Effectiveness of a fortified drink in improving B vitamin biomarkers in older adults: a controlled intervention trial.

BACKGROUND: Older adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in the B vitamin biomarker status. METHODS: A double-blinded randomised controlled trial was performed in parallel at University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria (i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming > 4 portions of B vitamin-fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease). Recruited participants meeting the inclusion criteria were randomised (by sex and study centre) to receive daily for 16 weeks either B vitamin-fortified or placebo drinks as developed by Smartfish, Norway. Each B vitamin-fortified drink (200 ml) contained 200 µg folic acid, 10 µg vitamin B12, 10 mg vitamin B6 and 5 mg riboflavin, while the placebo was an identical, isocaloric formulation without added B vitamins. Fasting blood samples were collected pre- and post-intervention which were used to measure the primary outcome of change in B vitamin biomarker levels. RESULTS: A total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed (37 in the active and 33 in the placebo groups). Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamin biomarkers in the active compared to placebo groups: p < 0.01 for each of serum folate, serum vitamin B12 and plasma pyridoxal 5'-phosphate (vitamin B6) and the functional riboflavin biomarker, erythrocyte glutathione reductase activation coefficient (EGRac). Correspondingly, a significant lowering of serum homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L was observed in response to the active treatment (P < 0.001). Similar results were seen in a per-protocol analysis. CONCLUSIONS: The results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention option to improve B vitamin status in older adults. Trial registration ISRCTN, ISRCTN61709781-Retrospectively registered, https://www.isrctn.com/ISRCTN61709781.

Consumption of a soy drink has no effect on cognitive function but may alleviate vasomotor symptoms in post-menopausal women; a randomised trial.

PURPOSE: Cognitive decline is commonly reported during the menopausal transition, with memory and attention being particularly affected. The aim of this study was to investigate the effects of a commercially available soy drink on cognitive function and menopausal symptoms in post-menopausal women. METHODS: 101 post-menopausal women, aged 44-63 years, were randomly assigned to consume a volume of soy drink providing a low (10 mg/day; control group), medium (35 mg/day), or high (60 mg/day) dose of isoflavones for 12 weeks. Cognitive function (spatial working memory, spatial span, pattern recognition memory, 5-choice reaction time, and match to sample visual search) was assessed using CANTAB pre- and post-the 12 week intervention. Menopausal symptoms were assessed using Greene's Climacteric Scale. RESULTS: No significant differences were observed between the groups for any of the cognitive function outcomes measured. Soy drink consumption had no effect on menopausal symptoms overall; however, when women were stratified according to the severity of vasomotor symptoms (VMS) at baseline, women with more severe symptoms at baseline in the medium group had a significant reduction (P = 0.001) in VMS post-intervention (mean change from baseline score: - 2.15 ± 1.73) in comparison to those with less severe VMS (mean change from baseline score: 0.06 ± 1.21). CONCLUSIONS: Soy drink consumption had no effect on cognitive function in post-menopausal women. Consumption of ~ 350 ml/day (35 mg IFs) for 12 weeks significantly reduced VMS in those with more severe symptoms at baseline. This finding is clinically relevant as soy drinks may provide an alternative, natural, treatment for alleviating VMS, highly prevalent among western women.

Workflow Requirements for Cost-of-Care Conversations in Outpatient Settings Providing Oncology or Primary Care: A Qualitative, Human-Centered Design Study.

Background: Patients prefer to discuss costs in the clinical setting, but physicians and teams may be unprepared to incorporate cost discussions into existing workflows. Objective: To understand and improve clinical workflows related to cost-of-care conversations. Design: Qualitative human-centered design study. Setting: 2 integrated health systems in the U.S. Pacific Northwest: a system-wide oncology service line and a system-wide primary care service line. Participants: Clinicians, clinical team members, operations staff, and patients. Measurements: Ethnographic observations were made at the integrated health systems, assessing barriers to and facilitators of discussing costs with patients. Three unique patient experiences of having financial concerns addressed in the clinic were designed. These experiences were refined after in-person interviews with patients (n = 20). Data were synthesized into a set of clinical workflow requirements. Results: Most patient cost concerns take 1 of 3 pathways: informing clinical care decision making, planning and budgeting concerns, and addressing immediate financial hardship. Workflow requirements include organizational recognition of the need for clinic-based cost-of-care conversations; access to cost and health plan benefit data to support each conversation pathway; clear team member roles and responsibilities for addressing cost-of-care concerns; a patient experience where cost questions are normal and each patient's preferences and privacy are respected; patients know who to go to with cost questions; patients' concerns are documented to minimize repetition to multiple team members; and patients learn their expected out-of-pocket costs before treatment begins. Limitation: Results may have limited generalizability to other health care settings, and the study did not test the effectiveness of the workflows developed. Conclusion: Clinic-based workflows for cost-of-care conversations that optimize patients' care experience require organizational commitment to addressing cost concerns, clear roles and responsibilities, appropriate and complete data access, and a team-based approach. Primary Funding Source: Robert Wood Johnson Foundation.

Colorectal cancer survivors' challenges to returning to work: A qualitative study.

OBJECTIVE: To assess the challenges and needs of colorectal cancer (CRC) survivors in maintaining employment and returning to work (RTW) from the perspectives of both CRC survivors and employers in the United States. METHODS: Semi-structured interviews with CRC survivors (n = 10) and employers (n = 4) were transcribed, coded and thematically analysed using NVivo 12 software. RESULTS: Workplace challenges for survivors included the following: inadequate availability of paid and unpaid leave, limited availability of workplace accommodations, and employers' lack of knowledge about CRC and the recovery process. Survivors were concerned about the lack of adequate financial resources to take unpaid leave and the need to relearn control of bodily functions. Workplace challenges for employers of cancer survivors included the following: limited institutional flexibility to provide individualised accommodations, communication with frontline managers about leave availability for employees and communication with employees about legal protections and limitations. Employers perceived that employees were unwilling to take leave. CONCLUSION: Colorectal cancer survivors in the US face difficult, sometimes insurmountable, challenges when trying to balance their physical and financial needs within the constraints of employment. Employers recognise challenges associated with this concern. Multi-level interventions-ranging from flexible work schedules to training for frontline managers-might facilitate the RTW process.

The effect of a randomized 12-week soy drink intervention on everyday mood in postmenopausal women.

OBJECTIVE: Dietary soy may improve menopausal symptoms, and subsequently mediate mood. This novel study examines various doses of dietary soy drink on everyday mood stability and variability in postmenopausal women. METHODS: Community-dwelling women (n = 101), within 7 years postmenopause, consumed daily either a low (10 mg, n = 35), medium (35 mg, n = 37), or high (60 mg, n = 29) dose of isoflavones, for 12 weeks. Menopausal symptoms and repeated measures of everyday mood (positive [PA] and negative [NA] affect) (assessed at four time points per day for 4 consecutive days, using The Positive and Negative Affect Schedule) were completed at baseline and follow-up. RESULTS: The dietary soy intervention had no effect on everyday mood stability (for PA [F{2,70} = 0.95, P = 0.390] and NA [F{2,70} = 0.72, P = 0.489]) or variability (for PA [F{2,70} = 0.21, P = 0.807] and for NA [F{2,70} = 0.15, P = 0.864]), or on menopausal symptoms (for vasomotor [F{2,89} = 2.83, P = 0.064], psychological [F{2,88} = 0.63, P = 0.535], somatic [F{2,89} = 0.32, P = 0.729], and total menopausal symptoms [F{2,86} = 0.79, P = 0.458]). There were between-group differences with the medium dose reporting higher PA (low, mean 24.2, SD 6; and medium, mean 29.7, SD 6) and the low dose reporting higher NA (P = 0. 048) (low, mean 11.6, SD 2; and high, mean 10.6, SD 1) in mood scores. Psychological (baseline M = 18 and follow-up M = 16.5) and vasomotor (baseline M = 4.2 and follow-up M = 3.6) scores declined from baseline to follow-up for the overall sample. CONCLUSIONS: Soy isoflavones had no effect on mood at any of the doses tested. Future research should focus on the menopause transition from peri to postmenopause as there may be a window of vulnerability, with fluctuating hormones and increased symptoms which may affect mood.

Obesity, whole blood serotonin and sex differences in healthy volunteers.

BACKGROUND: Obesity is a growing problem throughout Europe, where the rate has more than doubled over the past 20 years. Reduced circulating serotonin may contribute to the development of obesity. This study aimed to explore associations between whole blood (WB) serotonin concentrations and anthropometric measures. METHODS: Healthy adult volunteers (N = 68) gave whole blood samples for measurement of WB serotonin, and underwent BMI waist circumference (WC) and waist-to-hip ratio (WHR) assessment as well as DEXA (dual energy X-ray absorptiometry) scans for anthropometric parameters. Student's t-tests determined differences in WB serotonin and anthropometric measures between sexes. Partial Pearson's correlations were carried out on anthropometric measures and WB serotonin. RESULTS: For the whole sample, WB serotonin was significantly negatively correlated with BMI, WC, WHR as well as android, gynoid and total % body fat. Analysis by sex showed significant negative correlations between WB serotonin and android, gynoid as well as total fat in males, but not in females. CONCLUSION: This dichotomy between the sexes implies that there may be sex differences in the way that serotonin interplays with the development of obesity and body fat distribution.

The Greater Yellowstone Ecosystem: challenges for regional ecosystem management.

An adaptive management approach is necessary but not sufficient to address the long-term challenges of the Greater Yellowstone Ecosystem (GYE). Adaptive management, in turn, has its own particular challenges, of which we focus on two: science input, and stakeholder engagement. In order to frame our discussion and subsequent recommendations, we place the current management difficulties into their historical context, with special emphasis on the 1990 Vision document, which attempted a broad synthesis of management goals for the ecosystem. After examining these two key challenges in the context of the GYE, we make several recommendations that would allow for more effective ecosystem management in the long term. First, we recommend adoption of the GYE as a site for long-term science research and monitoring with an emphasis on integrative research, long-term federal funding, and public dissemination of data. Second, we conclude that a clearer prioritization of legislative mandates would allow for more flexible ecosystem management in the GYE, a region where conflicting mandates have historically led to litigation antithetical to effective ecosystem management. Finally, we recommend a renewed attempt at an updated Vision for the Future that engages stakeholders (including local landholders) substantively from the outset.

Developing an optimal river typology for biological elements within the Water Framework Directive.

The Water Framework Directive requires a river classification based on environmental variables (a typology) to be created as a structure for reporting ecological status. A single permutation procedure, utilising the same variables repeatedly but with different categorical divisions, enabled both the choice of variables and the boundary divisions for these variables to be optimised simultaneously in the development of the typology. This, in addition to a data set which appropriately combined different biological elements, enabled a typology to be developed which was far more effective than a System A, CCA-derived or expert opinion-based typology in segregating communities. This optimal typology could be used to improve the performance of ecological quality assessment methods.