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[...]of writing, it is unclear whether this will result in a permanent change in how blood sampling for clinical trials and routine healthcare are performed, although it seems unlikely that the progression of these sampling technologies will be slowed by the current situation. Many of the early publications in this area had a primary focus on the development of blood sampling technologies, validation of bioanalytical methods and were limited to applications supporting nonclinical and clinical studies for pharmaceutical drug development. Bioanalysis 7(16) (2015). https://www.future-science.com/toc/bio/7/16 Neil Spooner: Spooner Bioanalytical Solutions Ltd, Hertford, UK and School of Life and Medical Sciences, University of Hertfordshire, UK Melanie Anderson: Merck and Co., Inc., West Point, PA 19486, USA Enaksha R Wickremsinhe: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA

Interventions to manage disease in wild animals are challenging, being characterised by sparse information on the distribution of infection and a limited ability to target infected individuals. In parts of Europe, the persistence of bovine tuberculosis (bTB caused by Mycobacterium bovis) in cattle is linked to reservoirs of infection in wild populations of European badgers (Meles meles). In this study, we describe the development of a method for the safe restraint and blood sampling of badgers in the field without recourse to anaesthesia. The approach utilises a specially designed cage to physically restrain badgers and a protocol for obtaining a blood sample from the metatarsal pad. In field trials, blood samples were successfully obtained on 30 of 33 occasions, and all samples produced a valid trap-side result using a rapid serological test. Same day examination of restrained animals detected no injuries other than the blood sampling incision site, and there was no evidence of a negative effect of restraint on subsequent recapture probability. The approach negates the need for field anaesthesia to obtain a diagnostic sample, thus eliminating the risks of associated adverse effects, reducing costs and time before release back into the wild. These advantages could expand current options for surveillance and disease control interventions in badgers by permitting more efficient trap-side sampling and testing.

Sustainability in human development sets exact standards for the management of natural resources, including their extraction, use, and the introduction of waste products into a complex, inventive circuit as a consequence of exploitation. Because of the negative influence that medical waste has on the environment and people, it needs specific handling. Medical waste is increasing in amount all the time and has a wide range of consequences across a wide range of activity domains. This paper discusses various issues of the sustainable management of blood sample bio-medical waste and evaluates the properties of alternative samples which are made of gelatin-coated sample paper. A unique bar-coded paper-based blood sample method has prevented complications during blood tests and is much more environmentally friendly.

We are aware of no study examining the effects of probiotic supplementation on symptoms of depression, metabolic profiles, serum high-sensitivity C-reactive protein (hs-CRP), and biomarkers of oxidative stress in patients with major depressive disorder (MDD). The present study was designed to determine the effects of probiotic intake on symptoms of depression and metabolic status in patients with MDD. This randomized, double-blind, placebo-controlled clinical trial included 40 patients with a diagnosis of MDD based on DSM-IV criteria whose age ranged between 20 and 55 y. Patients were randomly allocated into two groups to receive either probiotic supplements (n = 20) or placebo (n = 20) for 8 wk. Probiotic capsule consisted of three viable and freeze-dried strains: Lactobacillus acidophilus (2 × 109 CFU/g), Lactobacillus casei (2 × 109 CFU/g), and Bifidobacterium bifidum (2 × 109 CFU/g). Fasting blood samples were taken at the beginning and end of the trial to quantify the relevant variables. All participants provided three dietary records (two weekdays and one weekend) and three physical activity records during the intervention. Dietary intake of study participants was not significantly different between the two groups. After 8 wk of intervention, patients who received probiotic supplements had significantly decreased Beck Depression Inventory total scores (−5.7 ± 6.4 vs. −1.5 ± 4.8, P = 0.001) compared with the placebo. In addition, significant decreases in serum insulin levels (−2.3 ± 4.1 vs. 2.6 ± 9.3 μIU/mL, P = 0.03), homeostasis model assessment of insulin resistance (−0.6 ± 1.2 vs. 0.6 ± 2.1, P = 0.03), and serum hs-CRP concentrations (−1138.7 ± 2274.9 vs. 188.4 ± 1455.5 ng/mL, P = 0.03) were observed after the probiotic supplementation compared with the placebo. Additionally, taking probiotics resulted in a significant rise in plasma total glutathione levels (1.8 ± 83.1 vs. −106.8 ± 190.7 μmol/L, P = 0.02) compared with the placebo. We did not find any significant change in fasting plasma glucose, homeostatic model assessment of beta cell function, quantitative insulin sensitivity check index, lipid profiles, and total antioxidant capacity levels. Probiotic administration in patients with MDD for 8 wk had beneficial effects on Beck Depression Inventory, insulin, homeostasis model assessment of insulin resistance, hs-CRP concentrations, and glutathione concentrations, but did not influence fasting plasma glucose, homeostatic model assessment of beta cell function, quantitative insulin sensitivity check index, lipid profiles, and total antioxidant capacity levels. •We evaluated the effects of probiotic administration on clinical and metabolic responses in patients with major depressive disorder.•Probiotic supplementation in patients with major depressive disorder had beneficial effects on Beck Depression Inventory total score.•Probiotic supplementation in patients with major depressive disorder had beneficial effects on markers of insulin metabolism.

Purpose Population pharmacokinetic (PK) data collected from routine clinical practice offers a rich source of valuable information. However, in observational population PK data, accurate time information for blood samples is often missing, resulting in measurement errors (ME) in the sampling time variable. The goal of this study was to investigate the effects on model parameters when a scheduled time is used instead of the actual blood sampling time, and to propose ME correction methods. Methods Simulation studies were conducted based on two major factors: the curvature in PK profiles and the size of ME. As ME correction methods, transform both sides (TBS) models were developed with application of Box-Cox power transformation and Taylor expansion. The TBS models were compared to a conventional population PK model using simulations. Results The most important determinant of bias due to time ME was the degree of curvature (nonlinearity) in PK profiles; the smaller the curvature around sampling times, the smaller the associated bias. The second important determinant was the magnitude of ME; the larger the ME, the larger the bias. The proposed TBS models performed better than a conventional population PK modeling when curvature and ME were substantial. Conclusions Time ME in sampling time can lead to bias on the parameter estimators. The following practical recommendations are provided: 1) when the curvature of PK profiles is small, conventional population PK modeling is robust to even large ME; and 2) when the curvature is moderate or large, the proposed methodology reduces bias in parameter estimates.

Conventional skin and blood sampling techniques for disease diagnosis, though effective, are often highly invasive and some even suffer from variations in analysis. With the improvements in molecular detection, the amount of starting sample quantity needed has significantly reduced in some diagnostic procedures, and this has led to an increased interest in microsampling techniques for disease biomarker detection. The miniaturization of sampling platforms driven by microsampling has the potential to shift disease diagnosis and monitoring closer to the point of care. The faster turnaround time for actionable results has improved patient care. The variations in sample quantification and analysis remain a challenge in the microsampling field. The future of microsampling looks promising. Emerging techniques are being clinically tested and monitored by regulatory bodies. This process is leading to safer and more reliable diagnostic platforms. This review discusses the advantages and disadvantages of current skin and blood microsampling techniques.

The polyphenol quercetin may prevent CVD due to its antihypertensive and vasorelaxant properties. We investigated the effects of quercetin after regular intake on blood pressure (BP) in overweight-to-obese patients with pre-hypertension and stage I hypertension. In addition, the potential mechanisms responsible for the hypothesised effect of quercetin on BP were explored. Subjects (n 70) were randomised to receive 162 mg/d quercetin from onion skin extract powder or placebo in a double-blinded, placebo-controlled cross-over trial with 6-week treatment periods separated by a 6-week washout period. Before and after the intervention, ambulatory blood pressure (ABP) and office BP were measured; urine and blood samples were collected; and endothelial function was measured by EndoPAT technology. In the total group, quercetin did not significantly affect 24 h ABP parameters and office BP. In the subgroup of hypertensives, quercetin decreased 24 h systolic BP by −3·6 mmHg (P=0·022) when compared with placebo (mean treatment difference, −3·9 mmHg; P=0·049). In addition, quercetin significantly decreased day-time and night-time systolic BP in hypertensives, but without a significant effect in inter-group comparison. In the total group and also in the subgroup of hypertensives, vasoactive biomarkers including endothelin-1, soluble endothelial-derived adhesion molecules, asymmetric dimethylarginine, angiotensin-converting enzyme activity, endothelial function, parameters of oxidation, inflammation, lipid and glucose metabolism were not affected by quercetin. In conclusion, supplementation with 162 mg/d quercetin from onion skin extract lowers ABP in patients with hypertension, suggesting a cardioprotective effect of quercetin. The mechanisms responsible for the BP-lowering effect remain unclear.

We determined the effects of time-restricted feeding (TRF; 8 h/d) versus extended feeding (EXF; 15 h/d) on 24-h and postprandial metabolism and subjective opinions of TRF in men with overweight/obesity. In a randomized crossover design, 11 sedentary males (age 38 ± 5 y; BMI: 32.2 ± 2.0 kg/m2) completed two isoenergetic diet protocols for 5 days, consuming meals at 1000, 1300 and 1700 h (TRF) or 0700, 1400 and 2100 h (EXF). On Day 5, participants remained in the laboratory for 24 h, and blood samples were collected at hourly (0700–2300 h) then 2-hourly (2300–0700 h) intervals for concentrations of glucose, insulin and appetite/incretin hormones. Structured qualitative interviews were conducted following completion of both dietary conditions and investigated thematically. Total 24-h area under the curve (AUCtotal) [glucose] tended to be lower for TRF versus EXF (−5.5 ± 9.0 mmol/L/h, p = 0.09). Nocturnal glucose AUC was lower in TRF (−4.2 ± 5.8 mmol/L/h, p = 0.04), with no difference in waking glucose AUC or AUCtotal for [insulin]. Attitudes towards TRF were positive with improved feelings of well-being. Barriers to TRF were work schedules, family commitments and social events. Compared to extended feeding, short-term TRF improved nocturnal glycemic control and was positively perceived in men with overweight/obesity.

Oxidative stress plays a major role in the pathogenesis and progression of diabetes. Among various functional foods with an antioxidant effect, probiotic foods have been reported to repress oxidative stress. The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients. Sixty-four patients with type 2 diabetes mellitus, 30 to 60 y old, were assigned to two groups in this randomized, double-blind, controlled clinical trial. The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk. Fasting blood samples, 24-h dietary recalls, and anthropometric measurements were collected at the baseline and at the end of the trial. Probiotic yogurt significantly decreased fasting blood glucose (P < 0.01) and hemoglobin A1c (P < 0.05) and increased erythrocyte superoxide dismutase and glutathione peroxidase activities and total antioxidant status (P < 0.05) compared with the control group. In addition, the serum malondialdehyde concentration significantly decreased compared with the baseline value in both groups (P < 0.05). No significant changes from baseline were shown in insulin concentration and erythrocyte catalase activity within either group (P > 0.05). The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients. These results suggest that probiotic yogurt is a promising agent for diabetes management.

Dried blood spots (DBS) are being considered as an alternative sampling method of blood collection that can be used in combination with lipidomic and other omic analysis. DBS are successfully used in the clinical context to collect samples for newborn screening for the measurement of specific fatty acid derivatives, such as acylcarnitines, and lipids from whole blood for diagnostic purposes. However, DBS are scarcely used for lipidomic analysis and investigations. Lipidomic studies using DBS are starting to emerge as a powerful method for sampling and storage in clinical lipidomic analysis, but the major research work is being done in the pre- and analytical steps and procedures, and few in clinical applications. This review presents a description of the impact factors and variables that can affect DBS lipidomic analysis, such as the type of DBS card, haematocrit, homogeneity of the blood drop, matrix/chromatographic effects, and the chemical and physical properties of the analyte. Additionally, a brief overview of lipidomic studies using DBS to unveil their application in clinical scenarios is also presented, considering the studies of method development and validation and, to a less extent, for clinical diagnosis using clinical lipidomics. DBS combined with lipidomic approaches proved to be as effective as whole blood samples, achieving high levels of sensitivity and specificity during MS and MS/MS analysis, which could be a useful tool for biomarker identification. Lipidomic profiling using MS/MS platforms enables significant insights into physiological changes, which could be useful in precision medicine.