OBJECTIVES:This study aimed to assess if hormonal contraception administered orally (combined oral contraceptive pill, COC) or vaginally (contraceptive vaginal ring) differentially affected bone calcium retention in young females. STUDY DESIGN:Reproductive aged females (18-35 years) not using hormonal contraception were dosed with 50 nCi 41Ca as CaCl2 in 10 mL of sterile saline (0.9%). Following an equilibration phase of ≥100 days and a baseline of two menstrual cycles, participants used COC and the ring for two cycles (49 days) each, in a randomized order, separated and followed by washouts of two menstrual cycles. Twenty-four-hour urine samples were collected monthly during equilibration and every around 10 days during baseline, interventions, and washouts to assess bone calcium retention through accelerator mass spectrometry analysis of the 41Ca:Ca ratio in urine. The effect of each contraception was determined by comparing 41Ca:Ca measured during each contraception intervention to 41Ca:Ca measured during the "control" (baseline and washout) phases using linear models and generalized linear mixed models. RESULTS:Eight reproductive aged females were studied. Compared with control phases (baseline and washouts), COC resulted in greater bone calcium retention (11.3%, 95% CI: 6.7%, 15.6%). The ring did not alter bone calcium retention (4.2%, 95% CI: -6.6%, 13.9%). COC produced a greater change in calcium retention than the ring (p = 0.03). CONCLUSION:Although many factors contribute to bone health, short-term COC improved bone calcium retention, suggesting a potential benefit of COC to bone in females. Conversely, the ring did not alter calcium retention, and may be neither beneficial nor deleterious for bone. IMPLICATIONS:In this study, the effects of oral (pill) vs. vaginal (ring) hormonal contraception on bone calcium retention were assessed in young females. The pill improved bone calcium retention, suggesting a potential beneficial effect on bone health; the ring did not change bone calcium retention compared with control (no contraception).
BACKGROUND:The lack of a widely accepted, broadly validated tool for diagnosing malnutrition in hospitalized patients limits the ability to assess the integral role of nutrition as an input and outcome of health, disease, and treatment. OBJECTIVES:This study aimed to evaluate the predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (ASPEN) indicators to diagnose malnutrition (AAIM) tool and determine if it can be simplified. METHODS:A prospective cohort study was conducted from August 2019 to September 2022 with 32 hospitals in United States. At baseline, 290 adult patients were evaluated for a diagnosis of malnutrition using the AAIM tool, which assesses weight loss, inadequate energy intake, subcutaneous fat and muscle loss, edema, and hand grip strength. Healthcare outcomes were extracted from the medical record: composite incidence of emergency department (ED) visits and hospital readmissions within 90 d postdischarge; length of hospital stay (LOS); and Medicare Severity Disease Related Group (MS-DRG) relative weight (i.e., healthcare resource utilization). We used multilevel, multivariable negative binomial or generalized linear regression models to evaluate relationships between malnutrition diagnosis and healthcare outcomes. RESULTS:After adjusting for disease severity and acuity and sociodemographic characteristics, individuals diagnosed with severe malnutrition had a higher incidence rate of ED visits and hospital readmissions (incidence rate ratio: 1.89; 95% CI: 1.14, 3.13; P = 0.01), and individuals diagnosed with moderate malnutrition had a 25.2% longer LOS (95% CI: 2.0%, 53.7%; P = 0.03) and 15.1% greater healthcare resource utilization (95% CI: 1.6%, 31.9%; P = 0.03) compared with individuals with no malnutrition diagnosis. Observed relationships remained consistent when only considering malnutrition diagnoses supported by at least 2 of these indicators: weight loss, subcutaneous fat loss, muscle wasting, and inadequate energy intake. CONCLUSIONS:Findings from this multihospital study confirm the predictive validity of the original or simplified AAIM tool and support its routine use for hospitalized adult patients. This trial was registered at clinicaltrials.gov as NCT03928548 (https://classic. CLINICALTRIALS:gov/ct2/show/NCT03928548).
Quantum error correction with erasure qubits promises significant advantages over standard error correction due to favorable thresholds for erasure errors. To realize this advantage in practice requires a qubit for which nearly all errors are such erasure errors, and the ability to check for erasure errors without dephasing the qubit. We demonstrate that a "dual-rail qubit" consisting of a pair of resonantly coupled transmons can form a highly coherent erasure qubit, where transmon $T_1$ errors are converted into erasure errors and residual dephasing is strongly suppressed, leading to millisecond-scale coherence within the qubit subspace. We show that single-qubit gates are limited primarily by erasure errors, with erasure probability $p_\text{erasure} = 2.19(2)\times 10^{-3}$ per gate while the residual errors are $\sim 40$ times lower. We further demonstrate mid-circuit detection of erasure errors while introducing $< 0.1\%$ dephasing error per check. Finally, we show that the suppression of transmon noise allows this dual-rail qubit to preserve high coherence over a broad tunable operating range, offering an improved capacity to avoid frequency collisions. This work establishes transmon-based dual-rail qubits as an attractive building block for hardware-efficient quantum error correction.
Background: Preclinical studies suggest that blueberry consumption is associated with improved bone health.Objectives: We conducted a blueberry dose-response study in ovariectomized (OVX)-rats that informed a study in postmenopausal women using the urinary appearance of calcium (Ca) tracers from prelabeled bone to reflect changes in bone balance. We hypothesized that blueberry consumption would reduce bone loss in a dose-dependent manner compared with no treatment.Methods: OVX rats were fed 4 doses of blueberry powder (2.5%, 5%, 10%, and 15%) in randomized order to determine bone 45Ca retention. Fourteen healthy, nonosteoporotic women >4 y past menopause were dosed with 50 nCi of 41Ca, a long-lived radioisotope, and equilibrated for 5 mo to allow 41Ca deposition in bone. Following a 6-wk baseline period, participants were assigned to a random sequence of 3 6-wk interventions, a low (17.5 g/d), medium (35 g/d), or high (70 g/d) dose of freeze-dried blueberry powder equivalent to 0.75, 1.5, or 3 cups of fresh blueberries incorporated into food and beverage products. Urinary 41Ca:Ca ratio was measured by accelerator mass spectrometry. Serum bone resorption biomarkers and urinary polyphenols were measured at the end of each control and intervention period. Data were analyzed using a linear mixed model and repeated measures analysis of variance.Results: In both OVX rats and postmenopausal women, blueberry interventions benefited net bone calcium balance at lower but not at higher doses. In women, net bone calcium retention increased by 6% with the low (95% CI: 2.50, 8.60; P < 0.01) and 4% with the medium (95% CI: 0.96, 7.90; P < 0.05) dose compared with no treatment. Urinary excretion of hippuric acid increased dose-dependently with blueberry consumption. No significant relation-ships were found between bone resorption biomarkers, 25-hydroxyvitamin D, and interventions.Conclusions: Moderate consumption (<1 cup/d) of blueberries may be an effective strategy to attenuate bone loss in healthy postmenopausal women. This trial was registered at clinicaltrials.gov as NCT02630797.
Epidemiological studies have shown associations between polyphenol-rich fruit intake and bone health, and preclinical studies have shown that blueberries improve bone health. To determine the genotype and dose of blueberries that are effective in ameliorating age-related bone loss, a multi-institutional team of investigators performed in vitro, preclinical, and clinical studies on blueberry varieties that differed in flavonoid profiles. Principal component analysis was used to select blueberry genotypes that varied in anthocyanin profiles. Total phenolic content did not predict the bioavailability of polyphenolic compounds in rats. A range in bioavailability was observed in individual polyphenolic compounds across genotypes. Both alpha and beta diversity analyses indicated that gut microbiome profiles varied with blueberry dose in rats. Additionally, the identification of specific taxa, such as Prevotellaceae_UCG-001 and Coriobacteriales, increasing after blueberry consumption adds to the mounting evidence of their role in polyphenol metabolism. All of the sources of variation can inform blueberry breeding practices to influence precision nutrition.
The potential of chicken eggs as a nutritionally complete protein and source of key micronutrients during the first 1000 days post-conception has been progressively recognized across the globe, particularly in resource-poor settings. Fluctuation of egg nutrient content by season is relatively unknown, which may influence international food composition databases and outcomes in intervention studies using egg supplementation. To better interpret the findings of The Saqmolo' Project, we conducted comprehensive nutrient analyses on eggs produced during the wet and dry seasons in the highlands of central Guatemala. We randomly collected 36 shell eggs from a local farm during both seasons, hard-boiled, and prepared them for transport to the United States, where they were pooled and assessed for their nutrient composition. Methods of the Association of Official Analytical Chemists, the American Oil Chemists Society, and the American Association of Cereal Chemists were utilized to determine total energy, moisture, ash, total protein, total fat, fatty acids, total carbohydrates, 12 vitamins, 11 minerals, and carotenoids, by season, in some instances with modifications. Differences in nutrient composition between de-shelled hard-boiled eggs collected between seasons were assessed using an analysis of variance (ANOVA) and Tukey's family error rate comparison test. Most nutrients in eggs produced in the highlands of central Guatemala differed negligibly (but statistically significantly) based on seasonality. Only vitamins A and E, folate, choline, and calcium fluctuated at clinically significant levels relative to the AI/RDA for infants 7-12 months. Total energy, protein, trans fatty acids, moisture, and vitamin D3 levels did not differ between seasons (p > .05). Further multi-year sampling is needed to examine how seasonal variation affects the nutrient composition of eggs. These data may be used to supplement existing national and regional food composition databases.
Adequate nutrition during the complementary feeding period is critical for optimal child growth and development and for promoting long-term educational attainment and economic potential. To prioritize limited public health resources, there is a need for studies that rigorously assess the influence of multicomponent integrated nutrition interventions in children younger than age 2 years in different contexts. This study aimed to describe the rationale and protocol for the Saqmolo' Project using the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. The Saqmolo' (ie, "egg" in the Mayan language, Kaqchiquel) Project is an individually randomized, partially blinded, controlled comparative effectiveness trial to evaluate the influence of adding delivery of a single whole egg per day to local standard nutrition care (ie, growth monitoring, medical care, deworming medication, multiple micronutrient powders for point-of-use food fortification [chispitas], and individualized complementary and responsive feeding education for caregivers) for 6 months, compared with the local standard nutrition care package alone, on child development, growth, and diet quality measures in rural indigenous Mayan infants aged 6 to 9 months at baseline (N = 1,200). The study is being executed in partnership with the Wuqu' Kawoq/Maya Health Alliance, a primary health care organization located in central Guatemala. Primary outcomes for this study are changes in global development scores, assessed using the Guide for Monitoring Global Development and the Caregiver Reported Child Development Instruments. Secondary outcomes include changes in infant hemoglobin, anthropometric measures (including z scores for weight for age, length for age, weight for length, and head circumference for age), and diet quality as measured using the World Health Organization's infant and young child feeding indicators. The results of the Saqmolo' Project may help to inform public health decision making regarding resource allocation for effective nutrition interventions during the complementary feeding period.
Translational statistics report results of an analysis of data in a way that is designed to facilitate the use of the results as a guide in practical settings. In this sense, they go beyond the basic inferential statistics that are the focus of most applications of statistics. The goal is to reach a target audience whose concern is how to implement results based on what has been learned. This audience may not have the statistical background to understand the fine details of the analysis, but it is essential that they understand what the results mean. We illustrate the fundamental ideas with several examples from a variety of settings.
The isoflavone-rich extracts red clover and soy and the individual isoflavones daidzein and equol protect neuronal cultures against triggers of Parkinson's disease, and rescue motor deficits in rats exposed to the neurotoxin 6-OHDA.
Studies in Ecuador and Malawi have demonstrated mixed effects of interventions involving daily complementary feeding of eggs on child growth. For example, in Malawi, the egg intervention had no overall effect on child development. There is a need to test the effects of egg interventions on child growth and development in other settings with high prevalence of stunting and in the context of other nutritional interventions. The Saqmolo' (i.e.,"egg" in the Mayan language, Kaqchiquel) study aims to evaluate the impact of adding 1 egg per day to local standard nutrition care (LSNC) on child development, in rural Maya infants from Guatemala. In a community-based, individually randomized, controlled comparative effectiveness trial among rural indigenous Maya children (n = 1200), starting at 6–9 months at baseline, we will compare the impact of adding one egg per day to LSNC with LSNC alone. LSNC includes: growth monitoring, medical care, deworming medication, multiple micronutrient powders for point of use food fortification, and individualized complementary and responsive feeding education for caregivers. Intervention and control groups will be visited once per month during 6-months and adherence will be monitored during the visits and through phone calls for the first 2 months in both groups at the same frequency. The primary outcome is differences in child global development (measured by Caregiver Reported Child Development Instruments –CREDI-and the Guide for Monitoring Child Development GMCD); secondary outcomes include: growth (z-scores for weight for age, length for age, weight for length, and head circumference for age), and diet quality (using the World Health Organization's infant and young child feeding indicators). N/A (submitting study protocol abstract). This study will provide new evidence on the potential effect of increased egg accessibility in high prevalence stunting areas along with integrated nutrition care on child development. The results may help to inform public health decision-making regarding resource allocation for effective nutrition interventions during the complementary feeding period in Guatemala. This work was supported by the Academy of Nutrition and Dietetics Foundation via an investigator-initiated research grant from the Egg Nutrition Center.
Abstract Aim Clinical governance states that patients should have a named Consultant during their in-patient stay. In our institution, every bed has a whiteboard above it, which mentions the name of the patient and the responsible Consultant. This should correspond with the electronic system, TrakCare. Ouraim was to audit and look into the accuracy of this practice, in order to improve the efficacy of ward-rounds and hence improve patient care and safety. Method Data was collected for general surgery and urology receiving wards over 3 consecutive days and was matched to the data available on the electronic system, TrakCare. Intervention was made in the form of verbal and written communication with the nursing staff and junior doctors. Effect of intervention was assessed 2 weeks later. Results n = 38 bed-boards were assessed. The first cycle of the audit demonstrated that 7 (18.4%) had either incorrect or no entries. The detailed analysis revealed that of these, 2 had no consultant names whereas 5 were incorrect. The second cycle demonstrated a good improvement with only 1(2.6%) bed-boards having incorrect or no names. The third cycle demonstrated sustainable impact with only 1 (2.6%) missing consultant’s name. Conclusions Ward-rounds have been an age-old practice to review patients and are vital to formulate a care plan for patients, particularly in acute settings. It is also important for the patient to know who is providing their care. Wrong or missing entries could compromise patient care and has implications in patient follow up and chasing results. A simple intervention by the nursing and medical staff can improve the quality of care.
Appropriate planning, execution, and reporting of statistical methods and results is critical for research transparency, validity, and reproducibility. This paper provides an overview of best practices for developing a statistical analysis plan a priori, conducting statistical analyses, and reporting statistical methods and results for human nutrition randomized controlled trials (RCTs). Readers are referred to the other NURISH (NUtrition inteRventIon reSearcH) publications for detailed information about the preparation and conduct of human nutrition RCTs. Collectively, the NURISH series outlines best practices for conducting human nutrition research.
Abstract Aim The administration of intravesical chemotherapy (IVCT) following transurethral resection of bladder tumour (TURBT) has been shown to decrease the risk of recurrence and is recommended as standard practice following TURBT for new & recurrent tumours. Our aim was to evaluate the adherence to this guideline in our trust and if needed, to implement changes in order to improve the patient care. Method A retrospective analysis of 25 patients was done and details regarding the time interval between administration, demographic details and disease staging was collected. NICE guidelines were later implemented, and the data was recollected for 24 patients who underwent TURBT Results The analysis showed that the mean time between the end point of TURBT and instillation of Intravesicular Mitomycin-C was 7.66 hours. Thereafter, we tried to implement the guidelines by improving communication between the Theatre staff, Nursing staff and the pharmacy. The data was collected for re-audit for 24 patients and it was observed that the interval between surgery and Mitomycin administration had dropped down to 4.67 hours. The 3rd cycle of the audit revealed the interval dropping down further to 4.24hours.The 24hr administration rate was >90%, which was much higher than previous year audits Conclusions Engagement with theatre team and pharmacy is required, in order to coordinate the delivery of the IVCT to theatre for administration at the time of surgery. If everyone (hospital pharmacy and theatre staff) is supportive, patients’ quality of care can be improved by following the standardised protocol.
In human nutrition randomized controlled trials (RCTs), planning, and careful execution of clinical data collection and management are vital for producing valid and reliable results. In this article, we provide an overview of best practices for biospecimen collection and analyses, and for the fundamentals of clinical data management, including preparation and study startup; data collection, entry, cleaning, and authentication; and database lock. The reader is also referred to additional resources for information to assist in the planning and conduct of human RCTs. The tools and strategies described are expected to improve the quality of data produced in human nutrition research that can, therefore, be used to support food and nutrition policies.
OBJECTIVE:Menopause represents a period in which bone deterioration is accelerated; thus, primary prevention strategies to address age-related bone loss are crucial. Dairy products contain more than a dozen essential nutrients, including calcium, phosphorus, vitamin D, and high-quality protein, as well as bioactive compounds that may promote bone mineralization. However, the relationship between dairy consumption and bone health across the menopause transition remains largely unknown. The purpose of this analysis was to estimate the change in lumbar spine and femoral neck bone mineral density and the risk of bone fracture by the frequency of dairy intakes among women across the menopausal transition using the publicly available data from the Study of Women's Health Across the Nation. METHODS:We analyzed total dairy foods in four categories of <0.5, 0.5 to <1.5, 1.5 to <2.5, and ≥2.5 servings/d or <1.5 and ≥1.5 servings/d. A general linear model was used to estimate the association of dairy intake with the 10-year bone mineral density loss rate and a linear mixed model was used to estimate the annualized bone mineral density loss rate of the femoral neck and lumbar spine. A Cox proportional hazard model was applied to calculate hazard ratios and 95% confidence intervals of the nontraumatic fractures. Poisson regression was used to determine the relative risks and 95% confidence intervals of the nontraumatic fractures. The models were controlled for race/ethnicity, age, height, weight, smoking status, physical activity, alcohol consumption, calcium use, menopausal status, and total caloric intake. RESULTS:No significant differences in bone mineral density change were observed, regardless of baseline menopausal status. No significant differences in the risk of nontraumatic fracture were observed. CONCLUSIONS:In this group of US women undergoing the menopausal transition, dairy food intake was neither associated with femoral and spine bone mineral density loss nor the risk of fractures.
OBJECTIVE The objective of this study was to assess the agreement between estimated 24-hour urinary sodium excretion (e24hUNa) and estimated 24-hour urinary potassium excretion (e24hUK), calculated from a spot urine sample using several available equations and actual sodium and potassium intake from a controlled diet in both healthy participants and those with chronic kidney disease (CKD). DESIGN AND METHODS This study is a secondary analysis of a controlled feeding study in CKD patients matched to healthy controls. Participants (n = 16) consumed the controlled diet, which provided ∼2400 mg Na/day and ∼3000 mg K/day, for 8 days. On days 7 and 8, participants consumed all meals and collected all urine in an inpatient research setting, and they were discharged on day 9. The day 7 morning spot urine sample was used to calculate e24hUNa and e24hUK, which was compared with known sodium and potassium intake, respectively. RESULTS Average e24hUNa from the INTERSALT and Tanaka-Na equations were higher than actual sodium intake by 373 mg and 559 mg, respectively, though the differences were not significant. e24hUNa from the Nerbass-SALTED equation in CKD participants was significantly higher than actual sodium intake by ∼2000 mg (P < .001), though e24hUNa from the Nerbass-RRID equation was not different from intake. e24hUK from the Tanaka-K equation was significantly lower than actual potassium intake (P < .001). For both e24hUNa and e24hUK for all participants, agreement with actual intake was poor, and e24hUNa and e24hUK were not correlated with actual sodium or potassium intake, respectively. CONCLUSION e24hUNa and e24hUK are poor indicators of true sodium and potassium intake, respectively, in both healthy and CKD participants. Findings should be confirmed in larger sample sizes with varying levels of dietary sodium and potassium.
ABSTRACT There is an unmet need for interventions with better compliance that prevent the adverse effects of sex steroid deficiency on the musculoskeletal system. We identified a blueberry cultivar (Montgomerym [Mont]) that added to the diet protects female mice from musculoskeletal loss and body weight changes induced by ovariectomy. Mont, but not other blueberries, increased the endogenous antioxidant response by bypassing the traditional antioxidant transcription factor Nrf2 and without activating estrogen receptor canonical signaling. Remarkably, Mont did not protect the male skeleton from androgen-induced bone loss. Moreover, Mont increased the variety of bacterial communities in the gut microbiome (α-diversity) more in female than in male mice; shifted the phylogenetic relatedness of bacterial communities (β-diversity) further in females than males; and increased the prevalence of the taxon Ruminococcus1 in females but not males. Therefore, this nonpharmacologic intervention (i) protects from estrogen but not androgen deficiency; (ii) preserves bone, skeletal muscle, and body composition; (iii) elicits antioxidant defense responses independently of classical antioxidant/estrogenic signaling; and (iv) increases gut microbiome diversity toward a healthier signature. These findings highlight the impact of nutrition on musculoskeletal and gut microbiome homeostasis and support the precision medicine principle of tailoring dietary interventions to patient individualities, like sex. © 2020 American Society for Bone and Mineral Research (ASBMR).