59 research outputs found

    The inflammatory biomarker YKL-40 decreases stepwise after exercise stress test

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    BACKGROUND: Serum YKL-40 is an inflammatory biomarker associated with disease activity and mortality in diseases characterized by inflammation such as coronary artery disease (CAD). Exercise has a positive effect on CAD, possibly mediated by a decreased inflammatory activity. This study aimed to compare serial measurements of serum YKL-40 before and after exercise in patients with stable CAD versus controls. MATERIALS AND METHODS: Eleven patients with stable CAD verified by coronary angiography (>70% stenosis) and 11 patients with a computer tomography angiography with no stenosis or calcification (calcium score=0) (controls) performed a standard clinical maximal exercise test. Serum YKL-40 was measured before exercise, immediately after exercise, and every hour for 6 h. RESULTS: Cardiovascular risk factors were more prevalent among the CAD patients compared with the controls. CAD patients had higher serum concentration of YKL-40 at baseline compared with controls, median (interquartile range) 94 (52–151) versus 57 (45–79) μg/l. Serum YKL-40 decreased stepwise after exercise, with a median decrease of 16 (13–39) μg/l for the CAD patients and 13 (10–22) μg/l for the controls from baseline to the lowest value. Thereafter, values increased again toward baseline level. Time after exercise was a significant factor for decrease in serum YKL-40 (P<0.0001), but no difference in YKL-40 decrease over time could be demonstrated between the groups (P=0.12). CONCLUSION: Serum YKL-40 is elevated in patients with documented CAD compared with controls, and it decreases stepwise after exercise in both groups, indicating an anti-inflammatory effect of exercise independent of the presence of coronary atherosclerosis

    Benefit and risk assessment of breastmilk for infant health in Norway: Opinion of the Steering Committee of the Norwegian Scientific Committee for Food Safety

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    Source at https://vkm.no/english/riskassessments/allpublications/benefitandriskassessmentofbreastmilkforinfanthealthinnorway.4.27ef9ca915e07938c3b2a6df.html.Breastmilk covers all the nutritional needs of the infant the first months of life, with the exception of vitamin D. In addition, breastmilk has a number of protective properties. However, as humans are exposed to polluting chemicals through food, air, water and skin contact, breastmilk also contains contaminants. Taking the present-day levels of contaminants in Norwegian breastmilk and the long duration of breastfeeding (12 months) in Norway into account, the Norwegian Scientific Committee for Food Safety concludes that contaminants poses a low risk to Norwegian infants, and that the benefits of breastmilk to Norwegian infants clearly outweigh the risk presented by contaminants

    Genome editing in food and feed production – implications for risk assessment. Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment

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    The Norwegian Scientific Committee for Food and Environment (VKM) initiated this work to examine the extent to which organisms developed by genome-editing technologies pose new challenges in terms of risk assessment. This report considers whether the risk assessment guidance on genetically modified organisms, developed by the European Food Safety Authority (EFSA), can be applied to evaluate potential risks of organisms developed by genome editing. Background Gene technology has allowed for the transfer of genes between organisms and species, and thereby to design altered genotypes with novel traits, i.e. GMOs. A new paradigm started in the early 2000s with the development of genome-editing techniques. Unlike traditional genetic modification techniques resulting in insertion of foreign DNA fragments at random locations in the genome, the new genome-editing techniques additionally open for a few single nucleotide edits or short insertions/deletions at a targeted site in an organism’s genome. These new techniques can be applied to most types of organisms, including plants, animals and microorganisms of commercial interest. An important question is how the novel, genome-edited organisms should be evaluated with respect to risks to health and the environment. The European Court of Justice decided in 2018 to include genome-edited organisms in the GMO definition and hence in the regulatory system already in place. This implies that all products developed by genome-editing techniques must be risk-assessed within the existing regulatory framework for GMOs. The European and Norwegian regulatory frameworks regulate the production, import and placing on the market of food and feed containing, consisting of or produced from GMOs, as well as the release of GMOs into the environment. The assessment draws on guidance documents originally developed by EFSA for risk assessment of GMOs, which were drawn up mainly to address risks regarding insertion of transgenes. The new genome-editing techniques, however, provide a new continuum of organisms ranging from those only containing a minor genetic alteration to organisms containing insertion or deletion of larger genomic regions. Risk assessment of organisms developed by genome editing The present discourse on how new genome-editing techniques should be regulated lacks an analysis of whether risk assessment methodologies for GMOs are adequate for risk assessment of organisms developed through the use of the new genome-editing techniques. Therefore, this report describes the use of genome-editing techniques in food and feed production and discusses challenges in risk assessment with the regulatory framework. Specifically, this report poses the question as to whether the EFSA guidance documents are sufficient for evaluating risks to health and environment posed by genome-edited plants, animals and microorganisms. To address these questions, the report makes use of case examples relevant for Norway. These examples, intended for food and feed, include oilseed rape with a modified fatty acid profile, herbicide-tolerant and pest-resistant crops, sterile salmon, virus-resistant pigs and hornless cattle. The report considers all aspects of the stepwise approach as described in the EFSA guidance documents. Conclusions The inherent flexibility of the EFSA guidance makes it suitable to cover health and environmental risk assessments of a wide range of organisms with various traits and intended uses. Combined with the embedded case-by-case approach the guidance is applicable to genome-edited organisms. The evaluation of the guidance demonstrates that the parts of the health and environmental risk assessment concerned with novel traits (i.e. the phenotype of the organism) may be fully applied to all categories of genome-edited organisms. ............publishedVersio

    Genome editing in food and feed production – implications for risk assessment. Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment

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    The Norwegian Scientific Committee for Food and Environment (VKM) initiated this work to examine the extent to which organisms developed by genome-editing technologies pose new challenges in terms of risk assessment. This report considers whether the risk assessment guidance on genetically modified organisms, developed by the European Food Safety Authority (EFSA), can be applied to evaluate potential risks of organisms developed by genome editing. Background Gene technology has allowed for the transfer of genes between organisms and species, and thereby to design altered genotypes with novel traits, i.e. GMOs. A new paradigm started in the early 2000s with the development of genome-editing techniques. Unlike traditional genetic modification techniques resulting in insertion of foreign DNA fragments at random locations in the genome, the new genome-editing techniques additionally open for a few single nucleotide edits or short insertions/deletions at a targeted site in an organism’s genome. These new techniques can be applied to most types of organisms, including plants, animals and microorganisms of commercial interest. An important question is how the novel, genome-edited organisms should be evaluated with respect to risks to health and the environment. The European Court of Justice decided in 2018 to include genome-edited organisms in the GMO definition and hence in the regulatory system already in place. This implies that all products developed by genome-editing techniques must be risk-assessed within the existing regulatory framework for GMOs. The European and Norwegian regulatory frameworks regulate the production, import and placing on the market of food and feed containing, consisting of or produced from GMOs, as well as the release of GMOs into the environment. The assessment draws on guidance documents originally developed by EFSA for risk assessment of GMOs, which were drawn up mainly to address risks regarding insertion of transgenes. The new genome-editing techniques, however, provide a new continuum of organisms ranging from those only containing a minor genetic alteration to organisms containing insertion or deletion of larger genomic regions. Risk assessment of organisms developed by genome editing The present discourse on how new genome-editing techniques should be regulated lacks an analysis of whether risk assessment methodologies for GMOs are adequate for risk assessment of organisms developed through the use of the new genome-editing techniques. Therefore, this report describes the use of genome-editing techniques in food and feed production and discusses challenges in risk assessment with the regulatory framework. Specifically, this report poses the question as to whether the EFSA guidance documents are sufficient for evaluating risks to health and environment posed by genome-edited plants, animals and microorganisms. To address these questions, the report makes use of case examples relevant for Norway. These examples, intended for food and feed, include oilseed rape with a modified fatty acid profile, herbicide-tolerant and pest-resistant crops, sterile salmon, virus-resistant pigs and hornless cattle. The report considers all aspects of the stepwise approach as described in the EFSA guidance documents. Conclusions The inherent flexibility of the EFSA guidance makes it suitable to cover health and environmental risk assessments of a wide range of organisms with various traits and intended uses. Combined with the embedded case-by-case approach the guidance is applicable to genome-edited organisms. The evaluation of the guidance demonstrates that the parts of the health and environmental risk assessment concerned with novel traits (i.e. the phenotype of the organism) may be fully applied to all categories of genome-edited organisms. ............acceptedVersionpublishedVersio

    Genome editing in food and feed production – implications for risk assessment. Opinion of the Steering Committee of the Norwegian Scientific Committee for Food and Environment

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    Source at https://vkm.no/I denne rapporten vurderer Vitenskapskomiteen for mat og miljø (VKM) utfordringer knyttet til helse- og miljørisikovurdering av genomredigerte organismer til mat- og fôrproduksjon. VKM har gått gjennom veiledningen for risikovurdering av genmodifiserte organismer (GMO) som Den europeiske myndighet for næringsmiddeltrygghet (EFSA) har utviklet, og vurdert om veiledningen også kan brukes til å vurdere risiko ved organismer som er utviklet ved genomredigering. VKM har selv tatt initiativ til denne rapporten.The Norwegian Scientific Committee for Food and Environment (VKM) initiated this work to examine the extent to which organisms developed by genome-editing technologies pose new challenges in terms of risk assessment. This report considers whether the risk assessment guidance on genetically modified organisms, developed by the European Food Safety Authority (EFSA), can be applied to evaluate potential risks of organisms developed by genome editing
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