120 and t = 270-300 minutes with a palmitate isotope dilution technique.

Results: Infusion of acylated ghrelin resulted in 10 times increased total ghrelin area under the curve (AUC) levels in the basal period and 15 times increased AUC levels in the clamp period compared with saline infusion (P < .001). GH levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol levels increased by 15% after ghrelin compared to saline infusion in the basal period (P = .03). Palmitate turnover was increased by 43% in the basal period (difference: 77 (20) µmol/min, P = .01) and unchanged in the clamp period (difference 0.9 (17) µmol/min, P = 1.0) after ghrelin compared to saline infusion.

Conclusions: Our results support the hypothesis that pharmacological levels of acylated ghrelin directly activate lipolysis at the whole-body level.
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http://dx.doi.org/10.1111/cen.14290DOI Listing
December 2020

Differences and Similarities in the Peptide Profile of Preterm and Term Mother's Milk, and Preterm and Term Infant Gastric Samples.

Nutrients 2020 Sep 15;12(9). Epub 2020 Sep 15.

Nutrition Program, School of Biological and Population Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis, OR 97331, USA.

Our previous studies revealed that milk proteases begin to hydrolyze proteins in the mammary gland and that proteolytic digestion continues within the infant stomach. No research has measured how the release of milk peptides differs between the gastric aspirates of term and premature infants. This study examined the presence of milk peptides in milk and gastric samples from term and preterm infants using an Orbitrap Fusion Lumos mass spectrometer. Samples were collected from nine preterm-delivering and four term-delivering mother-infant pairs. Our study reveals an increased count and ion abundance of peptides and decreased peptide length from mother's milk to the infant stomach, confirming that additional break-down of the milk proteins occurred in both preterm and term infants' stomachs. Protein digestion occurred at a higher level in the gastric contents of term infants than in gastric contents of preterm infants. An amino acid cleavage site-based enzyme analysis suggested that the observed higher proteolysis in the term infants was due to higher pepsin/cathepsin D activity in the stomach. Additionally, there was a higher quantity of antimicrobial peptides in term infant gastric contents than in those of preterm infants, which could indicate that preterm infants benefit less from bioactive peptides in the gut.
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http://dx.doi.org/10.3390/nu12092825DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551100PMC
September 2020

Recessive Inheritance of a Rare Variant in the Nuclear Mitochondrial Gene for in Late-Onset Dilated Cardiomyopathy.

Circ Genom Precis Med 2020 10 16;13(5):560-562. Epub 2020 Sep 16.

Department of Cardiology (S.K.N., F.H., J.M.), Odense University Hospital, Denmark.

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http://dx.doi.org/10.1161/CIRCGEN.120.003086DOI Listing
October 2020

Welfare of pigs at slaughter.

EFSA J 2020 Jun 17;18(6):e06148. Epub 2020 Jun 17.

The killing of pigs for human consumption (slaughtering) can take place in a slaughterhouse or on farm. The processes of slaughtering that were assessed for welfare, from the arrival of pigs until their death, were grouped into three main phases: pre-stunning (including arrival, unloading from the truck, lairage, handling and moving of pigs); stunning (including restraint); and bleeding. Stunning methods were grouped into three categories: electrical, controlled atmosphere and mechanical. Twelve welfare consequences the pigs can be exposed to during slaughter were identified: heat stress, cold stress, fatigue, prolonged thirst, prolonged hunger, impeded movement, restriction of movements, resting problem, negative social behaviour, pain, fear and respiratory distress. Welfare consequences and relevant animal-based measures were described. In total, 30 welfare hazards that could occur during slaughter were identified and characterised, most of them related to stunning and bleeding. Staff were identified as the origin of 29 hazards, which were attributed to the lack of appropriate skill sets needed to perform tasks or to fatigue. Corrective and preventive measures for these hazards were assessed: measures to correct hazards were identified, and management was shown to have a crucial role in prevention. Outcome tables linking hazards, welfare consequences, animal-based measures, origins and preventive and corrective measures were developed for each process. Mitigation measures to minimise welfare consequences are proposed.
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http://dx.doi.org/10.2903/j.efsa.2020.6148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447914PMC
June 2020