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Background: Evidence on the health benefits of spending time in nature has highlighted the importance of provision of blue and green spaces where people live. The potential for health benefits offered by nature exposure, however, extends beyond health promotion to health treatment. Social prescribing links people with health or social care needs to community-based, non-clinical health and social care interventions to improve health and wellbeing. Nature-based social prescribing (NBSP) is a variant that uses the health-promoting benefits of activities carried out in natural environments, such as gardening and walking. Much current NBSP practice has been developed in the UK, and there is increasing global interest in its implementation. This requires interventions to be adapted for different contexts, considering the needs of populations and the structure of healthcare systems. Methods: This paper presents results from an expert group participatory workshop involving 29 practitioners, researchers, and policymakers from the UK and Germany’s health and environmental sectors. Using the UK and Germany, two countries with different healthcare systems and in different developmental stages of NBSP practice, as case studies, we analysed opportunities, challenges, and facilitators for the development and implementation of NBSP. Results: We identified five overarching themes for developing, implementing, and evaluating NBSP: Capacity Building; Accessibility and Acceptability; Networks and Collaborations; Standardised Implementation and Evaluation; and Sustainability. We also discuss key strengths, weaknesses, opportunities, and threats for each overarching theme to understand how they could be developed to support NBSP implementation. Conclusions: NBSP could offer significant public health benefits using available blue and green spaces. We offer guidance on how NBSP implementation, from wider policy support to the design and evaluation of individual programmes, could be adapted to different contexts. This research could help inform the development and evaluation of NBSP programmes to support planetary health from local and global scales.

Abstract Background Research on intermittent fasting has shown that it can improve a variety of health outcomes, including blood sugar control, blood lipid levels and blood pressure. Only few studies document longer periods of fasting, especially in rehabilitation participants. Cardiac inpatient rehabilitation follows a multidisciplinary approach including change of health behaviour to reduce patients’ risk of future cardiovascular events. To date, evidence suggests that intermittent fasting can be an effective way to improve health and well-being, but more research is needed to fully understand its long-term effects and factors that promote the implementation. Therefore, the aim of the ongoing InterVFast trial is to investigate the effectiveness of intermittent fasting amongst cardiac rehabilitation patients after 4-week inpatient rehabilitation as well as 3 and 12 months subsequently including patients’ perspective. Methods This single-centre randomized controlled trial evaluates the effectiveness of the InterVFast intervention in weight loss (primary outcome). We also examine patients’ acceptance and the effect on relevant outcomes as blood glucose and triglyceride levels, cholesterol and high-sensitivity C-reactive protein. Weight, blood samples and clinical data are collected as part of the initial and final examination during inpatient rehabilitation. During inpatient rehabilitation, participants daily note fasting intervals and meals eaten as well as practicability in a fasting diary. In addition, interviews about perceived advantages and disadvantages and acceptance are carried out with the participants in the IG. A standardized follow-up examination (weight, blood samples) will be carried out by the family doctor after 3 and 12 months (t2 and t3). Discussion Compared to other weight-loss intervention studies, our study addresses patients with coronary heart disease and includes patients’ acceptance as well as long-term maintenance. It is hypothesized that participation in the InterVfast intervention will improve relevant health outcomes in a sample of cardiac rehabilitation patients and thus constitute a behavioural prevention strategy to reduce the risk of future cardiac events and improve overall health and quality of life. Trial registration ClinicalTrials.gov DRKS00023983. Registered on February 17, 2022.

IntroductionAyurveda, South Asia’s largest and most relevant system of Traditional Medicine, holds a legal status akin to conventional Western medicine in India and elsewhere. There is an almost complete lack of data on the use of Ayurveda in Germany. The aim of this study was to investigate Ayurveda’s utilization patterns, entry points, and factors influencing its use and the perception of Ayurveda among the German population.MethodsBasis of this manuscript was an online-representative survey which involved 4,065 participants aged 18–75 about the use and acceptance of Traditional, Complementary and Integrative Medicine (TCIM) in Germany. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022. The dataset was analyzed descriptively and inferentially.ResultsAltogether 9.3% (n = 377) of all survey participants (n = 4,065) had already used Ayurveda somehow, either more often (1.7%) or at least once in a lifetime (7.6%). Responders associated Ayurveda primarily with Indian Medicine (27.7%) and wellness (18%). Commonly used Ayurvedic services included non-medical treatments at wellness resorts/spas (48.3%), in outpatient practices (27.1%), and hotels (23.6%). 30.2% of the participants believe in Ayurveda’s therapeutic potential. 76.7% of Ayurveda users find healthy nutrition important or very important. Nine predictors were found to classify Ayurveda users vs. non-users with spirituality and belief in Ayurveda’s therapeutic efficacy as the most relevant ones. Ayurveda seems to be primarily used by well-educated and female individuals, often from higher-income groups and with a rather modern social milieu-orientation.ConclusionStudy results suggest that about every tenth German citizen has used Ayurveda in the past and about one third believes in its therapeutic potential. Because Ayurvedic therapies are often not evidence-based, there is an urgent need to perform high quality randomized controlled trials to investigate potential effects and safety of Ayurveda and how evidence-based Ayurveda treatments can be integrated into the German healthcare system.

BackgroundOlder representative surveys show that Traditional, Complementary and Integrative Medicine (TCIM) is used by about 60% of the German population. However, no data exists for the current nationwide situation. The main aim of this cross-sectional study is to investigate the current use and acceptance of TCIM in Germany.MethodsThis study is based on a representative sample of the German population aged 18–75 years. Participants were asked about the use and acceptance of TCIM. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022 by three renowned German market research institutes on behalf of and in close coordination with the working group. The data set was analyzed descriptively and inferentially.ResultsIn total, 4,065 participants (52% female, 48% male, 0.4% diverse) responded completely (response rate: 21.5%). Among participants, 70% stated that they had used TCIM at some point in their lives, with 32% doing so in the last 12 months and 18% currently. The most common reason given (17%) was musculoskeletal pain. For their own health, 39% stated that TCIM is important. Traditional European Medicine was rated as very/mainly effective by 27% of participants and as partly effective by 44% (conventional medicine: 69% very/mainly effective, 19% partly effective). As a complementary treatment strategy to conventional medicine, 35% considered TCIM to be optimal (“Complementary Medicine”), 33% in combination with conventional medicine (“Integrative Medicine”) and 5% without conventional medicine (“Alternative Medicine”). The majority of the participants were in favor of more research on TCIM and stated that the costs of TCIM services should be covered by health insurance companies (71% and 69%, respectively).ConclusionThese results from a representative online-population suggest that the use of TCIM in Germany remains at a high level. The nationwide relevance of TCIM should be given greater consideration in German health care policy making. TCIM should be systematically investigated using appropriate study designs and methods including high quality randomized clinical trials to investigate their effectiveness, efficacy, therapeutic safety and costs in the future.

Ultra-high performance liquid chromatography-high-resolution mass spectrometry (UPHLC-HRMS) is used to discover and monitor single or sets of biomarkers informing about metabolic processes of interest. The technique can detect 1000s of molecules (i.e., metabolites) in a single instrument run and provide a measurement of the global metabolome, which could be a fingerprint of activity. Despite the power of this approach, technical challenges have hindered the effective use of metabolomics to interrogate microbial communities implicated in the removal of priority contaminants. Herein, our efforts to circumvent these challenges and apply this emerging systems biology technique to microbiomes relevant for contaminant biodegradation will be discussed. Chlorinated ethenes impact many contaminated sites, and detoxification can be achieved by organohalide-respiring bacteria, a process currently assessed by quantitative gene-centric tools (e.g., quantitative PCR). This laboratory study monitored the metabolome of the SDC-9™ bioaugmentation consortium during cis-1,2-dichloroethene (cDCE) conversion to vinyl chloride (VC) and nontoxic ethene. Untargeted metabolomics using an UHPLC-Orbitrap mass spectrometer and performed on SDC-9™ cultures at different stages of the reductive dechlorination process detected ~10,000 spectral features per sample arising from water-soluble molecules with both known and unknown structures. Multivariate statistical techniques including partial least squares-discriminate analysis (PLSDA) identified patterns of measurable spectral features (peak patterns) that correlated with dechlorination (in)activity, and ANOVA analyses identified 18 potential biomarkers for this process. Statistical clustering of samples with these 18 features identified dechlorination activity more reliably than clustering of samples based only on chlorinated ethene concentration and Dhc 16S rRNA gene abundance data, highlighting the potential value of metabolomic workflows as an innovative site assessment and bioremediation monitoring tool.

Abstract Background Primary care is a critical partner for antimicrobial stewardship efforts given its high human antibiotic usage. Peer comparison audit and feedback (A&F) is often used to reduce inappropriate antibiotic prescribing. The design and implementation of A&F may impact its effectiveness. There are no best practice guidelines for peer comparison A&F in antibiotic prescribing in primary care. Objective To develop best practice guidelines for peer comparison A&F for antibiotic prescribing in primary care in high income countries by leveraging international expertise via the Joint Programming Initiative on Antimicrobial Resistance—Primary Care Antibiotic Audit and Feedback Network. Methods We used a modified Delphi process to achieve convergence of expert opinions on best practice statements for peer comparison A&F based on existing evidence and theory. Three rounds were performed, each with online surveys and virtual meetings to enable discussion and rating of each best practice statement. A five-point Likert scale was used to rate consensus with a median threshold score of 4 to indicate a consensus statement. Results The final set of guidelines include 13 best practice statements in four categories: general considerations (n = 3), selecting feedback recipients (n = 1), data and indicator selection (n = 4), and feedback delivery (n = 5). Conclusion We report an expert-derived best practice recommendations for designing and evaluating peer comparison A&F for antibiotic prescribing in primary care. These 13 statements can be used by A&F designers to optimize the impact of their quality improvement interventions, and improve antibiotic prescribing in primary care.

Abstract Disconcerting reports from different EU countries during the first wave of the COVID-19 pandemic demonstrated the demand for supporting decision instruments and recommendations in case tertiary triage is needed. COVID-19 patients mainly present sequentially, not parallelly, and therefore ex-post triage scenarios were expected to be more likely than ex-ante ones. Decision-makers in these scenarios may be highly susceptible to second victim and moral injury effects, so that reliable and ethically justifiable algorithms would have been needed in case of overwhelming critical cases. To gather basic information about a potential tertiary triage instrument, we designed a three-dimensional instrument developed by an expert group using the Delphi technique. The instrument focused on three parameters: 1) estimated chance of survival, 2) estimated prognosis of regaining autonomy after treatment, and 3) estimated length of stay in the ICU. To validate and test the instrument, we conducted an anonymous online survey in 5 German hospitals addressing physicians that would have been in charge of decision-making in the case of a mass infection incident. Of about 80 physicians addressed, 47 responded. They were presented with 16 fictional ICU case vignettes (including 3 doublets) which they had to score using the three parameters of the instrument. We detected a good construct validity (Cronbach’s Alpha 0.735) and intra-reliability (p

IntroductionSince cannabinoids were partially legalized as prescription medicines in Germany in 2017, they are mostly used when conventional therapies do not suffice. Ambiguities remain regarding use, benefits and risks. This web-based survey explored the perspectives of patients whose experiences are not well enough known to date.MethodsIn an anonymous, exploratory, cross-sectional, one-time web-based observational study, participants receiving cannabinoid therapy on prescription documented aspects of their medical history, diagnoses, attitudes toward cannabinoids, physical symptoms, and emotional states. Participants completed the questionnaires twice here: first regarding the time of the survey and then, retrospectively, for the time before their cannabinoid therapy. Participants were recruited in a stratified manner in three German federal states.ResultsN = 216 participants (48.1% female, aged 51.8 ± 14.0) completed the survey, most of which (72%, n = 155) reported pain as their main reason for cannabinoid therapy. When comparing the current state with the retrospectively assessed state, participants reported greater satisfaction with their overall medical therapy (TSQM II: +47.9 ± 36.5, p

BackgroundMany individuals with intellectual disability (ID) have a sedentary lifestyle. Few interventions aimed at increasing their level of physical activity (PA) have shown lasting effects.AimTo assess the feasibility and acceptability of a pilot intervention study using innovative mobile health (mHealth) support systems to encourage PA in individuals with ID.MethodsNine individuals with ID and a low level of PA, aged 16–36 years, were included in the present convergent triangulation mixed method design. Two mHealth support systems (apps) were developed and tested. PA was measured with a Fitbit smartwatch, accelerometer, the International Physical Activity Questionnaire—Short Form (IPAQ-S), and Goal attainment scaling. Data were collected through online pre-, mid- (4 weeks), and post-intervention (12 weeks) questionnaires and activity trackers. Semi-structured qualitative interviews with participants and/or a family or staff member were held after the 12-week follow-up. Data were analyzed using conventional nonparametric statistics and thematic analyses.ResultsThe response rate and retention to the trial were 16% and 100%, respectively. Data quality was high, except for missing data from Fitbit activity trackers of approximately 30% from the 4- and 12-week follow-up stages. The feasibility challenges with activity trackers include rashes, size, non-acceptance, and loss of motivation. Participants and family members/staff reported interest in the study theme and were pleased with the data collection method. All but one participant achieved their PA goals. Most participants reported being satisfied with the apps as they were enjoyable or provided a reminder for performing physical and other activities. Social support for PA among family members also increased. However, app support from staff and family members was needed, and apps were not used regularly. Two of nine participants (22%) had increased their PA measured as steps per day with Fitbit at the 12-week follow-up.ConclusionsThe acceptability and feasibility of using tailored mobile applications in natural settings to increase PA among adults with ID are promising. This study aligns with previous studies in showing the challenges to increasing PA, which requires the inclusion of family members, staff, and stakeholders. The intervention requires modifications before a randomized controlled trial can be conducted.

Introduction Chronic inflammatory diseases like rheumatoid arthritis (RA) and neurodegenerative disorders like Parkinson’s disease (PD) have recently been associated with a decreased diversity in the gut microbiome, emerging as key driver of various diseases. The specific interactions between gut-borne microorganisms and host pathophysiology remain largely unclear. The microbiome can be modulated by interventions comprising nutrition.The aim of our clinical study is to (1) examine effects of prolonged fasting (PF) and time-restricted eating (TRE) on the outcome parameters and the immunophenotypes of RA and PD with (2) special consideration of microbial taxa and molecules associated with changes expected in (1), and (3) identify factors impacting the disease course and treatment by in-depth screening of microorganisms and molecules in personalised HuMiX gut-on-chip models, to identify novel targets for anti-inflammatory therapy.Methods and analysis This trial is an open-label, multicentre, controlled clinical trial consisting of a cross-sectional and a longitudinal study. A total of 180 patients is recruited. For the cross-sectional study, 60 patients with PD, 60 patients with RA and 60 healthy controls are recruited at two different, specialised clinical sites. For the longitudinal part, 30 patients with PD and 30 patients with RA undergo 5–7 days of PF followed by TRE (16:8) for a period of 12 months. One baseline visit takes place before the PF intervention and 10 follow-up visits will follow over a period of 12 months (April 2021 to November 2023).Ethics and dissemination Ethical approval was obtained to plan and conduct the trial from the institutional review board of the Charité-Universitätsmedizin Berlin (EA1/204/19), the ethics committee of the state medical association (Landesärztekammer) of Hessen (2021–2230-zvBO) and the Ethics Review Panel (ERP) of the University of Luxembourg (ERP 21–001 A ExpoBiome). The results of this study will be disseminated through peer-reviewed publications, scientific presentations and social media.Trial registration number NCT04847011.

BackgroundMedical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and their (still) low prevalence in medical contexts. Against this background, patients’ willingness to provide information is limited. Moreover, it is logistically challenging to reach them with a survey. A thorough knowledge of currently ongoing therapies and their effects and side effects, however, is important for a more appropriate and effective use of cannabinoids in the future. ObjectiveThis study is an exploratory data collection using a representative sample. The main goal is to provide a detailed picture of the current use of medical cannabinoids in Germany. It is intended to identify subgroups that may benefit particularly well or poorly. MethodsWe are conducting a representative, anonymous, cross-sectional, one-time, web-based survey based on mixed methods in 3 German federal states. Health conditions under cannabinoid therapy and before are documented with validated, symptom-specific questionnaires. This allows an estimation of the effect sizes of these therapies. The selection of parameters and questionnaires was based on the results of independent qualitative interviews in advance. Representative samples of the hard-to-reach study population are obtained by cluster sampling via contracted physicians of the statutory health insurance companies. ResultsRecruitment was ongoing until the end of June 2022, with 256 enrolled participants. Validated questionnaires on pain, spasticity, anorexia or wasting, multiple sclerosis, nausea or vomiting, depression, and attention deficit hyperactivity disorder (ADHD) were selected. Symptom scores are being assessed for both current conditions under cannabinoid therapy and conditions prior to this therapy (in retrospect). Validated questionnaires are also used for treatment satisfaction and general quality of life. These are supplemented by existing diagnoses, a detailed medication history, any previous experiences with cannabis or illegal substances, experiences with the prescription process, and sociodemographic data. Based on the results of the previous qualitative interviews, questions were added regarding prior experience with relaxation methods and psychotherapy, personal opinions about cannabinoids, pre-existing or symptom-related psychological trauma, and different experiences with different cannabis-based therapies. ConclusionsThe exploratory mixed methods approach of this project is expected to provide valid and relevant data as a basis for future clinical research. The study design may be representative for a large proportion of outpatients treated with cannabinoids in the German federal states studied. It may have less bias toward social desirability and may provide valuable information in addition to existing studies. Due to the observational and cross-sectional nature of this study, various limitations apply. Causal relations cannot be drawn. Trial RegistrationGerman Clinical Trials Register DRKS00023344; https://drks.de/search/en/trial/DRKS00023344 International Registered Report Identifier (IRRID)DERR1-10.2196/38814

Abstract Background Limitations of life-sustaining interventions in intensive care units (ICUs) exhibit substantial changes over time, and large, contemporary variation across world regions. We sought to determine whether a weighted end-of-life practice score can explain a large, contemporary, worldwide variation in limitation decisions. Methods The 2015–2016 (Ethicus-2) vs. 1999–2000 (Ethicus-1) comparison study was a two-period, prospective observational study assessing the frequency of limitation decisions in 4952 patients from 22 European ICUs. The worldwide Ethicus-2 study was a single-period prospective observational study assessing the frequency of limitation decisions in 12,200 patients from 199 ICUs situated in 8 world regions. Binary end-of-life practice variable data (1 = presence; 0 = absence) were collected post hoc (comparison study, 22/22 ICUs, n = 4592; worldwide study, 186/199 ICUs, n = 11,574) for family meetings, daily deliberation for appropriate level of care, end-of-life discussions during weekly meetings, written triggers for limitations, written ICU end-of-life guidelines and protocols, palliative care and ethics consultations, ICU-staff taking communication or bioethics courses, and national end-of-life guidelines and legislation. Regarding the comparison study, generalized estimating equations (GEE) analysis was used to determine associations between the 12 end-of-life practice variables and treatment limitations. The weighted end-of-life practice score was then calculated using GEE-derived coefficients of the end-of-life practice variables. Subsequently, the weighted end-of-life practice score was validated in GEE analysis using the worldwide study dataset. Results In comparison study GEE analyses, end-of-life discussions during weekly meetings [odds ratio (OR) 0.55, 95% confidence interval (CI) 0.30–0.99], end-of-life guidelines [OR 0.52, (0.31–0.87)] and protocols [OR 15.08, (3.88–58.59)], palliative care consultations [OR 2.63, (1.23–5.60)] and end-of-life legislation [OR 3.24, 1.60–6.55)] were significantly associated with limitation decisions (all P

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BackgroundComplementary and Integrative Medicine (CIM), including self-care healthy life-style promotion strategies, is widely used in Germany. Aim of this study was to assess the use of self-care and lifestyle interventions as well as mental/emotional state experienced during the COVID-19 pandemic.MethodsAn exploratory cross-sectional online study was conducted with adults in Germany through an online survey. Custom-developed questions in respiratory disease-status (including COVID-19), CIM-based self-care/lifestyle interventions and dietary patterns, and mental/emotional state as well as parameters for wellbeing (World Health Organization Well-Being Index, WHO-5) and self-efficacy (General Self-Efficacy Short Scale, GSE-3) were assessed. Data was analyzed using frequency and parametric measures.ResultsThe online survey was performed from January to March 2021 and included 1,138 participants (81.5% female; mean age: 49.2 ± 13.7 years; 54.9% holding a university degree) living in Germany, of which 62 had had a positive SARS-CoV-2 test, 4 an influenza infection and 375 participants other respiratory infections. The following individual health promotion strategies were reported: spending time in nature (90%; n = 1,024), physical activity (69.3%; n = 789), naturopathic remedies (63.1%; n = 718), plant-based diet (56.3%; n = 640), and Mind-Body interventions (54.7%; n = 623). No differences in strategies between individuals with respiratory diseases or the sample overall were found. Well-being had a mean value of 15.2 ± 5 (WHO-5) and self-efficacy 4.1 ± 0.6 (GSE-3). Nearly 8% reported a low mental/emotional state regarding the COVID-19 pandemic.ConclusionSelf-care and lifestyle interventions during the COVID-19 pandemic were reported by participants who were predominantly female, middle-aged, and well-educated. Most participants showed an overall balanced mental/emotional state. Further studies should include a representative control group from the general population.Clinical trial registrationclinicaltrials.gov, identifier NCT04653727.

Abstract Background Acupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients. Methods We conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks. Results Forty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: − 0.9 points (95% CI − 1.6 to − 0.2; p = 0.011) and VAS overall SAR symptoms: − 21.6 mm (95% CI − 36.3 to − 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI − 3.8 to − 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe. Conclusion Results of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310

Abstract Background The mortality of metabolic-obesity phenotypes has been thoroughly studied, but it is not known if or how the association between mortality and body mass index (BMI), waist circumference or a body shape index (ABSI) differ in strata of cardiometabolic health status. Methods We linked data on 12,815 men and women aged 36–79 years from the SAMINOR 1 Survey with mortality data from the Norwegian Cause of Death Registry. We defined metabolically healthy and unhealthy as having zero and ≥ 1, respectively, of the following: MetS, pre-existing diabetes or cardiovascular disease (CVD), or prescribed drugs for high blood pressure, hyperglycaemia or dyslipidaemia. We defined general and abdominal obesity as BMI ≥ 30 kg/m2 and waist circumference ≥ 88 cm (women) or 102 cm (men), respectively, and cross-classified these categories with metabolic status to create metabolically healthy non-obese and obese (MHNO and MHO) and metabolically unhealthy non-obese and obese (MUNO and MUO) phenotypes. We used Cox regression to estimate the hazard ratio (HR) for all-cause and CVD mortality for 1) the four phenotypes and 2) BMI, waist circumference and ABSI fitted with restricted cubic splines. We adjusted for age and lifestyle, and tested for interactions with sex and metabolic status (only continuous measures). Results The MHO phenotype was present in 7.8% of women and 5.8% of men. During a median follow-up of 15.3/15.2 years, 596/938 women/men had died, respectively. The MUNO and MUO groups had higher mortality than the MHNO group. Sex and phenotypes interacted with respect to CVD mortality: relative to the MHNO group, the MHO group had an adjusted HR (95% confidence interval) for CVD mortality of 1.05 (0.38–2.88) in women and 2.92 (1.71–5.01) in men. We found curvilinear associations between BMI/waist circumference and all-cause mortality irrespective of metabolic status. Corresponding relationships with CVD mortality were linear and the slope differed by sex and metabolic status. ABSI was linearly and positively associated with all-cause and CVD mortality in men. Conclusion The relationships between BMI, waist circumference or ABSI and mortality differed by sex, metabolic status and cause of death. Poor metabolic health substantially increases mortality regardless of obesity status.

BackgroundFasting is beneficial in many diseases, including rheumatoid arthritis (RA), with lasting effects for up to 1 year. However, existing data dates back several decades before the introduction of modern therapeutic modalities.ObjectiveThis exploratory RCT compares the effects of a 7-day fast followed by a plant-based diet (PBD) to the effects of the dietary recommendations of the German society for nutrition (Deutsche Gesellschaft für Ernährung, DGE) on RA disease activity, cardiovascular (CV) risk factors, and well-being.MethodsIn this RCT we randomly assigned 53 RA patients to either a 7-day fast followed by an 11-week PBD or a 12-week standard DGE diet. The primary endpoint was the group change from baseline to 12 weeks on the Health Assessment Questionnaire Disability Index (HAQ-DI). Further outcomes included other disease activity scores, body composition, and quality of life.ResultsOf 53 RA patients enrolled, 50 participants (25 per group) completed the trial and were included into the per-protocol analysis. The primary endpoint was not statistically significant. However, HAQ-DI improved rapidly in the fasting group by day 7 and remained stable over 12 weeks (Δ-0.29, p = 0.001), while the DGE group improved later at 6 and 12 weeks (Δ-0.23, p = 0.032). DAS28 ameliorated in both groups by week 12 (Δ-0.97, p < 0.001 and Δ-1.14, p < 0.001; respectively), with 9 patients in the fasting but only 3 in the DGE group achieving ACR50 or higher. CV risk factors including weight improved stronger in the fasting group than in the DGE group (Δ-3.9 kg, p < 0.001 and Δ-0.7 kg, p = 0.146).ConclusionsCompared with a guideline-based anti-inflammatory diet, fasting followed by a plant-based diet showed no benefit in terms of function and disability after 12 weeks. Both dietary approaches had a positive effect on RA disease activity and cardiovascular risk factors in patients with RA.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03856190, identifier: NCT03856190.

Using the first high-resolution geophysical data set collected from the uThukela Banks Marine Protected Area (MPA), we reveal a plethora of hitherto unknown or poorly resolved seabed features. In tandem with several remotely operated vehicle dives, we improve on the previous National Biodiversity Assessment map for the area and reveal a more complex picture of the seabed geology and geomorphology on which the MPA is predicated. The upper slope (-120 m and deeper) is dominated by small canyons, gullies and rills that occasionally extend to the shelf edge and form a series of slumps. Suspected cold-water corals were imaged on the interfluves of the Thukela Canyon. The mid to outer shelf (-60 to -100 m) is mostly rocky, and is composed of Pliocene-age siltstones for the most part. Aeolianite shorelines are found at depths of 60 m and 100 m, in which palaeo-lagoons and parabolic aeolian dune systems are also preserved. These features provide habitat for mesophotic corals and demersal fishes. Overlying and abutting hard rock substrates are unconsolidated sandy sediments that are mobilised by the inshore movement of the Agulhas Current. An inshore mud belt characterised by pockmarks associated with free gas expulsion is mapped for the first time. A well-developed palaeo-drainage pattern is also revealed, posing exciting new opportunities for the study of benthic communities associated with palaeo-estuaries and lagoons now exposed at the seabed. Several new habitats, both inside and out of the MPA boundaries, should form the basis for future research within the MPA, in addition to informing expansions of the MPA. Significance: • Using a newly collected geophysical data set, we provide an unprecedented glimpse into the newly proclaimed uThukela Banks Marine Protected Area. • We reveal a complexity of marine habitats hitherto unknown from previous biodiversity surveys. These habitats include areas of possible expansion given the recognition of keystone species that occur just outside the MPA limits.

Ultra-high performance liquid chromatography–high-resolution mass spectrometry (UPHLC–HRMS) is used to discover and monitor single or sets of biomarkers informing about metabolic processes of interest. The technique can detect 1000’s of molecules (i.e., metabolites) in a single instrument run and provide a measurement of the global metabolome, which could be a fingerprint of activity. Despite the power of this approach, technical challenges have hindered the effective use of metabolomics to interrogate microbial communities implicated in the removal of priority contaminants. Herein, our efforts to circumvent these challenges and apply this emerging systems biology technique to microbiomes relevant for contaminant biodegradation will be discussed. Chlorinated ethenes impact many contaminated sites, and detoxification can be achieved by organohalide-respiring bacteria, a process currently assessed by quantitative gene-centric tools (e.g., quantitative PCR). This laboratory study monitored the metabolome of the SDC-9™ bioaugmentation consortium during cis-1,2-dichloroethene (cDCE) conversion to vinyl chloride (VC) and nontoxic ethene. Untargeted metabolomics using an UHPLC-Orbitrap mass spectrometer and performed on SDC-9™ cultures at different stages of the reductive dechlorination process detected ~10,000 spectral features per sample arising from water-soluble molecules with both known and unknown structures. Multivariate statistical techniques including partial least squares-discriminate analysis (PLSDA) identified patterns of measurable spectral features (peak patterns) that correlated with dechlorination (in)activity, and ANOVA analyses identified 18 potential biomarkers for this process. Statistical clustering of samples with these 18 features identified dechlorination activity more reliably than clustering of samples based only on chlorinated ethene concentration and Dhc 16S rRNA gene abundance data, highlighting the potential value of metabolomic workflows as an innovative site assessment and bioremediation monitoring tool.

BackgroundSeveral studies have shown that individuals with intellectual disabilities (IDs) have low levels of physical activity (PA), and intervention studies on PA suggest inconsistent evidence. The use of technology as a means of motivation for PA has yet to be extensively explored and needs to be further investigated. ObjectiveWe aim to assess the feasibility and acceptability of procedures for an intervention arm in a future trial on mobile health (mHealth) to support PA for individuals with IDs. In addition, we aim to examine how the use of technology can influence motivation for PA among participants, their caregivers, and staff members. MethodsA mixed methods pilot study of an intervention arm will be carried out in a planned randomized controlled trial (RCT). Ten participants with ID and their caregivers or a staff member will be included. Information will always be provided by a caregiver or a staff member, or participants with ID if possible. Assessments will be carried out at baseline, follow-up after 4 weeks, and 12 weeks, and include questionnaires on PA, social support, self-efficacy, and challenging behavior. PA will be measured with 2 different activity trackers (Fitbit and Axivity) for 1 week at all assessments. Feasibility will be assessed as recruitment and adherence rate, missing data, usability of the motivational mHealth tool, and estimates of effectiveness. Acceptability of study procedures, activity measures, and motivation for participation in PA will be additionally assessed with qualitative methods at the end of the intervention. ResultsEnrollment commenced in May 2021. Data collection was completed in March 2022. ConclusionsThis pilot study will evaluate the feasibility and acceptability of study procedures of the intervention arm of a planned RCT to address feasibility issues, improve study procedures, and estimate effectiveness of the study measures. How the use of technology can influence motivation for PA will also be examined, which can help guide and improve future PA interventions involving the use of technology. Trial RegistrationClinicalTrials.gov NCT04929106; https://clinicaltrials.gov/ct2/show/NCT04929106 International Registered Report Identifier (IRRID)DERR1-10.2196/37849

Nutritional modification including fasting has been shown to reduce cardiometabolic risk linked to western diet. Here the authors show implementation of fasting resulted in alterations to the intestinal microbiota, and circulating immune cells, improving blood pressure and body weight in patients with metabolic syndrome.

Intermittent religious fasting increases the risk of hypo- and hyperglycemia in individuals with diabetes, but its impact on those without diabetes has been poorly investigated. The aim of this preliminary study was to examine the effects of religious Bahá'í fasting (BF) on glycemic control and variability and compare these effects with time-restricted eating (TRE). In a three-arm randomized controlled trial, 16 subjects without diabetes were assigned to a BF, TRE, or control group. Continuous glucose monitoring and food intake documentation were conducted before and during the 19 days of the intervention, and the 24 h mean glucose and glycemic variability indices were assessed. The BF and TRE groups, but not the control group, markedly reduced the daily eating window while maintaining macronutrient composition. Only the BF group decreased caloric intake (−677.8 ± 357.6 kcal, p = 0.013), body weight (−1.92 ± 0.95 kg, p = 0.011), and BMI (−0.65 ± 0.28 kg, p = 0.006). Higher maximum glucose values were observed during BF in the within-group (+1.41 ± 1.04, p = 0.039) and between-group comparisons (BF vs. control: p = 0.010; TRE vs. BF: p = 0.022). However, there were no alterations of the 24 h mean glucose, intra- and inter-day glycemic variability indices in any group. The proportions of time above and below the range (70–180 mg/dL) remained unchanged. BF and TRE do not exhibit negative effects on glycemic control and variability in subjects without diabetes. [ABSTRACT FROM AUTHOR]

Abstract Background/objectives A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet. Methods This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350–400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments. Discussion/planned outcomes Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission. Trial registration ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017

Summary Background The relationships between metabolic markers and obesity measures may differ by ethnicity, sex, and height. Questions have been posed whether these relationships differ by ethnicity in the population in Northern Norway, but this has not been explored yet. Objectives Investigate the relationships between metabolic markers and obesity measures in Sami and non‐Sami and explore the impact of stature. Methods In total, 13 921 men and women aged 30 and 36 to 79 years (22.0% Sami) from a population‐based cross‐sectional survey in Norway, the SAMINOR 1 Survey (2003‐2004, 57.2% attendance), were included. Relationships between triglycerides, high‐density lipoprotein cholesterol, glucose, systolic/diastolic blood pressure (BP), metabolic syndrome and diabetes mellitus as outcomes, and body mass index (BMI), waist circumference (WC), and waist‐to‐height ratio (WHtR), respectively, were modelled using fractional polynomial regression. Appropriate interaction analyses and adjustments were made. Results The non‐Sami were approximately 6 cm taller than the Sami. No interactions were found between ethnicity and obesity. At the same levels of WC, BMI, or WHtR, levels of lipids and BP differed marginally between Sami and non‐Sami, but these were eliminated by height adjustment, with one exception: At any given WC, BMI, or WHtR, Sami had approximately 1.4 mmHg (95% CI, −2.1 to −0.7) lower systolic BP than non‐Sami (P values < .001). Conclusions Height explained the marginal ethnic differences in metabolic markers at the same level of obesity, except for systolic BP, which was lower in Sami than in non‐Sami at any given BMI, WC, or WHtR.

Abstract Background Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. Ketone bodies that are produced during fasting diets (FDs) and ketogenic diets (KDs) are an alternative and presumably more efficient energy source for the brain. Studies on mice with experimental autoimmune encephalomyelitis showed beneficial effects of KDs and FDs on disease progression, disability, cognition and inflammatory markers. However, clinical evidence on these diets is scarce. In the clinical study protocol presented here, we investigate whether a KD and a FD are superior to a standard diet (SD) in terms of therapeutic effects and disease progression. Methods This study is a single-center, randomized, controlled, parallel-group study. One hundred and eleven patients with relapsing–remitting MS with current disease activity and stable immunomodulatory therapy or no disease-modifying therapy will be randomized to one of three 18-month dietary interventions: a KD with a restricted carbohydrate intake of 20–40 g/day; a FD with a 7-day fast every 6 months and 14-h daily intermittent fasting in between; and a fat-modified SD as recommended by the German Nutrition Society. The primary outcome measure is the number of new T2-weighted MRI lesions after 18 months. Secondary endpoints are safety, changes in relapse rate, disability progression, fatigue, depression, cognition, quality of life, changes of gut microbiome as well as markers of inflammation, oxidative stress and autophagy. Safety and feasibility will also be assessed. Discussion Preclinical data suggest that a KD and a FD may modulate immunity, reduce disease severity and promote remyelination in the mouse model of MS. However, clinical evidence is lacking. This study is the first clinical study investigating the effects of a KD and a FD on disease progression of MS. Trial registration ClinicalTrials.gov, NCT03508414. Retrospectively registered on 25 April 2018.

Plant-based diets are associated with numerous health benefits but also bear risks of micronutrient deficiencies if inadequately planned. The risk of nutrient deficiencies can be reliably reduced by supplementation but requires risk-awareness. We distributed a paper-and-pencil questionnaire to n = 902 healthcare professionals attending a congress on plant-based nutrition (VegMed 2018, Berlin). On the day of the survey (21 April 2018), n = 475 questionnaires were returned and analyzed descriptively. Of the n = 213 strict vegan participants, 2% (n = 5) took no supplements at all. All supplementing vegans reported taking vitamin B12. Almost three-quarters of vegans (73%, n = 152) took vitamin D, and 22% (n = 45) reported taking omega-3 fatty acids. Iron was supplemented by 13% (n = 28), iodine by 12% (n = 25), calcium by 11% (n = 22), zinc by 7% (n = 14), magnesium by 5% (n = 11), and selenium by 4% (n = 9). For 11%, a supplement other than vitamin B12 was subjectively most important. Nearly 50% had their vitamin B12 levels laboratory tested at least once a year; nearly one-quarter reported testing every two years, and another one-quarter rarely or never. Participants following a vegan diet were better informed about institutional recommendations of the German Nutrition Society and the Academy of Nutrition and Dietetics for vegan diets than participants following vegetarian or omnivorous diets. Vegan nutrition in pregnancy/lactation period and childhood was considered most appropriate by vegans. Despite a high awareness of potential health risks associated with vitamin B12 deficiency on a strict vegan diet and a comprehensive understanding of the official dietary recommendations of nutrition societies, use of supplements and performance of regular laboratory tests were only moderate among vegan healthcare professionals. Considering the paramount importance of adequate supplementation of critical nutrients to avoid nutrient deficiencies, scientific and public discourse should be further facilitated. Further investigation of the supplementation behavior of vegan health professionals could be of particular interest, as a possible correlation with the quality of their own nutrition counseling is not inconceivable.

Background: Time-restricted eating is a promising dietary strategy for weight loss, glucose and lipid metabolism improvements, and overall well-being. However, human studies demonstrated contradictory results for the restriction of food intake to the beginning (early TRE, eTRE) or to the end of the day (late TRE, lTRE) suggesting that more carefully controlled studies are needed.Objective: The aim of the ChronoFast trial study is to determine whether eTRE or lTRE is a better dietary approach to improve cardiometabolic health upon minimized calorie deficits and nearly stable body weight.Methods: Here, we present the study protocol of the randomized cross-over ChronoFast clinical trial comparing effects of 2 week eTRE (8:00 to 16:00 h) and lTRE (13:00 to 21:00 h) on insulin sensitivity and other glycemic traits, blood lipids, inflammation, and sleep quality in 30 women with overweight or obesity and increased risk of type 2 diabetes. To ensure timely compliance and unchanged dietary composition, and to minimize possible calorie deficits, real-time monitoring of dietary intake and body weight using a smartphone application, and extensive nutritional counseling are performed. Continuous glucose monitoring, oral glucose tolerance test, 24 h activity tracking, questionnaires, and gene expression analysis in adipose tissue and blood monocytes will be used for assessment of study outcomes.Discussion: The trial will determine whether eTRE or lTRE is more effective to improve cardiometabolic health, elucidate underlying mechanisms, and contribute to the development of recommendations for medical practice and the wider population.Clinical Trial Registration:www.ClinicalTrials.gov, Identifier [NCT04351672]

Numerous medical studies have documented vegetarian diets as having various health benefits. Studies have also compared vegetarians with other dietary groups from a socio-psychological perspective. The objective of this review is to investigate the differences between vegetarians and omnivores in terms of their personality profiles, values, and empathy skills. A search was conducted across three electronic databases. Non-randomized, observational, cross-sectional, and cohort studies were eligible. Outcomes provided information about the differences between the above-mentioned dietary groups regarding their personality profiles, values, and empathy skills. A shortened version of the Newcastle–Ottawa Scale was used to assess the risk of bias for the included studies. Of the 2,513 different studies found, 25 (total number of participants n = 23,589) were ultimately included. These studies indicate that vegetarians significantly differ from omnivores in their personalities, values, and ability to be empathetic. Omnivorism is associated with an increased orientation toward social dominance, greater right-wing authoritarianism, and, in line with this, a stronger tendency to be prejudiced. Vegetarianism is associated with greater openness and empathy. The values of vegetarians are based more on universalism, hedonism, stimulation, and self-direction, whereas the values of omnivores are based more on the idea of power. To answer a narrowly defined and clear question, issues such as animal ethics, animal rights, and environmental protection are not considered in this review. The findings of this review, showing marked differences in personality correlating to the choice of diet and the increasing influence of plant-based diets on a global level, indicate that further studies about vegetarianism are warranted.

Aims: To compare the effects of Ayurvedic and conventional nutritional therapy in patients with irritable bowel syndrome (IBS).Methods: Sixty-nine patients with IBS were randomized to Ayurvedic (n = 35) or conventional nutritional therapy according to the recommendations of the German Nutrition Society including the low-FODMAP diet (n = 34). Study visits took place at baseline and after 1, 3, and 6 months. The primary outcome was IBS symptom severity (IBS-SSS) after 3 months; secondary outcomes included stress (CPSS), anxiety and depression (HADS), well-being (WHO-5) and IBS-specific quality of life (IBS-QOL). A repeated measures general linear model (GLM) for intent-to-treat-analyses was applied in this explorative study.Results: After 3 months, estimated marginal means for IBS-SSS reductions were 123.8 [95% confidence interval (95% CI) = 92.8–154.9; p < 0.001] in the Ayurvedic and 72.7 (95% CI = 38.8–106.7; p < 0.001) in the conventional group. The IBS-SSS reduction was significantly higher in the Ayurveda group compared to the conventional therapy group (estimated marginal mean = 51.1; 95% CI = 3.8–98.5; p = 0.035) and clinically meaningful. Sixty-eight percentage of the variance in IBS-SSS reduction after 3 months can be explained by treatment, 6.5% by patients' expectations for their therapies and 23.4% by IBS-SSS at pre-intervention. Both therapies are equivalent in their contribution to the outcome variance. The higher the IBS-SSS score at pre-intervention and the larger the patients' expectations, the greater the IBS-SSS reduction. There were no significant group differences in any secondary outcome measures. No serious adverse events occurred in either group.Conclusion: Patients with IBS seem to benefit significantly from Ayurvedic or conventional nutritional therapy. The results warrant further studies with longer-term follow-ups and larger sample sizes.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03019861, identifier: NCT03019861.

Objectives: The present study examined the effects of a yoga and mindfulness-based programme on the autonomic nervous system of primary school children by using heart rate variability parameters. Design: A two-arm non-randomised controlled trial compared an integrated yoga and mindfulness-based programme (16 weeks) to conventional primary school lessons. Setting: Primary school classrooms and conference rooms. Interventions: Participants were allocated to a 16-week integrated yoga-based programme or conventional school lessons. A subgroup was randomised to receive 24h electrocardiogram-recordings. Main outcome measures: Heart rate variability indices were measured, both linear (time and frequency domain) and non-linear (symbolic dynamics, compression entropy), calculated from 30-minute extracts of Holter-electrocardiogram-recordings. Assessments were conducted at baseline and at the end of intervention. Results: 40 participants (42.5% female) were included into the analysis of HRV. No significant changes in heart rate variability parameters were observed between the groups after 16 weeks. In the intervention group, a trend towards increased parasympathetic activity could be seen over time, although not significantly enhanced compared to the control group. Conclusion: Results obtained here do not clearly show that children in German primary school settings benefit from an integrated yoga-based intervention. However, exploratory post-hoc analyses point interestingly to an increased nocturnal parasympathetic activity in the intervention group. Further studies are required with high-quality study designs, larger sample sizes and longer-term follow-ups.