Clinical evaluation of CoolSeal - a new, safe, and fast vessel sealing device in total thyroidectomy.

Objective. CoolSeal is a new vessel sealing system for dissection and hemostasis during surgery. No clinical studies have investigated safety, advantages or disadvantages regarding the use of this device. The aim of the present study was to investigate the safety of CoolSeal and compare it with conventional ligation technique or LigaSure during the total thyroidectomy. We hypothesized that the use of CoolSeal would reduce the operating time and bleeding without complications increase. Study design represents a retrospective cohort study with a tertiary reference center setting. Methods. We analyzed total thyroidectomy data from January 2021 to June 2023. We recorded patients' characteristics, surgical information, and postoperative outcome. Results. We performed 221 total thyroidectomies in the study period. Analysis was restricted to 171 patients operated by only two surgeons. Hemostasis was secured by conventional ligation in 117 patients (68%), LigaSure in 34 patients (20%) and CoolSeal in 20 patients (12%). Median thyroid weight and bleeding were 67 g and 50 ml, respectively. Procedures using LigaSure or Cool-Seal were on larger glands (median 205 g) without increased bleeding (50 ml). Operating time was shortest with CoolSeal (96 min, p=0.003) compared with LigaSure (117 min) or conventional ligation (115 min). Bleeding was reduced with CoolSeal compared with LigaSure (45 vs. 100 ml, p=0.003). With CoolSeal, median hospitalization was one postoperative day, no patients required re-operation. There was no palsy of recurrent laryngeal nerves and no permanent hypoparathyroidism. Conclusion. In our first clinical experience, CoolSeal was safe and efficient for total thyroidectomy. With a small sample size, we saw a clinical benefit with reduced operating time without post-operative complications increase.

Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol.

Background: Faecal microbiota transplantation (FMT) is a highly effective treatment for Clostridioides difficile infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application. Objectives: We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility. Design: Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting. Methods: We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy. Results: The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 108 non-specified bacteria. Conclusion: The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube. Trial registration: Not applicable.

A protocol for production of encapsulated donor faeces for faecal microbiota transplantation We provide a detailed description of how to produce encapsulated donor faeces for faecal microbiota transplantation (FMT). FMT is a highly effective treatment for diseases where the intestinal microbiota is compromised, in particular Clostridioides difficile infection. Encapsulated application is patient-friendly and non-invasive, but protocols for the production of FMT capsules have not been published or are not reproducible. We here provide detailed guidance for standard-equipped hospital laboratories to enable capsule production under the current regulatory framework for substances of human origin in Europe. The dissemination of this protocol will increase patients' access to a life-saving therapy.

A serosurvey examining exposure to Borrelia burgdorferi sensu lato and tick-borne encephalitis virus in Danish blood donors, August 2022.

Objectives: Borrelia burgdorferi sensu lato (Bbsl) and tick-borne encephalitis virus (TBEV) are tick-borne pathogens. This study aimed to investigate the seroprevalence of these pathogens in Danish blood donors. Methods: A total of 1000 plasma samples equally distributed (n = 200) from all five Danish regions were analyzed. Commercially available enzyme-linked immunosorbent assays were used to screen the samples for immunoglobulin G antibodies against Bbsl and TBEV. The samples positive for antibodies against TBEV were further examined with a commercially available enzyme-linked immunosorbent assay and a Luminex-based TBEV suspension multiplex immunoassay for specific antibodies against non-structural protein 1 (NS1) antigen suggestive of previous infection. Results: A total of 62 samples tested positive for immunoglobulin G antibodies against Bbsl. A total of 40 samples were positive or borderline for antibodies against TBEV, indicating potential infection or vaccination. Of these, one had antibodies against NS1, indicating past infection. The seroprevalence of Bbsl was 6.2% (95% confidence interval 4.8-7.8), with equal seroprevalence in all five regions. The seroprevalence of TBEV was 0.1% (95% confidence interval 0.01-0.62%). Conclusions: The seroprevalence of Bbsl was similar throughout the country and corresponds well with previous studies. The seroprevalence of TBEV NS1 was low, which is in line with a low number of reported tick-borne encephalitis cases in Denmark. The NS1 positive sample was from the Capital Region, an endemic TBEV area.

Perceiving affordances and the problem of visually indiscernible kinds.

In this study, I defend the claim that we can perceptually experience what objects afford when we engage with objects belonging to natural or artificial categorical high-level kinds. Experiencing affordances perceptually positions us to act in specific ways. The main aim of this study was to argue that this view has explanatory advantages over alternative views. An increasingly popular view within the philosophy of perception, most famously defended by Susanna Siegel, claims that we sometimes visually experience natural and artificial objects as belonging to categorical high-level kinds. When visually experiencing a lemon, one does not only experience its low-level properties such as shape and color, sometimes one also experiences the object as a lemon. A challenge arises when attempting to explain what happens when one experiences an object that is experientially indistinguishable from another object, yet these objects belong to different high-level categorical kinds. For instance, if someone perceptually experiences a lemon as a lemon, her experience can be considered as accurately representing or presenting a lemon. However, if the subject perceptually experiences a lemon-shaped soap bar, which cannot be discriminated from a real lemon by sight alone, the experience is deemed inaccurate because there is no real lemon present. The problem is that such a judgment seems counterintuitive; unlike with hallucinations and illusions, there seems to be nothing wrong with how the object appears. Therefore, it is difficult to understand how the mistake could be a perceptual mistake. I will first present arguments supporting the claim that when we visually encounter objects such as lemons, we sometimes also perceive the affordances of these objects-what they provide or offer us. I will further argue that this perspective on affordances offers a more compelling explanation than other alternative accounts when it comes to our perception of visually indistinguishable objects that nonetheless belong to categorically distinct high-level kinds.

Microbiological and decomposition analysis of mass mink burial sites during the COVID-19 pandemic.

In 2020, Denmark buried approximately four million culled, farmed mink in mass graves treated with slaked lime due to widespread SARS-CoV-2 infections. After six months, environmental concerns prompted the exhumation of these cadavers. Our analysis encompassed visual inspections, soil pH measurements, and gas emission assessments of the grave environment. Additionally, we evaluated carcasses for decay status, cadaverine content, and the presence of various pathogens, including SARS-CoV-2 and mink coronavirus. Our findings revealed minimal microbial activity and limited carcass decomposition. Although viral RNA from SARS-CoV-2 and mink coronavirus, along with DNA from Aleutian mink disease virus, were detected, the absence of infectious SARS-CoV-2 in cell culture assays suggests slow natural degradation processes. This study provides critical insights for future considerations in managing mass burial scenarios during outbreaks of livestock-associated zoonotic pathogens.

Changes in the urinary metabolome accompanied alterations in body mass and composition in women with overweight - impact of high versus low protein breakfast.

INTRODUCTION: Understanding why subjects with overweight and with obesity vary in their response to dietary interventions is of major interest for developing personalized strategies for body mass regulation. OBJECTIVES: The aim of this study was to investigate the relationship between changes in the urine metabolome and body mass during a breakfast meal intervention. Furthermore, we aimed to elucidate if the baseline urine metabolome could predict the response to the two types of breakfast meals (high versus low protein) during the intervention. METHODS: A total of 75 young, women with overweight were randomly allocated to one of two intervention groups: (1) High-protein (HP) or (2) low-protein (LP) breakfast as part of their habitual diet during a 12-week intervention. Beside the breakfast meal, participants were instructed to eat their habitual diet and maintain their habitual physical activity level. Nuclear magnetic resonance-based metabolomics was conducted on urine samples collected at baseline (wk 0), mid-intervention (wk 6), and at endpoint (wk 12). At baseline and endpoint, body mass was measured and DXA was used to measure lean body mass and fat mass. RESULTS: The baseline urine metabolite profile showed a slightly higher correlation (R2 = 0.56) to body mass in comparison with lean body mass (R2 = 0.51) and fat mass (R2 = 0.53). Baseline 24-h urinary excretion of trigonelline (p = 0.04), N, N-dimethylglycine (p = 0.02), and trimethylamine (p = 0.03) were significantly higher in individuals who responded with a reduction in body mass to the HP breakfast. CONCLUSIONS: Differences in the urine metabolome were seen for women that obtained a body weight loss in the response to the HP breakfast intervention and women who did not obtain a body weight loss, indicating that the urine metabolome contains information about the metabolic phenotype that influences the responsiveness to dietary interventions.

Discharging older patients from hospital to homecare: conflicts in collaborative practices among nurses across sectors.

BACKGROUND: Collaboration is a key factor influencing the quality and safety in patients transition between sectors. However, specific collaborative practices may give rise to conflict between hospital nurses and community nurses. AIMS: To gain a deeper understanding of collaborative practices which have the potential to fuel tension in collaboration between hospital nurses and community nurses during discharge of older patients from hospital to homecare. METHODS: A meta-ethnography approach was used in this study and a systematic literature search was conducted in 2022. RESULTS: Five themes were identified in the analysis. These themes revealed how uncertainty, limited confidence in information and personal attitude in communication may fuel tension between hospital nurses and community nurses. Tensions arising from a negative loop emerged because of uncertainty, causing a growing rift between hospital nurses and community nurses, leaving them as opponents rather than collaborators. The authors suggest that policy makers and managers can break this loop by underpinning shared policies and awareness of common objectives.

Family Club Denmark: A Quasi-Randomized Study of a Volunteer-Based Intervention to Support Vulnerable Families.

Volunteer interventions play a vital role in supporting families by offering accessible and community-based resources outside the formal professional sector. This study examines the impact of the volunteer intervention known as Family Club Denmark (FCD) on the well-being of parents and children. FCD aims to provide families with positive experiences and support relationship building. The intervention, open to families from diverse social backgrounds, comprises volunteer-led family clubs where parents and children aged 2-12 years engage in activities and meals. We allocated 510 families (363 vulnerable families) to FCD or placed them on a waiting list based on a first-come, first-served principle. We conducted baseline, post-intervention, and follow-up assessments through questionnaires, observations, and interviews. On average, families participated in 5.8 sessions, with both families and volunteers reporting high satisfaction. When compared to control families, we find that vulnerable FCD parents feel more confident playing with their children (p = 0.04, [0.01; 0.40], d = 0.25), require less assistance in playing with their children (p = 0.01, [-0.34; -0.05], d = 0.33), and report that their children have a more challenging time forming friendships (p = 0.01, [-0.51; -0.09], d = 0.29). However, we did not find significant effects on mental health, parenting stress, self-efficacy, self-worth, family routines, or child well-being. We observed similar results for the full sample. The discovery that parents feel more confident playing with their children after participating in FCD highlights the vital role of volunteer-based interventions in enhancing parental engagement and fostering positive parent-child interactions. Trial registration: ClinicalTrials.gov NCT03657888 (registered 29 August 2018).

Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection.

BACKGROUND & AIMS: Clostridioides difficile infection (CDI) is associated with high mortality. Fecal microbiota transplantation (FMT) is an established treatment for recurrent CDI, but its use for first or second CDI remains experimental. We aimed to investigate the effectiveness of FMT for first or second CDI in a real-world clinical setting. METHODS: This multi-site Danish cohort study included patients with first or second CDI treated with FMT from June 2019 to February 2023. The primary outcome was cure of C. difficile-associated diarrhea (CDAD) 8 weeks after the last FMT treatment. Secondary outcomes included CDAD cure 1 and 8 weeks after the first FMT treatment and 90-day mortality following positive C. difficile test. RESULTS: We included 467 patients, with 187 (40%) having their first CDI. The median patient age was 73 years (interquartile range [IQR], 58-82 years). Notably, 167 (36%) had antibiotic-refractory CDI, 262 (56%) had severe CDI, and 89 (19%) suffered from fulminant CDI. Following the first FMT treatment, cure of CDAD was achieved in 353 patients (76%; 95% confidence interval [CI], 71%-79%) at week 1. At week 8, 255 patients (55%; 95% CI, 50%-59%) maintained sustained effect. In patients without initial effect, repeated FMT treatments led to an overall cure of CDAD in 367 patients (79%; 95% CI, 75%-82%). The 90-day mortality was 10% (95% CI, 8%-14%). CONCLUSION: Repeated FMT treatments demonstrate high effectiveness in managing patients with first or second CDI. Forwarding FMT in CDI treatment guidelines could improve patient survival. CLINICALTRIALS: gov, Number: NCT03712722.

Effects on Child Development and Parent-Child Interaction of the FACAM Intervention: A Randomized Controlled Study of an Interdisciplinary Intervention to Support Women in Vulnerable Positions through Pregnancy and Early Motherhood.

Health inequality can have a profound impact on a child's life. Maternal mental health challenges can hinder bonding, leading to impaired functioning and poorer child outcomes. To provide extra support for vulnerable pregnant women, the FACAM intervention offers the services of a health nurse or family therapist from pregnancy until the child starts school. This study examined the effects of FACAM intervention on pregnant women in vulnerable positions and their children until the child turned two years old. We randomly assigned 331 pregnant women to either FACAM intervention or care as usual and assessed them at baseline and when the infant was 3-6, 12-13.5, and 24 months old. The primary outcome was maternal sensitivity measured by Coding Interactive Behavior (CIB). Secondary outcomes included the parent-child relationship, child social-emotional development, child developmental progress, parent-child interaction, and child development. Our findings indicate that care-as-usual children were significantly more involved than FACAM children when the child was 4-6 months old (b = -0.25, [-0.42; -0.08] d = -0.42). However, we suspect this result is due to a biased dropout. We did not find any significant differences in any other outcomes. Therefore, the study suggests that the FACAM intervention is not superior to care as usual regarding child development and parent-child interaction outcomes.

Collecting pieces for the 'puzzle': Nurses' intraprofessional collaboration in the hospital-to-home transition of older patients.

BACKGROUND AND AIM: Communication is a key factor in intraprofessional collaboration between hospital nurses and homecare nurses in hospital-to-home transitions of older patients with complex care needs. Gaining knowledge of the nature of cross-sectoral communication is crucial for understanding how nurses collaborate to ensure a seamless patient trajectory. This study explores how cross-sectoral electronic health records communication influences collaboration between hospital nurses and homecare nurses when discharging older patients with complex care needs. METHOD: The study is based on qualitative group interviews with six hospital nurses and 14 homecare nurses working at different hospitals and municipalities across Denmark. Data were analysed using reflexive thematic analysis, as described by Braun and Clark. FINDINGS: The themes Collecting pieces for the 'puzzle': Losing the holistic picture of the patient; Working blindfolded: limited provision of and access to critical information; and Bypassing the 'invisible wall': dialogue supports cohesion illustrate the impact of organisational structures within electronic health records have on hospital nurses' and homecare nurses' intraprofessional collaboration across sectors. Challenges with predefined and word-limited elements in digital communication, and inadequate and limited access to significant medical information were identified. To compensate for the inadequacy of the electronic health records, direct contact and dialogue were emphasised as ways of fostering successful collaboration and overcoming the barriers created by electronic health records. CONCLUSION: Despite hospital nurses' and homecare nurses' desire to conduct holistic patient assessments, their ability to collaborate was hindered by failures in electronic health record communication resulting from restrictive organisational structures across sectors. Thus, it became necessary for hospital nurses and homecare nurses to bypass the electronic health record system and engage in dialogue to provide holistic care when discharging older patients with complex care needs. However, by hospital nurses and homecare nurses compensating for counter-productive organisational structures, problems brought about by the electronic health record system paradoxically remain invisible.

Hospital managers' perspectives on pregnancy policy and work adjustments: A cross-sectional study.

BACKGROUND: Risk assessment and work adjustment according to EU legislation may safeguard pregnant employees and their offspring. Knowledge on management perspectives in relation to implementation of protective measures is limited. OBJECTIVES: The primary aim was to describe Danish hospital managers' engagement in pregnancy policy and work adjustment for pregnant employees. The secondary aim was to investigate how managers' characteristics and the setting affect engagement and behaviour. METHODS: This was a cross-sectional study of survey data from 212 managers. Outcomes were within dimensions of health promotion, pregnancy policy, work adjustment, collaboration, manager support, and sick leave. Logistic and ordinal logistic regression models were applied to identify associations between background information and outcomes. RESULTS: Of the managers included, 84% arranged meetings and 76% conducted occupational risk assessment. Most managers (96%) engaged in dialogue with the employees before sick leave. Most managers felt competent in providing guidance for pregnant employees and 99% considered work adjustment important, mainly to safeguard mothers and children. The self-reported data showed positive associations between female managers and feeling competent to guide the employee. Further, management training was associated with meetings with pregnant employees. Seniority was associated with feeling competent to guide and dialogue. Midwifery support was associated with competence in guiding employees about risk factors. CONCLUSION: Work adjustment and risk assessment for pregnant employees are considered a priority by Danish hospital managers. Overall, managers feel competent guiding pregnant employees. However, managers experience midwifery support beneficial for the guidance of pregnant employees.

Intranasal Inoculation with Classical Swine Fever Virus Provided a More Consistent Experimental Disease Model Compared to Oral Inoculation.

The severity of disease resulting from classical swine fever virus (CSFV) infection is determined by several factors, including virus strain and host factors. The different outcomes of experimental studies in pigs with the same strain of CSFV emphasize the need to elucidate the influence of individual factors within experimental protocols. In this study, we investigated the outcome of disease after oral and intranasal inoculation with a moderately virulent CSFV strain in young pigs. To compare the two routes of inoculation, various infection parameters were examined during a period of two weeks. While all intranasally inoculated pigs (n = 5) were directly infected, this was only the case for two out of five pigs after oral inoculation. In addition, the intranasally inoculated pigs developed a more pronounced clinical disease and pathological lesions, as well as markedly more change in hematological and immunological parameters than the orally inoculated pigs. The wide variation among the orally inoculated pigs implied that statistical evaluation was markedly impaired, leaving this route of application less suitable for comparative studies on classical swine fever. Furthermore, our study provides additional details about the immunomodulatory effects of CSFV on the kinetics of CRP, TNF-α, and leukocyte sub-populations in pigs after infection with the CSFV strain Paderborn.

Influence of Second-Generation Oral Contraceptives on Muscle Recovery after Repeated Resistance Exercise in Trained Females.

PURPOSE: Oral contraceptives (OCs) are commonly used by female athletes, but their effects on skeletal muscle are still poorly understood. We investigated if physically trained females using second-generation OCs differed from nonusers of OCs in the recovery of muscle function and muscle damage markers after repeated resistance exercise sessions. METHODS: We recruited 20 trained second-generation OC users and 20 trained nonusers to perform three strenuous resistance exercise sessions. Before, and 3, 24, and 48 h after exercise, blood samples were collected, and participants were evaluated for muscle soreness, maximal isometric and isokinetic muscle strength, vertical jump height, Wingate power performance, leg press strength, and intermittent recovery capacity (yo-yo test). All participants were provided with an energy-macronutrient-balanced diet during the experimental period. RESULTS: After resistance exercise, maximal isometric and isokinetic muscle strength, rate of force development, vertical jump height, and Wingate peak and average power were reduced, whereas markers of muscle damage were increased in both groups (P < 0.05). OC users experienced a greater reduction in isokinetic strength 3, 24, and 48 h after exercise compared with nonusers of OCs (interaction: P < 0.05). No other interactions were observed. CONCLUSIONS: We demonstrate that measures of muscle strength recovery after three strenuous resistance exercise sessions are comparable between trained females using second-generation OCs and nonusers of OCs. However, group differences were observed for isolated dynamic (isokinetic) muscle strength, suggesting a marginal benefit of not using OCs when accelerated recovery is needed.

Infant Ustekinumab Clearance, Risk of Infection, and Development After Exposure During Pregnancy.

BACKGROUND: Evidence on ustekinumab safety in pregnancy is gradually expanding, but its clearance in the postnatal period is unknown. The aim of this study was to investigate ustekinumab concentrations in umbilical cord blood and rates of clearance after birth, as well as how these correlate with maternal drug concentrations, risk of infection, and developmental milestones during the first year of life. METHODS: Pregnant women with inflammatory bowel disease were prospectively recruited from 19 hospitals in Denmark and the Netherlands between 2018 and 2022. Infant infections leading to hospitalization/antibiotics and developmental milestones were assessed. Serum ustekinumab concentrations were measured at delivery and specific time points. Nonlinear regression analysis was applied to estimate clearance. RESULTS: In 78 live-born infants from 76 pregnancies, we observed a low risk of adverse pregnancy outcomes and normal developmental milestones. At birth, the median infant-mother ustekinumab ratio was 2.18 (95% confidence interval, 1.69-2.81). Mean time to infant clearance was 6.7 months (95% confidence interval, 6.1-7.3 months). One in 4 infants at 6 months had an extremely low median concentration of 0.015 µg/mL (range 0.005-0.12 µg/mL). No variation in median ustekinumab concentration was noted between infants with (2.8 [range 0.4-6.9] µg/mL) and without (3.1 [range 0.7-11.0] µg/mL) infections during the first year of life (P = .41). CONCLUSIONS: No adverse signals after intrauterine exposure to ustekinumab were observed with respect to pregnancy outcome, infections, or developmental milestones during the first year of life. Infant ustekinumab concentration was not associated with risk of infections. With the ustekinumab clearance profile, live attenuated vaccination from 6 months of age seems of low risk.

Low Energy Availability Followed by Optimal Energy Availability Does Not Benefit Performance in Trained Females.

PURPOSE: Short periods of reduced energy availability are commonly undertaken by athletes to decrease body mass, possibly improve the power-to-mass ratio, and enhance physical performance. Our primary aim was to investigate the impact of 10 d of low energy availability (LEA) followed by 2 d of optimal energy availability (OEA) on physical performance parameters in trained females. Second, physiological markers at the whole-body and molecular level related to performance were evaluated. METHODS: Thirty young trained eumenorrheic females were matched in pairs based on training history and randomized to a 10-d intervention period of LEA (25 kcal·fat-free mass (FFM) -1 ·d -1 ) or OEA (50 kcal·FFM -1 ·d -1 ) along with supervised exercise training. Before the intervention, participants underwent a 5-d run-in period with OEA + supervised exercise training. After the LEA intervention, 2 d of recovery with OEA was completed. Participants underwent muscle biopsies, blood sampling, physical performance tests, body composition measurements, and resting metabolic rate measurements. A linear mixed model was used with group and time as fixed effects and subject as random effects. RESULTS: Compared with OEA, LEA resulted in reduced body mass, muscle glycogen content, repeated sprint ability, 4-min time-trial performance, and rate of force development of the knee extensors (absolute values; P < 0.05). Two days of recovery restored 4-min time-trial performance and partly restored repeated sprint ability, but performance remained inferior to the OEA group. When the performance data were expressed relative to body mass, LEA did not enhance performance. CONCLUSIONS: Ten days of LEA resulted in impaired performance (absolute values), with concomitant reductions in muscle glycogen. Two days of recovery with OEA partially restored these impairments, although physical performance (absolute values) was still inferior to being in OEA. Our findings do not support the thesis that LEA giving rise to small reductions in body mass improves the power-to-mass ratio and thus increases physical performance.

Influence of menstrual cycle phase and oral contraceptive phase on exercise performance in endurance-trained females.

BACKGROUND: Limited data exists on the influence of menstrual cycle (MC) phase and oral contraceptive (OC) phase on physical performance in endurance-trained females due to poor control regarding MC verification and differentiation. We aimed to evaluate exercise performance and the respiratory response to exercise in three distinct phases of the MC and OC cycle in endurance-trained females. METHODS: Using a prospective cohort study design, we recruited trained females (Vo2max 52±4 mL O2/min/kg) who were either not using oral contraceptives (NOC) or using monophasic OCs. NOC were tested in the early and late follicular phase (FP) and the mid-luteal phase (LP). OC-users were tested in the withdrawal phase (WP) and two times in the active OC phase (OCP). The test battery included DXA scans, blood sampling, a submaximal bike test, a maximal isometric knee-extensor strength test, 4 and 20-second bike sprints, and a 6 min time trial on a bike. MC phases were verified by the use of ovulation kits and circulating sex hormone levels. RESULTS: After the exclusion of four NOCs due to inadequate sex hormone levels, 11 NOC and 13 OC users were included in the final analysis. 6 min time trial performance, sprint performance, and most submaximal exercise intensity variables did not differ between MC phases and OC cycle phases. However, in NOC, ventilation (L/min) during exercise at 30% of aerobic peak power was 7.6% lower in the late FP compared to the LP (P<0.05). In OC users, muscle strength was 3.9% higher in the early OCP compared to WP (P<0.05), whereas body mass was higher in the late OCP compared to WP (P<0.05). CONCLUSIONS: Collectively, our study suggests that MC phase and OCP influence exercise performance to a limited extent in endurance-trained females.

Workplace intervention among pregnant hospital employees - A protocol of a cluster randomized trial.

BACKGROUND: Sick leave during pregnancy is frequent and 36 % of Danish pregnant employees are on sick leave > 14 days. Health care professionals are considered a risk population. This intervention applies preventive sessions including the pregnant employee, her manager and a midwife in addition to usual practiceat Aarhus University Hospital, Denmark (AUH). It is hypothesised that pregnant employees who participate in preventive sessions will have less sick leave and report better wellbeing compared to the reference group. METHODS: All departments at AUHare cluster randomized. A total of 25 and 24 departments are allocated to the intervention and reference group, respectively. The intervention is protocolled with preventive sessions in addition to usual practice. The reference group receives usual practice. The primary outcome is mean number of days on sick leave during pregnancy. Secondary outcomes are wellbeing measured as physical and mental health, general work ability, work-life balance, manager support, and completed work adjustments during pregnancy. Data on sick leave will be collected from the hospital payment system and survey data will be collected at inclusion and follow-up. DISCUSSION: This study will contribute to limited experimental research aimed to reduce sickness leave during pregnancy. The overall strength is the study design with easy access to study participants within a large hospital. The main limitation of the study is the high complexity of the study. TRIAL REGISTRATION: The trial is registered in ClinicalTrials.gov with ID number 29-2019-03.

Acute changes in the metabolome following resistance exercise combined with intake of different protein sources (cricket, pea, whey).

INTRODUCTION: Separately, both exercise and protein ingestion have been shown to alter the blood and urine metabolome. This study goes a step further and examines changes in the metabolome derived from blood, urine and muscle tissue extracts in response to resistance exercise combined with ingestion of three different protein sources. METHODS: In an acute parallel study, 52 young males performed one-legged resistance exercise (leg extension, 4 × 10 repetitions at 10 repetition maximum) followed by ingestion of either cricket (insect), pea or whey protein (0.25 g protein/kg fat free mass). Blood and muscle tissue were collected at baseline and three hours after protein ingestion. Urine was collected at baseline and four hours after protein ingestion. Mixed-effects analyses were applied to examine the effect of the time (baseline vs. post), protein (cricket, pea, whey), and time x protein interaction. RESULTS: Nuclear magnetic resonance (NMR)-based metabolomics resulted in the annotation and quantification of 25 metabolites in blood, 35 in urine and 21 in muscle tissue. Changes in the muscle metabolome after combined exercise and protein intake indicated effects related to the protein source ingested. Muscle concentrations of leucine, methionine, glutamate and myo-inositol were higher after intake of whey protein compared to both cricket and pea protein. The blood metabolome revealed changes in a more ketogenic direction three hours after exercise reflecting that the trial was conducted after overnight fasting. Urinary concentration of trimethylamine N-oxide was significantly higher after ingestion of cricket than pea and whey protein. CONCLUSION: The blood, urine and muscle metabolome showed different and supplementary responses to exercise and ingestion of the different protein sources, and in synergy the summarized results provided a more complete picture of the metabolic state of the body.

Effect of menstrual cycle and contraceptive pill phase on aspects of exercise physiology and athletic performance in female athletes: protocol for the Feminae international multisite innovative project.

The idiom 'more high-quality research is needed' has become the slogan for sport and exercise physiology-based research in female athletes. However, in most instances, it is challenging to address this gap of high-quality research in elite female athletes at a single study site due to challenges in recruiting enough participants with numerous menstrual cycle and contraceptive pill permutations. Accordingly, we have assembled an international multisite team to undertake an innovative project for female athletes, which investigates the effects of changes in endogenous and exogenous oestrogen and progesterone/progestins across the menstrual cycle and in response to second-generation combined monophasic contraceptive pill use, on aspects of exercise physiology and athletic performance. This project will employ the current gold-standard methodologies in this area, resulting in an adequately powered dataset. This protocol paper describes the consortium-based approach we will undertake during this study.