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Abstract Background Associations of dietary sodium and potassium intake with fracture risk are inconsistent and the effects of salt substitute on fracture incidence are unknown. We assessed the effect of salt substitute compared to regular salt intake on fracture incidence using data from the Salt Substitute and Stroke Study (SSaSS). Methods SSaSS was a cluster-randomized controlled trial conducted in 600 villages in northern China. Villages were randomly allocated into intervention and control groups in a 1:1 ratio. Salt substitute was provided to intervention villages and control villages continued regular salt use for 5 years. The primary outcome for this secondary analysis was the incidence of all fractures. Secondary outcomes included incidence of vertebral fracture, non-vertebral fracture, and fracture of unknown or non-specific location. Results 20,995 participants were included in this study, and 821 fractures occurred during follow-up. Intention-to-treat analyses showed no differences between the salt substitute and regular salt groups in the incidence of all fractures (rate ratio (RR) 0.96; 95% CI 0.81 to 1.14), vertebral fracture (RR 0.82; 95% CI 0.53 to 1.26), non-vertebral fracture (RR 1.05; 95% CI 0.86 to 1.29), or fracture of unknown or non-specific location (RR 0.80; 95% CI 0.54 to 1.18). Conclusions Use of salt substitute compared to regular salt had no detectable effect on the incidence of fracture in a population at high risk of cardiovascular disease and fracture. Trial registration ClinicalTrials.gov, NCT02092090. Registered on March 12, 2014.

Background: Potassium-enriched salt is a proven dietary intervention for reducing risk of stroke, cardiovascular disease, and premature mortality when used instead of regular table salt. Potassium-enriched salt products are available globally, but the on-pack health claims, product features, and instructions for use are diverse. Objectives: The objective of this study was to summarize the label features of potassium-enriched salt products available worldwide. Methods: A content analysis was conducted on the labels of potassium-enriched salt products available for sale in May 2023. Potassium-enriched salt products were identified through a systematic search of literature, major online shopping websites, and Google using similar keywords such as “salt substitute” or “low sodium salt.” Information on product labels was coded relating to health claims, product features, and instructions for use, and were quantitatively summarized. Results: A total of 117 potential potassium-enriched salt products were identified, with 83 included in the final analysis after excluding products containing no sodium (n = 15), no potassium (n = 5), or that were duplicates (n = 14). There were 23 (28%) products with on-pack claims for health benefits and 36 (43%) with health warnings. Twenty-five (30%) of product labels included descriptions of other product features such as taste and potassium content, and 36 (43%) had instructions for use. Conclusions: There was large variability in the label features of potassium-enriched salt products identified in this study. Most product labels made no health-related statements, but among those that did, warnings occurred more frequently than statements of health benefits. The diversity in labeling may cause confusion among consumers, and standardized, evidence-based labeling should be developed.

Meat-based foods have significant environmental impacts that are lower for plant-based meat alternatives. Fungi-based mycoprotein offers another alternative to meat, but its comparative environmental impacts have not been comprehensively reviewed. We identified life cycle assessments (LCAs) of mycoprotein-based meat alternatives using ProQuest, Scopus and Web of Science, and the grey literature. Studies were included if they were published in the English language from 1 January 2013 until 18 September 2023, reported process-based LCAs with functional units by product weight, and reported any environmental impact measure, system boundary, or region. Data for mycoprotein was compared against plant-based meat alternatives for base-protein, burgers, mince and sausages, and against meats. Five LCAs of mycoprotein-based products were identified. Greenhouse gas emissions (GHGe) were lower for mycoprotein (0.73 kgCO2eq/kg) compared to soy (1.21 kgCO2eq/kg) or pea protein concentrate (1.91 kgCO2eq/kg). GHGe for mycoprotein-based product types were lower than or comparable to equivalent plant-based products, and lower compared to meat. GHGe from the ingredient production stage were generally lower for mycoprotein-based products compared to plant-based products. Further data are needed to compare land use and water scarcity impacts. Mycoprotein offers clear environmental advantages over meat, but distinctions between mycoprotein and plant-based alternatives require more comprehensive data.

Abstract Background The findings from multi-centre trials are central to the practice of evidence-based medicine, enabling the development and implementation of new treatments. The time it takes to commence clinical trials at sites can be long, and ethics and governance approvals are key steps on the pathway to site activation. The goal of this study was to explore factors influencing the times to ethics approval, governance approval and site activation for multi-centre clinical trials. Methods This paper assessed the associations of trial characteristics (disease area and trial phase), site characteristics (government or private ownership, country) and characteristics of the ethics and governance processes (scope guidelines, mutual acceptance requirements and triage of projects by risk) with times to approvals and activation. Median times were compared between site initiations that were and were not exposed to each characteristic using non-parametric tests in univariable and multivariable regressions. Results There were data from 150 site activations done across 91 sites, 16 trials and 5 countries from November 2013 to November 2021. The overall median time to activation was 234 days (range 74 to 657), with ethics approval taking a median of 48 days (0 to 369) and governance approval a median of 34 days (0 to 489). Both the univariable and multivariable analyses identified associations of disease area, particularly oncology (p univariable = 0.012, p multivariable = 0.044), use of scope guidelines (p 0.054). The only factors associated with reduced overall time to site activation in both univariable and multivariable analyses were the early trial phase (p

Abstract Objective: In 2015, the Victorian Salt Reduction Partnership launched a 4-year multifaceted salt reduction intervention designed to reduce salt intake by 1 g/d in children and adults living in Victoria, Australia. Child-relevant intervention strategies included a consumer awareness campaign targeting parents and food industry engagement seeking to reduce salt levels in processed foods. This study aimed to assess trends in salt intake, dietary sources of salt and discretionary salt use in primary schoolchildren pre- and post-delivery of the intervention. Design: Repeated cross-sectional surveys were completed at baseline (2010–2013) and follow-up (2018–2019). Salt intake was measured via 24-h urinary Na excretion, discretionary salt use behaviours by self-report and sources of salt by 24-h dietary recall. Data were analysed with multivariable-adjusted regression models. Setting: Victoria, Australia. Participants: Children aged 4–12 years Results: Complete 24-h urine samples were collected from 666 children at baseline and 161 at follow-up. Mean salt intake remained unchanged from baseline (6·0; se 0·1 g/d) to follow-up (6·1; 0·4 g/d) (P = 0·36), and there were no clear differences in the food sources of salt and at both time points approximately 70 % of children exceeded Na intake recommendations. At follow-up, 14 % more parents (P = 0·001) reported adding salt during cooking, but child use of table salt and inclusion of a saltshaker on the table remained unchanged. Conclusion: These findings show no beneficial effect of the Victorian Salt Reduction Partnership intervention on children’s salt intake. More intensive, sustained and coordinated efforts between state and federal stakeholders are required.

Abstract Background The Victorian Salt Reduction Partnership (VSRP) implemented a media advocacy strategy (intervention) to stimulate food manufacturers to reduce sodium levels across targeted Australian packaged foods between 2017 and 2019. This study assessed changes in sodium levels of targeted and non-targeted packaged foods during the intervention (2017 to 2019) compared to before the intervention (2014 to 2016) in Australia. Methods Annually collected branded-food composition data from 2014 to 2019 were used. Interrupted time series analyses was conducted to compare the trend in sodium levels in packaged foods during the intervention (2017–2019) to the trend in the pre-intervention period (2014–2016). The difference between these trends was derived to estimate the effect of the intervention. Results A total of 90,807 products were included in the analysis, of which 14,743 were targeted by the intervention. The difference in before and during intervention trends between targeted and non-targeted food categories was 2.59 mg/100 g (95% CI: -13.88 to 19.06). There was a difference in the pre-intervention slope (2014, 2015, 2016) and intervention slope (2017, 2018, 2019) for four of 17 targeted food categories. There was a decrease in sodium levels (mg/100 g) in one food category: frozen ready meals (-13.47; 95% CI: -25.40 to -1.53), and an increase in three categories: flat bread (20.46; 95% CI: 9.11 to 31.81), plain dry biscuits (24.53; 95% CI: 5.87 to 43.19), and bacon (44.54; 95% CI: 6.36 to 82.72). For the other 13 targeted categories, the difference in slopes crossed the line of null effect. Conclusions The VSRP’s media advocacy strategy did not result in a meaningful reduction in sodium levels of targeted packaged food products during the intervention years compared to trends in sodium levels before the intervention. Our study suggests media advocacy activities highlighting the differences in sodium levels in packaged food products and industry meetings alone are not sufficient to lower average sodium levels in packaged foods in the absence of government leadership and measurable sodium targets.

Abstract Objective: Switching regular salt (sodium chloride) to salt enriched with potassium chloride (25 % potassium chloride, 75 % sodium chloride) has been shown to reduce blood pressure and the risk of cardiovascular diseases. We sought to define the potential for the current production of sodium chloride and potassium chloride to support a global switch to the use of potassium-enriched salt. Design: We summarised data from geological surveys, government reports and trade organisations describing the global production and supply of sodium chloride and potash (the primary source of potassium chloride) and compared this to potential requirements for potassium-enriched salt. Setting: Global. Participants: Not applicable. Results: Approximately 280 million tonnes of sodium chloride were produced in 2020 with China and the USA the main producers. Global production of potash from which potassium chloride is extracted was about forty-four million tonnes with Canada, Belarus, Russia and China providing 77 % of the world’s supply. There were forty-eight countries in which potassium-enriched salt is currently marketed with seventy-nine different brands identified. Allowing for loss of salt between manufacture and consumption, a full global switch from regular salt to potassium-enriched salt would require about 9·7 million tonnes of sodium chloride to be replaced with 9·7 million tonnes of potassium chloride annually. Conclusions: Significant upscaling of the production of potassium chloride and the capacity of companies able to manufacture potassium-enriched salt, as well as a robust business case for the switch to potassium chloride, would be required.

Abstract Background Consumption of ultra-processed foods is associated with increased risk of obesity and non-communicable diseases. Little is known about current patterns of ultra-processed foods intake in Australia. The aim of this study was to examine the amount and type of ultra-processed foods purchased by Australian households in 2019 and determine whether purchases differed by socio-economic status (SES). We also assessed whether purchases of ultra-processed foods changed between 2015 and 2019. Methods We used grocery purchase data from a nationally representative consumer panel in Australia to assess packaged and unpackaged grocery purchases that were brought home between 2015 to 2019. Ultra-processed foods were identified according to the NOVA system, which classifies foods according to the nature, extent and purpose of industrial food processing. Purchases of ultra-processed foods were calculated per capita, using two outcomes: grams/day and percent of total energy. The top food categories contributing to purchases of ultra-processed foods in 2019 were identified, and differences in ultra-processed food purchases by SES (Index of Relative Social Advantage and Disadvantage) were assessed using survey-weighted linear regression. Changes in purchases of ultra-processed foods between 2015 to 2019 were examined overall and by SES using mixed linear models. Results In 2019, the mean ± SD total grocery purchases made by Australian households was 881.1 ± 511.9 g/d per capita. Of this, 424.2 ± 319.0 g/d per capita was attributable to purchases of ultra-processed foods, which represented 56.4% of total energy purchased. The largest food categories contributing to total energy purchased included mass-produced, packaged breads (8.2% of total energy purchased), chocolate and sweets (5.7%), biscuits and crackers (5.7%) and ice-cream and edible ices (4.3%). In 2019, purchases of ultra-processed foods were significantly higher for the lowest SES households compared to all other SES quintiles (P

Abstract Background Enhanced de-novo collagen type VI (COL VI) formation has been associated with kidney and cardiovascular fibrosis. We hypothesized that endotrophin (ETP), a product specifically generated during collagen type VI formation, may be prognostic for heart failure (HF), cardiovascular death (CVD), kidney endpoints, and all-cause mortality in patients with type 2 diabetes. Methods We measured ETP in plasma (P-ETP) and urine (U-ETP) samples collected at baseline and follow-up (year 3) from the randomized controlled trial, CANagliflozin cardioVascular Assessment Study (CANVAS), by use of the PRO-C6 ELISA measuring COL VI formation and ETP. At baseline, plasma and urine samples were available for 3531 and 3423 patients, respectively. At year 3, plasma and urine samples were available for 2178 (61.7%) and 2070 (60.5%) patients, respectively Patients were followed for a median of 6.1 years, and endpoints included: incident HF, CVD, three kidney composite endpoints, and all-cause mortality. Backward selection was used to identify variables to be included in the analyses. Robustness of the association with outcome was assessed by bootstrap analyses. Results In univariable analysis, P-ETP predicted all investigated outcomes (all p

Abstract Background Sodium glucose co-transporter-2 (SGLT2) inhibitors reduce the risk of kidney and heart failure events independent of glycemic effects. We assessed whether initiation of the SGLT2 inhibitor canagliflozin guided by multivariable predicted risk based on clinical characteristics and novel biomarkers is more efficient to prevent clinical outcomes compared to a strategy guided by HbA1c or urinary-albumin-creatinine ratio (UACR) alone. Methods We performed a post-hoc analysis of the CANVAS trial including 3713 patients with available biomarker measurements. We compared the number of composite kidney (defined as a sustained 40% decline in eGFR, chronic dialysis, kidney transplantation, or kidney death) and composite heart failure outcomes (defined as heart failure hospitalization or cardiovascular (CV) death) prevented per 1000 patients treated for 5 years when canagliflozin was initiated in patients according to HbA1c ≥ 7.5%, UACR, or multivariable risk models consisting of: (1) clinical characteristics, or (2) clinical characteristics and novel biomarkers. Differences in the rates of events prevented between strategies were tested by Chi2-statistic. Results After a median follow-up of 6.1 years, 144 kidney events were recorded. The final clinical model included age, previous history of CV disease, systolic blood pressure, UACR, hemoglobin, body weight, albumin, estimated glomerular filtration rate, and randomized treatment assignment. The combined biomarkers model included all clinical characteristics, tumor necrosis factor receptor-1, kidney injury molecule-1, matrix metallopeptidase-7 and interleukin-6. Treating all patients with HbA1c ≥ 7.5% (n = 2809) would prevent 33.0 (95% CI 18.8 to 43.3 ) kidney events at a rate of 9.6 (95% CI 5.5 to 12.6) events prevented per 1000 patients treated for 5 years. The corresponding rates were 5.8 (95% CI 3.4 to 7.9), 16.6 (95% CI 9.5 to 22.0) (P < 0.001 versus HbA1c or UACR approach), and 17.5 (95% CI 10.0 to 23.0) (P < 0.001 versus HbA1c or UACR approach; P = 0.54 versus clinical model). Findings were similar for the heart failure outcome. Conclusion Initiation of canagliflozin based on an estimated risk-based approach prevented more kidney and heart failure outcomes compared to a strategy based on HbA1c or UACR alone. There was no apparent gain from adding novel biomarkers to the clinical risk model. These findings support the use of risk-based assessment using clinical markers to guide initiation of SGLT2 inhibitors in patients with type 2 diabetes.

Background Sodium glucose cotransporter‐2 inhibitors reduce systolic blood pressure (SBP), but whether they affect SBP variability is unknown. There also remains uncertainty regarding the prognostic value of SBP variability for different clinical outcomes. Methods and Results Using individual participant data from the CANVAS (Canagliflozin Cardiovascular Assessment Study) Program and CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial, we assessed the effect of canagliflozin on SBP variability in people with type 2 diabetes across 4 study visits over 1.5 years as measured by standard deviation, coefficient of variation, and variability independent of the mean. We used multivariable Cox regression models to estimate associations of SBP variability with cardiovascular, kidney, and mortality outcomes. In 11 551 trial participants, canagliflozin modestly lowered the standard deviation of SBP variability (−0.25 mm Hg [95% CI, –0.44 to −0.06]), but there was no effect on coefficient of variation (0.02% [95% CI, –0.12 to 0.16]) or variability independent of the mean (0.08 U [95% CI, –0.11 to 0.26]) when adjusting for correlation with mean SBP. Each 1 standard deviation increase in standard deviation of SBP variability was independently associated with higher risk of hospitalization for heart failure (hazard ratio [HR], 1.19 [95% CI, 1.02–1.38]) and all‐cause mortality (HR, 1.12 [95% CI, 1.01–1.25]), with consistent results observed for coefficient of variation and variability independent of the mean. Increases in SBP variability were not associated with kidney outcomes. Conclusions In people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease, higher visit‐to‐visit SBP variability is independently associated with risks of hospitalization for heart failure and all‐cause mortality. Canagliflozin has little to no effect on SBP variability, independent of its established SBP‐lowering effect. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01032629, NCT01989754, NCT02065791.

BackgroundDietary sodium has a dose-response relationship with cardiovascular disease, and sodium intake in Sweden exceeds national and international recommendations. Two thirds of dietary sodium intake comes from processed foods, and adults in Sweden eat more processed foods than any other European country. We hypothesized that sodium content in processed foods is higher in Sweden than in other countries. The aim of this study was to investigate sodium content in processed food items in Sweden, and how it differs from Australia, France, Hong Kong, South Africa, the United Kingdom and the United States.MethodsData were collected from retailers by trained research staff using standardized methods. Data were categorized into 10 food categories and compared using Kruskal-Wallis test of ranks. Sodium content in the food items was compared in mg sodium per 100 g of product, based on the nutritional content labels on the packages.ResultsCompared to other countries, Sweden had among the highest sodium content in the “dairy” and “convenience foods” categories, but among the lowest in “cereal and grain products,” “seafood and seafood products” and “snack foods” categories. Australia had the overall lowest sodium content, and the US the overall highest. The highest sodium content in most analyzed countries was found in the “meat and meat products” category. The highest median sodium content in any category was found among “sauces, dips, spreads and dressings” in Hong Kong.ConclusionThe sodium content differed substantially between countries in all food categories, although contrary to our hypothesis, processed foods overall had lower sodium content in Sweden than in most other included countries. Sodium content in processed food was nonetheless high also in Sweden, and especially so in increasingly consumed food categories, such as “convenience foods”.

Abstract Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including simplifying the ethics review and governance process of clinical trials. This study’s objective was to systematically review the effects of government actions targeting ethics reviews or governance processes on clinical trial activity. The data sources of Pub Med, Scopus, Sage, ProQuest, Google, Google Scholar and reference lists were all searched between 9/8/20 and 6/9/20. From these sources, 1455 potentially eligible reports were reviewed and full text assessments were done for 295. Thirty-eight reports provided data on 45 interventions—13 targeting ethics review and 32 targeting governance processes—were included. There were data describing effects on a primary or secondary outcome (the number of clinical trials or expenditure on clinical trials) for 39/45 of the interventions. 23/39 (59%) reported positive effects, meaning a greater number of trials and/or expenditure on clinical trials (6/11 ethics, 17/28 governance), 7/39 (18%) reported null effects (4/11 ethics, 3/28 governance) and 9/39 (23%) reported adverse effects (1/13 ethics, 8/28 governance). Positive effects were attributable to interventions that better defined the scope of review, placed clear expectations on timelines or sought to achieve mutual acceptance of ethics review outcomes. Adverse effects were mostly caused by governance interventions that unintentionally added an extra layer of bureaucracy or were developed without full consideration of the broader clinical trial approval system. Governments have an opportunity to enhance clinical trial activity with interventions targeting ethics reviews and governance processes but must be aware that some interventions can have an adverse impact.

Introduction Relationships between glycemic-lowering effects of sodium glucose co-transporter 2 inhibitors and impact on kidney and cardiovascular outcomes are uncertain.Research design and methods We analyzed 4395 individuals with prebaseline and postbaseline hemoglobin A1c (HbA1c) randomized to canagliflozin (n=2193) or placebo (n=2202) in The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation trial. Effects on HbA1c were assessed using mixed models. Mediation of treatment effects by achieved glycemic control was analyzed using proportional hazards regression with and without adjustment for achieved HbA1c. End points included combined kidney or cardiovascular death, end-stage kidney disease or doubling of serum creatinine (primary trial outcome), and individual end point components.Results HbA1c lowering was modified by baseline estimated glomerular filtration rate (eGFR). For baseline eGFR 60–90, 45–59, and 30–44 mL/min/1.73 m2, overall HbA1c (canagliflozin vs placebo) decreased by −0.24%, −0.14%, and −0.08% respectively and likelihood of >0.5% decrease in HbA1c decreased with ORs of 1.47 (95% CI 1.27 to 1.67), 1.12 (0.94 to 1.33) and 0.99 (0.83 to 1.18), respectively. Adjustment for postbaseline HbA1c marginally attenuated canagliflozin effects on primary and kidney composite outcomes: unadjusted HR 0.67 (95% CI 0.57 to 0.80) and 0.66 (95% CI 0.53 to 0.81); adjusted for week 13 HbA1c, HR 0.71 (95% CI 0.060 to 0.84) and 0.68 (95% CI 0.55 to 0.83). Results adjusted for time-varying HbA1c or HbA1c as a cubic spline were similar and consistent with preserved clinical benefits across a range of excellent and poor glycemic control.Conclusions The glycemic effects of canagliflozin are attenuated at lower eGFR but effects on kidney and cardiac end points are preserved. Non-glycemic effects may be primarily responsible for the kidney and cardioprotective benefits of canagliflozin.22

BackgroundEven modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category; and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor. ObjectiveOur aim was to determine whether a 12-week intervention with a sodium-reduction package comprising the SaltSwitch smartphone app and an RSS could reduce urinary sodium excretion in adults with high BP. MethodsA 2-arm parallel randomized controlled trial was conducted in New Zealand (target n=326). Following a 2-week baseline period, adults who owned a smartphone and had high BP (≥140/85 mm Hg) were randomized in a 1:1 ratio to the intervention (SaltSwitch smartphone app + RSS) or control (generic heart-healthy eating information from The Heart Foundation of New Zealand). The primary outcome was 24-hour urinary sodium excretion at 12 weeks estimated via spot urine. Secondary outcomes were urinary potassium excretion, BP, sodium content of food purchases, and intervention use and acceptability. Intervention effects were assessed blinded using intention-to-treat analyses with generalized linear regression adjusting for baseline outcome measures, age, and ethnicity. ResultsA total of 168 adults were randomized (n=84, 50% per group) between June 2019 and February 2020. Challenges associated with the COVID-19 pandemic and smartphone technology detrimentally affected recruitment. The adjusted mean difference between groups was 547 (95% CI −331 to 1424) mg for estimated 24-hour urinary sodium excretion, 132 (95% CI −1083 to 1347) mg for urinary potassium excretion, −0.66 (95% CI −3.48 to 2.16) mm Hg for systolic BP, and 73 (95% CI −21 to 168) mg per 100 g for the sodium content of food purchases. Most intervention participants reported using the SaltSwitch app (48/64, 75%) and RSS (60/64, 94%). SaltSwitch was used on 6 shopping occasions, and approximately 1/2 tsp per week of RSS was consumed per household during the intervention. ConclusionsIn this randomized controlled trial of a salt-reduction package, we found no evidence that dietary sodium intake was reduced in adults with high BP. These negative findings may be owing to lower-than-anticipated engagement with the trial intervention package. However, implementation and COVID-19–related challenges meant that the trial was underpowered, and it is possible that a real effect may have been missed. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12619000352101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377044 and Universal Trial U1111-1225-4471

Summary: Background: The worldwide control rate for hypertension is dismal. An inadequate number of physicians to treat patients with hypertension is one key obstacle. Innovative health system approaches such as delegation of basic tasks to non-physician health workers (task-sharing) might alleviate this problem. Massive scale up of population-wide hypertension management is especially important for low- and middle-income countries such as India. Methods: Using constrained optimization models, we estimated the hypertension treatment capacity and salary costs of staff involved in hypertension care within the public health system of India and simulated the potential effects of (1) an increased workforce, (2) greater task-sharing among health workers, and (3) extended average prescription periods that reduce treatment visit frequency (e.g., quarterly instead of monthly). Findings: Currently, only an estimated 8% (95% uncertainty interval 7%–10%) of ∼245 million adults with hypertension can be treated by physician-led services in the Indian public health system (assuming the current number of health workers, no greater task-sharing, and monthly visits for prescriptions). Without task-sharing and with continued monthly visits for prescriptions, the least costly workforce expansion to treat 70% of adults with hypertension would require ∼1.6 (1.0–2.5) million additional staff (all non-physicians), with ∼INR 200 billion (≈USD 2.7 billion) in additional annual salary costs. Implementing task-sharing among health workers (without increasing the overall time on hypertension care) or allowing a 3-month prescription period was estimated to allow the current workforce to treat ∼25% of patients. Joint implementation of task-sharing and a longer prescription period could treat ∼70% of patients with hypertension in India. Interpretation: The combination of greater task-sharing and extended prescription periods could substantially increase the hypertension treatment capacity in India without any expansion of the current workforce in the public health system. By contrast, workforce expansion alone would require considerable, additional human and financial resources. Funding: Resolve to Save Lives, an initiative of Vital Strategies, was funded by grants from Bloomberg Philanthropies; the Bill and Melinda Gates Foundation; and Gates Philanthropy Partners (funded with support from the Chan Zuckerberg Foundation).

BackgroundTo reduce excess dietary sodium consumption, Nigeria's 2019 National Multi-sectoral Action Plan (NMSAP) for the Prevention and Control of Non-communicable Diseases includes policies based on the World Health Organization SHAKE package. Priority actions and strategies include mandatory sodium limits in processed foods, advertising restrictions, mass-media campaigns, school-based interventions, and improved front-of-package labeling. We conducted a formative qualitative evaluation of stakeholders' knowledge, and potential barriers as well as effective strategies to implement these NMSAP priority actions.MethodsFrom January 2021 to February 2021, key informant interviews (n = 23) and focus group discussions (n = 5) were conducted with regulators, food producers, consumers, food retailers and restaurant managers, academia, and healthcare workers in Nigeria. Building on RE-AIM and the Consolidated Framework for Implementation Research, we conducted directed content qualitative analysis to identify anticipated implementation outcomes, barriers, and facilitators to implementation of the NMSAP sodium reduction priority actions.ResultsMost stakeholders reported high appropriateness of the NMSAP because excess dietary sodium consumption is common in Nigeria and associated with high hypertension prevalence. Participants identified multiple barriers to adoption and acceptability of implementing the priority actions (e.g., poor population knowledge on the impact of excess salt intake on health, potential profit loss, resistance to change in taste) as well as facilitators to implementation (e.g., learning from favorable existing smoking reduction and advertising strategies). Key strategies to strengthen NMSAP implementation included consumer education, mandatory and improved front-of-package labeling, legislative initiatives to establish maximum sodium content limits in foods and ingredients, strengthening regulation and enforcement of food advertising restrictions, and integrating nutrition education into school curriculum.ConclusionWe found that implementation and scale-up of the Nigeria NMSAP priority actions are feasible and will require several implementation strategies ranging from community-focused education to strengthening current and planned regulation and enforcement, and improvement of front-of-package labeling quality, consistency, and use.

BackgroundNutrition policies to improve the food environment frequently rely on voluntary business action for implementation, many have had mixed success. The aims of this study were to identify key food system drivers influencing the Australian packaged food sector and analyse how these might impact the willingness of food companies to voluntarily reduce salt in packaged foods. MethodsBusiness methods formed the basis of this retrospective applied policy analysis of voluntary salt reduction for the period 2013-2016 where the focal policy was the Australian Food and Health Dialogue (2009-2015). The analytical framework included political-legal, economic, social, technological (PEST) external drivers of the food system, and Porter’s Five Forces for the competitive drivers of the food system. Documentary data identifying food system drivers affecting the Australian packaged food sector (comprised of the food processing and supermarket industries) were identified through a comprehensive search of the grey and academic literatures. ResultsThe interplay between external and competitive food system drivers created an environment in which voluntary salt reduction was found to be an uneasy fit. A high cost of doing business, soft growth, intense competition, asymmetry of power in favour of supermarkets, and marginal consumer interest in less salty food were found likely to create commercial disincentives to invest in voluntary salt reduction above more pressing commercial imperatives. Analysis of food manufacturing industries highlighted the highly contextual nature of food system drivers. Opportunities for nutrition policy included: support for ‘shared value’ in economic discourse; and, leveraging investor, supermarket, and the largely unrealised bargaining power of consumers. ConclusionBusiness frameworks can provide meaningful insights for nutrition policy on how food system drivers can thwart policy goals. Our analysis highlighted areas to incentivise voluntary action and illustrated the importance of political-legal, economic and consumer strategies for salt reduction.

Abstract Background Multiple observational studies have associated metformin prescription with reduced progression of abdominal aortic aneurysm (AAA). The Metformin Aneurysm Trial (MAT) will test whether metformin reduces the risk of AAA rupture-related mortality or requirement for AAA surgery (AAA events) in people with asymptomatic aneurysms. Methods MAT is an international, multi-centre, prospective, parallel-group, randomised, placebo-controlled trial. Participants must have an asymptomatic AAA measuring at least 35 mm in maximum diameter, no diabetes, no contraindication to metformin and no current plans for surgical repair. The double-blind period is preceded by a 6-week, single-blind, active run-in phase in which all potential participants receive metformin. Only patients tolerating metformin by taking at least 80% of allocated medication will enter the trial and be randomised to 1500 mg of metformin XR or an identical placebo. The primary outcome is the proportion of AAA events defined as rupture-related mortality or need for surgical repair. Secondary outcomes include AAA growth, major adverse cardiovascular events and health-related quality of life. In order to test if metformin reduced the risk of AAA events by at least 25%, 616 primary outcome events will be required (power 90%, alpha 0.05). Discussion Currently, there is no drug therapy for AAA. Past trials have found no convincing evidence of the benefit of multiple blood pressure lowering, antibiotics, a mast cell inhibitor, an anti-platelet drug and a lipid-lowering medication on AAA growth. MAT is one of a number of trials now ongoing testing metformin for AAA. MAT, unlike these other trials, is designed to test the effect of metformin on AAA events. The international collaboration needed for MAT will be challenging to achieve given the current COVID-19 pandemic. If this challenge can be overcome, MAT will represent a trial unique within the AAA field in its large size and design. Trial registration Australian Clinical Trials ACTRN12618001707257 . Registered on 16 October 2018

This article details a correction to: Li J-W, Guo Y-T, Di Tanna GL, Neal B, Chen Y-D, Schutte AE. Vital Signs During the COVID-19 Outbreak: A Retrospective Analysis of 19,960 Participants in Wuhan and Four Nearby Capital Cities in China. Global Heart. 2021;16(1):47. DOI: http://doi.org/10.5334/gh.913.

Abstract Background Countries around the world are putting in place sugar reformulation targets for packaged foods to reduce excess sugar consumption. The Australian government released its voluntary sugar reformulation targets for nine food categories in 2020. We estimated the potential impact of these targets on household sugar purchases and examined differences by income. For comparison, we also modelled the potential impact of the UK sugar reduction targets on per capita sugar purchases as the UK has one of the most comprehensive sugar reduction strategies in the world. Methods Grocery purchase data from a nationally representative consumer panel (n=7,188) in Australia was linked with a large database (FoodSwitch) with product-specific sugar content information for packaged foods (n=25,261); both datasets were collected in 2018. Potential reductions in per capita sugar purchases were calculated overall and by food category. Differences in sugar reduction across income level were assessed by analysis of variance. Results In 2018, the total sugar acquired from packaged food and beverage purchases consumed at-home was 56.1 g/day per capita. Australia’s voluntary reformulation targets for sugar covered 2,471/25,261 (9.8%) unique products in the FoodSwitch dataset. Under the scenario that all food companies adhered to the voluntary targets, sugar purchases were estimated to be reduced by 0.9 g/day per capita, which represents a 1.5% reduction in sugar purchased from packaged foods. However, if Australia adopted the UK targets, over twice as many products would be covered (n=4,667), and this would result in a more than four times greater reduction in sugar purchases (4.1 g/day per capita). It was also estimated that if all food companies complied with Australia’s voluntary sugar targets, reductions to sugar would be slightly greater in low-income households compared with high-income households by 0.3 g/day (95%CI 0.2 - 0.4 g/day, p

Objectives: The potential for using routinely collected data for medical research in China remains unclear. We sought to conduct a scoping review to systematically characterise nation-wide routinely collected datasets in China that may be of value for clinical research.Methods: We searched public databases and the websites of government agencies, and non-government organizations. We included nation-wide routinely collected databases related to communicable diseases, non-communicable diseases, injuries, and maternal and child health. Database characteristics, including disease area, data custodianship, data volume, frequency of update and accessibility were extracted and summarised.Results: There were 70 databases identified, of which 46 related to communicable diseases, 20 to non-communicable diseases, 1 to injury and 3 to maternal and child health. The data volume varied from below 1000 to over 100,000 records. Over half (64%) of the databases were accessible for medical research mostly comprising communicable diseases.Conclusion: There are large quantities of routinely collected data in China. Challenges to using such data in medical research remain with various accessibility. The potential of routinely collected data may also be applicable to other low- and middle-income countries.

Background The sodium‐glucose cotransporter 2 inhibitor canagliflozin reduced the risk of first cardiovascular composite events in the CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) trial. In this post hoc analysis, we evaluated the effect of canagliflozin on total (first and recurrent) cardiovascular events. Methods and Results The CREDENCE trial compared canagliflozin or matching placebo in 4401 patients with type 2 diabetes, albuminuria, and estimated glomerular filtration rate of 30 to

Abstract Aims The CANVAS Program identified the effect of canagliflozin on major adverse cardiovascular events (MACE) differed according to whether participants were using diuretics at study commencement. We sought to further evaluate this finding related to baseline differences, treatment effects, safety, and risk factor changes. Methods and results The CANVAS Program enrolled 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk. Participants were randomized to canagliflozin or placebo and followed for a mean of 188 weeks. The primary outcome was major cardiovascular events, a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included multiple cardiovascular, renal, and safety events. In this post hoc subgroup analysis, participants were categorized according to baseline use of any diuretic. The effect on outcomes was compared using Cox proportional hazards models, while risk factor changes were compared using mixed‐effect models. At baseline, 4490 (44.3%) participants were using a diuretic. Compared with those not using a diuretic, participants using a diuretic were more likely to be older (mean age ± standard deviation, 64.3 ± 8.0 vs. 62.5 ± 8.3), be female (38.9% vs. 33.4%), and have heart failure (19.6% vs. 10.3%) (all Pdifference 0.11), although the effect of canagliflozin on haemoglobin A1c reduction was slightly weaker in participants using compared with not using diuretics at baseline (−0.52% vs. −0.64%, Pheterogeneity = 0.0007). Overall serious adverse events and key safety outcomes, including adverse renal events, were also similar (all Pheterogeneity > 0.07). Conclusions Participants on baseline diuretics derived a greater benefit for major cardiovascular events from canagliflozin, which was not fully explained by differences in participant characteristics nor risk factor changes.

Abstract Background Consumption of nuts improves cardio-metabolic risk factors in clinical trials and relates to lower risk of cardiovascular disease (CVD) in prospective observational studies. However, there has not been an adequately powered randomized controlled trial to test if nuts supplementation actually reduces incident CVD. In order to establish the feasibility of such a trial, the current study aimed to assess the acceptability and adherence to long-term nut supplementation amongst individuals at high CVD risk in China. Methods This protocol described a 6-month trial performed in Ningxia Province in China among participants with a history of CVD or older age (female ≥65 years, male ≥60 years) with multiple CVD risk factors. Participants were randomized to control (received non-edible gift), low dose walnut (30 g/d), or high dose walnut (60 g/d) groups in a 1:1:1 ratio. Walnuts were provided at no cost to participants and could be consumed according to personal preferences. Follow-up visits were scheduled at 2 weeks, 3 months and 6 months. The primary outcome was fasting plasma alpha linolenic acid (ALA) levels used as an indicator of walnut consumption. Secondary outcomes included self-reported walnut intake from the 24 h dietary recalls. The target sample size of 210 provided 90% statistical power with two-sided alpha of 0.05 to detect a mean difference of 0.12% (as percent of total fatty acid) in plasma ALA between randomized groups. Results Two hundred and ten participants were recruited and randomized during October 2019. Mean age of participants was 65 years (SD = 7.3), 47% were females, and 94% had a history of CVD at baseline. Across the three study groups, participants had similar baseline demographic and clinical characteristics. Discussion This trial will quantify acceptability and adherence to long-term walnut supplementation in a Chinese population at high risk of CVD. The findings will support the design of a future large trial to test the effect of walnut supplementation for CVD prevention. Trial registration NCT04037943 Protocol version: v3.0 August 14 2019

Abstract Background The Australian federal government will soon release voluntary sodium reduction targets for 30 packaged food categories through the Healthy Food Partnership. Previous assessments of voluntary targets show variable industry engagement, and little is known about the extent that major food companies and their products contribute to dietary sodium purchases among Australian households. Methods The aim of this cross-sectional study was to identify the relative contribution that food companies and their products made to Australian household sodium purchases in 2018, and to examine differences in sodium purchases by household income level. We used 1 year of grocery purchase data from a nationally representative consumer panel of Australian households who reported their grocery purchases (the Nielsen Homescan panel), combined with database that contains product-specific sodium content for packaged foods and beverages (FoodSwitch). The top food companies and food categories were ranked according to their contribution to household sodium purchases. Differences in per capita sodium purchases by income levels were assessed by 1-factor ANOVA. All analyses were modelled to the Australian population in 2018 using sample weights. Results Sodium data were available from 7188 households who purchased 26,728 unique products and purchased just under 7.5 million food product units. Out of 1329 food companies, the top 10 accounted for 35% of unique products and contributed to 58% of all sodium purchased from packaged foods and beverages. The top three companies were grocery food retailers each contributing 12–15% of sodium purchases from sales of their private label products, particularly processed meat, cheese and bread. Out of the 67 food categories, the top 10 accounted for 73% of sodium purchased, particularly driven by purchases of processed meat (14%), bread (12%) and sauces (11%). Low-income Australian households purchased significantly more sodium from packaged products than high-income households per capita (452 mg/d, 95%CI: 363-540 mg/d, P

ContextGovernments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including targeted direct funding and industry tax rebates. The effectiveness of the different approaches employed is unclear.ObjectiveTo systematically review the effects of direct government financing interventions by allowing companies to reduce their tax payable on clinical trial activity.Data sourcesPub Med, Scopus, Sage, ProQuest, Google Scholar and Google were searched up to the 11th of April 2022. In addition, the reference lists of all potentially eligible documents were hand searched to identify additional reports. Following feedback from co-authors, information on a small number of additional interventions were specifically sought out and included.Data extractionSummary information about potentially eligible reports were reviewed independently by two researchers, followed by extraction of data into a structured spreadsheet for eligible studies. The primary outcomes of interest were the number of clinical trials and the expenditure on clinical trials but data about other evaluations were also collected.ResultsThere were 1694 potentially eligible reports that were reviewed. Full text assessments were done for 304, and 30 reports that provided data on 43 interventions were included- 29 that deployed targeted direct funding and 14 that provided tax rebates or exemptions. There were data describing effects on a primary outcome for 25/41 of the interventions. The most common types of interventions were direct funding to researchers via special granting mechanisms and tax offsets to companies and research organisations. All 25 of the studies for which data were available reported a positive impact on numbers and/or expenditure on clinical trials though the robustness of evaluations was limited for many. Estimates of the magnitude of effects of interventions were reported inconsistently, varied substantially, and could not be synthesised quantitatively, though targeted direct funding interventions appeared to be associated with more immediate impact on clinical trial activity.ConclusionThere is a high likelihood that governments can increase clinical trial activity with either direct or indirect fiscal mechanisms. Direct funding may provide a more immediate and tangible return on investment than tax rebates.

From 2015 to 2020 a state-wide salt-reduction initiative was launched in Victoria, Australia, including an awareness campaign focused on parents with children n = 821 parents; n = 1527 general sample) and post-campaign (2019: n = 935 parents; n = 1747 general sample). KABs were assessed via an online survey. Data were analyzed with regression models and adjusted for covariates. Among parents, around one-quarter of salt-related KABs shifted in a positive direction, but changes were small: there was a 6% (95% CI 2, 11%) increase in the percentage who knew the main source of salt in the diet and reductions in the percentage who reported placing a salt shaker on the table (−8% (95%CI −12, −3)) and that their child added salt at the table (−5% (95% −9, −0.2)). Among the wider adult sample, even fewer shifts in KAB were observed, with some behaviors worsening at follow-up. These findings indicate that this consumer awareness campaign had minimum impact.

Background Studies have suggested that sodium glucose co‐transporter 2 inhibitors exert anti‐inflammatory effects. We examined the association of baseline growth differentiation factor‐15 (GDF‐15), a marker of inflammation and cellular injury, with cardiovascular events, hospitalization for heart failure (HF), and kidney outcomes in patients with type 2 diabetes in the CANVAS (Canagliflozin Cardiovascular Assessment Study) and determined the effect of the sodium glucose co‐transporter 2 inhibitor canagliflozin on circulating GDF‐15. Methods and Results The CANVAS trial randomized 4330 people with type 2 diabetes at high cardiovascular risk to canagliflozin or placebo. The association between baseline GDF‐15 and cardiovascular (non‐fatal myocardial infarction, non‐fatal stroke, cardiovascular death), HF, and kidney (40% estimated glomerular filtration rate decline, end‐stage kidney disease, renal death) outcomes was assessed using multivariable adjusted Cox regression models. During median follow‐up of 6.1 years (N=3549 participants with available samples), 555 cardiovascular, 129 HF, and 137 kidney outcomes occurred. Each doubling in baseline GDF‐15 was significantly associated with a higher risk of cardiovascular (hazard ratio [HR], 1.2; 95% CI, 1.0‒1.3), HF (HR, 1.5; 95% CI, 1.2‒2.0) and kidney (HR, 1.5; 95% CI, 1.2‒2.0) outcomes. Baseline GDF‐15 did not modify canagliflozin’s effect on cardiovascular, HF, and kidney outcomes. Canaglifozin treatment modestly lowered GDF‐15 compared with placebo; however, GDF‐15 did not mediate the protective effect of canagliflozin on cardiovascular, HF, or kidney outcomes. Conclusions In patients with type 2 diabetes at high cardiovascular risk, higher GDF‐15 levels were associated with a higher risk of cardiovascular, HF, and kidney outcomes. Canagliflozin modestly lowered GDF‐15, but GDF‐15 reduction did not mediate the protective effect of canagliflozin.

Increased consumption of unhealthy processed foods, particularly those high in sodium, is a major risk factor for cardiovascular diseases. The nutrition information on packaged foods can help guide consumers toward products with less sodium and support government actions to improve the healthiness of the food supply. The aims of this study were to estimate the proportion of packaged foods displaying nutrition information for sodium and other nutrients specified by Nigerian nutrition labelling regulations and to determine the amount of sodium in packaged foods sold in Nigeria using data from the nutritional information panel. Data were collected from November 2020 to March 2021 from in-store surveys conducted in supermarkets in three states. A total of 7039 products were collected. Overall, 91.5% (n = 6439) provided only partial nutrition information, 7.0% (n = 495) provided no nutritional information, and only 1.5% (n = 105) displayed a nutrient declaration that included all nutrients specified by 2019 Nigerian regulations. Some form of sodium content information was displayed for 86% of all products (n = 6032), of which around 45% (n = 2689) expressed this as ‘salt’ and 59% (n = 3559) expressed this as ‘sodium’, while a small number of food products had both ‘salt’ and ‘sodium’ content (3.6%). Provision of sodium or salt information on the label varied between food categories, ranging from 50% (vitamins and supplements, n = 2/4) to 96% (convenience foods, n = 44/46). Food categories with the highest median sodium content were ‘meat and meat alternatives’ (904 mg/100 g), ‘sauces, dressings, spreads, and dips’ (560 mg/100 g), and ‘snack foods’ (536 mg/100 g), although wide variation was often observed within categories. These findings highlight considerable potential to improve the availability and consistency of nutrition information on packaged products in Nigeria and to introduce further policies to reduce the amount of sodium in the Nigerian food supply.

Background The Australian Government recently established sodium targets for packaged foods to encourage voluntary reformulation to reduce population sodium consumption and related diseases. We modeled the health impact of Australia’s sodium reformulation targets and additional likely health gains if more ambitious, yet feasible sodium targets had been adopted instead. Methods and findings Using comparative risk assessment models, we estimated the averted deaths, incidence, and disability-adjusted life years (DALYs) from cardiovascular disease (CVD), chronic kidney disease (CKD) and stomach cancer after implementation of (a) Australia’s sodium targets (overall and by individual companies); (b) United Kingdom’s targets (that covers more product categories); and (c) an optimistic scenario (sales-weighted 25th percentile sodium content for each food category included in the UK program). We used nationally representative data to estimate pre- and post-intervention sodium intake, and other key data sources from the Global Burden of Disease study. Full compliance with the Australian government’s sodium targets could prevent approximately 510 deaths/year (95% UI, 335 to 757), corresponding to about 1% of CVD, CKD, and stomach cancer deaths, and prevent some 1,920 (1,274 to 2,600) new cases and 7,240 (5,138 to 10,008) DALYs/year attributable to these diseases. Over half (59%) of deaths prevented is attributed to reformulation by 5 market-dominant companies. Compliance with the UK and optimistic scenario could avert approximately an additional 660 (207 to 1,227) and 1,070 (511 to 1,856) deaths/year, respectively, compared to Australia’s targets. The main limitation of this study (like other modeling studies) is that it does not prove that sodium reformulation programs will prevent deaths and disease events; rather, it provides the best quantitative estimates and the corresponding uncertainty of the potential effect of the different programs to guide the design of policies. Conclusions There is significant potential to strengthen Australia’s sodium reformulation targets to improve its health impact. Promoting compliance by market-dominant food companies will be critical to achieving the potential health gains. Kathy Trieu and colleagues model the estimated health impact of sodium reformulation targets in Australia. Author summary Why was this study done? High sodium intake increases blood pressure and the risk of heart disease, chronic kidney disease (CKD), and stomach cancer. Almost all adults in Australia and worldwide exceed sodium intake recommendations. To help reduce population sodium intakes, the Australian Government recently established sodium targets for packaged foods to encourage voluntary reformulation. However, the potential health gains of these targets are not known. What did the researchers do and find? We modeled the potential health gains that could be achieved if all food companies met Australia’s sodium targets and what additional health gains could be achieved if Australia adopted more ambitious targets. Using mathematical models, reductions in population sodium intake after implementation of sodium targets were calculated and translated into expected changes in blood pressure and health gains related to heart disease, CKD, and stomach cancer. Full compliance with Australia’s sodium targets could prevent approximately 510 deaths/year. Over half of these deaths could be prevented by just 5 food companies complying with the targets. If Australia adopted the sodium targets already implemented in the United Kingdom or a more ambitious, yet feasible set of targets, an additional 660 and 1,070 deaths/year, respectively, could be averted. What do these findings mean? This study demonstrates that national sodium reformulation targets could be an effective strategy to prevent death and disability associated with heart disease, CKD, and stomach cancer. Australia’s sodium reformulation targets could achieve greater public health benefits if these targets were mandatory, targeted more food categories, and included more stringent targets. To maximize the potential of Australia’s current sodium targets, promoting full compliance across dominant food companies could help to achieve health gains.

BackgroundChildhood obesity is a major public health issue. The increase in the consumption of foods with poor nutritional value, such as processed foods, contributes to this. Breakfast cereals are often advertised as a healthy way to start the day, but the healthiness of these products varies greatly. ObjectiveOur main objective was to gather information about the nutritional characteristics of ready-to-eat breakfast cereals in Sweden and to investigate the healthiness of products targeted at children compared to other cereals by use of the FoodSwitch platform. A secondary objective was to evaluate the alignment between the Keyhole symbol and the Health Star Rating. MethodsThe FoodSwitch app is a mobile health (mHealth) tool used to present nutrition data and healthier alternative products to consumers. Ready-to-eat breakfast cereals from the largest Swedish grocery retailers were collected using the FoodSwitch platform. Products were defined as targeting children if they presented features addressing children on the package. ResultsOverall, information on 261 ready-to-eat cereals was examined. Of this total, 8% (n=21) were targeted at children. Child-targeted cereals were higher in sugar (22.3 g/100 g vs 12.8 g/100 g, P

BackgroundRegular salt is about 100% sodium chloride. Low-sodium salts have reduced sodium chloride content, most commonly through substitution with potassium chloride. Low-sodium salts have a potential role in reducing the population's sodium intake levels and blood pressure, but their availability in the global market is unknown. ObjectiveThe aim of this study is to assess the availability, formulation, labeling, and price of low-sodium salts currently available to consumers worldwide. MethodsLow-sodium salts were identified through a systematic literature review, Google search, online shopping site searches, and inquiry of key informants. The keywords “salt substitute,” “low-sodium salt,” “potassium salt,” “mineral salt,” and “sodium reduced salt” in six official languages of the United Nations were used for the search. Information about the brand, formula, labeling, and price was extracted and analyzed. ResultsA total of 87 low-sodium salts were available in 47 out of 195 (24%) countries worldwide, including 28 high-income countries, 13 upper-middle-income countries, and 6 lower-middle-income countries. The proportion of sodium chloride varied from 0% (sodium-free) to 88% (as percent of weight; regular salt is 100% sodium chloride). Potassium chloride was the most frequent component with levels ranging from 0% to 100% (potassium chloride salt). A total of 43 (49%) low-sodium salts had labels with the potential health risks, and 33 (38%) had labels with the potential health benefits. The median price of low-sodium salts in high-income, upper-middle-income, and lower-middle-income countries was US $15.00/kg (IQR 6.4-22.5), US $2.70/kg (IQR 1.7-5.5), and US $2.90/kg (IQR 0.50-22.2), respectively. The price of low-sodium salts was between 1.1 and 14.6 times that of regular salts. ConclusionsLow-sodium salts are not widely available and are commonly more expensive than regular salts. Policies that promote the availability, affordability, and labeling of low-sodium salts should increase uptake, helping populations reduce blood pressure and prevent cardiovascular diseases. International Registered Report Identifier (IRRID)RR2-10.1111/jch.14054

Background: The implications of city lockdown on vital signs during the COVID-19 outbreak are unknown. Objective: We longitudinally tracked vital signs using data from wearable sensors and determined associations with anxiety and depression. Methods: We selected all participants in the HUAWEI Heart Study from Wuhan and four nearby large provincial capital cities (Guangzhou, Chongqing, Hangzhou, Zhengzhou) and extracted all data from 26 December 2019 (one month before city lockdown) to 21 February 2020. Sleep duration and quality, daily steps, oxygen saturation and heart rate were collected on a daily basis. We compared the vital signs before and after the lockdown using segmented regression analysis of the interrupted time series. The depression and anxiety cases were defined as scores ≥8 on the Hospital Anxiety and Depression Scale depression and anxiety subscales [HADS-D and HADS-A] in 727 participants who finished the survey. Results: We included 19,960 participants (mean age 36 yrs, 90% men). Compared with pre-lockdown, resting heart rate dropped immediately by 1.1 bpm after city lockdown (95% confidence interval [CI]: –1.8, –0.4). Sleep duration increased by 0.5 hour (95% CI: 0.3, 0.8) but deep sleep ratio decreased by 0.9% (95% CI: –1.2, –0.6). Daily steps decreased by 3352 steps (95% CI: –4333, –2370). Anxiety and depression existed in 26% and 17% among 727 available participants, respectively, and associated with longer sleep duration (0.2 and 0.1 hour, both p < 0.001). Conclusions: Lockdown of Wuhan in China was associated with an adverse vital signs profile (reduced physical activity, heart rate, and sleep quality, but increased sleep duration). Wearable devices in combination with mobile-based apps may be useful to monitor both physical and mental health. Clinical trial registration: The trial is registered at Chinese Clinical Trial Registry (ChiCTR) website (ChiCTR-OOC-17014138).

Abstract Background Patients with type 2 diabetes (T2D) are predisposed to derangements in serum Magnesium (Mg), which may have implications for cardiometabolic events and outcomes. In clinical trials, participants with T2D randomized to sodium‐glucose co‐transporter 2 (SGLT2) inhibitors have shown mild to moderate increases in serum Mg from baseline levels. This post hoc analysis assesses the relation between serum Mg with cardiovascular outcomes in 10,140 participants of the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Methods We evaluated the association of baseline serum Mg with the primary composite end point of death from cardiovascular causes, non‐fatal myocardial infarction, and non‐fatal stroke, and tested whether this association is modified by baseline serum Mg. Using mediation analysis, we determined whether change in serum Mg post‐randomization mediates the beneficial effect of canagliflozin on cardiovascular outcomes. Results Mean serum Mg levels at baseline were 0.77 ± 0.09 mmol/L in both canagliflozin group and placebo groups. The canagliflozin group experienced an average increase in serum Mg by 0.07 mmol/L (95% CI, 0.065–0.072 mmol/L; p

Abstract Objective: The Health Star Rating (HSR) is a front‐of‐pack nutrition labelling system, implemented voluntarily in Australia and New Zealand since 2014. Our aim was to evaluate HSR's performance. Method: We used data from peer‐reviewed publications and government‐commissioned monitoring and evaluation, websites and communiqués to evaluate HSR's performance between June 2014 and October 2018 using the RE‐AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) framework. Results: Thirty‐three peer‐reviewed publications, 21 government and three independent reports informed the assessment. Awareness and trust in HSR was increasing, though campaign reach remained low. Consumers liked, could understand and use the HSR logo, though effects on purchasing were largely unknown. The algorithm was the focus of a formal review. HSR was present on 20–28% of products but biased to those that scored better (HSR≥3.0). Necessary stakeholders were mostly engaged. Conclusions: A substantial body of work supports continuation and strengthening of HSR. Reasonable refinements to HSR's star graphic and algorithm, action to initiate mandatory implementation, and strengthened HSR governance present the clearest opportunities for improving public health impact. Implications for public health: Development and implementation of government‐led front‐of‐pack nutrition labelling systems have the potential to improve public health, while engaging a diverse set of stakeholders.

BackgroundFront-of-pack nutrition labelling (FoPL) of packaged foods can promote healthier diets. Australia and New Zealand (NZ) adopted the voluntary Health Star Rating (HSR) scheme in 2014. We studied the impact of voluntary adoption of HSR on food reformulation relative to unlabelled foods and examined differential impacts for more-versus-less healthy foods.Methods and findingsAnnual nutrition information panel data were collected for nonseasonal packaged foods sold in major supermarkets in Auckland from 2013 to 2019 and in Sydney from 2014 to 2018. The analysis sample covered 58,905 unique products over 14 major food groups. We used a difference-in-differences design to estimate reformulation associated with HSR adoption. Healthier products adopted HSR more than unhealthy products: >35% of products that achieved 4 or more stars displayed the label compared to ConclusionsIn this study, we observed that reformulation changes following voluntary HSR labelling are small, but greater for initially unhealthy products. Initially unhealthy foods were, however, less likely to adopt HSR. Our results, therefore, suggest that mandatory labelling has the greatest potential for improving the healthiness of packaged foods.

Background Several trials have demonstrated protective effects from inhibition of sodium‐glucose cotransporter 2 among patients with type 2 diabetes mellitus. There is uncertainty about the consistency of the cardiovascular benefits achieved across patient subsets. Methods and Results We included 4 large‐scale trials of sodium‐glucose cotransporter 2 inhibition compared with placebo in patients with diabetes mellitus that reported effects on cardiovascular outcomes overall and for participant subgroups defined at baseline by cardiovascular disease, reduced kidney function, and heart failure. Fixed effects models with inverse variance weighting were used to estimate summary hazard ratios and 95% CIs. There were 38 723 patients from 4 trials, with a mean 2.9 years of follow‐up. Of the patients, 22 870 (59%) had cardiovascular disease, 7754 (20%) had reduced kidney function, and 4543 (12%) had heart failure. There were 3828 major adverse cardiac events. There was overall benefit for major adverse cardiac events (0.88; 95% CI, 0.82–0.94; P0.252; I20.302; I20.167; I20.354; I2=0%). The only difference in effects across subgroups was for stroke, with protection observed among those with reduced kidney function but not those with preserved kidney function (P interaction=0.020; I2=81%). Conclusions Sodium‐glucose cotransporter 2 inhibitors protect against cardiovascular disease and death in diverse subsets of patients with type 2 diabetes mellitus regardless of cardiovascular disease history.

Abstract Background The nutritional composition of foods and beverages consumed away from the home has important implications for population health. Our objective was to determine if the serve size, energy, and sodium contents of fast foods sold at chain restaurants in New Zealand (NZ) changed between 2012 and 2016. Methods Serve size and nutrient data were collected in annual cross-sectional surveys of all products sold at 10 major fast food chains. Changes over time may occur due to alterations in product availability or individual product reformulation. Linear regression adjusting for food group and chain was used to estimate overall changes in serve size and nutrients. Random effects mixed models were used to estimate reformulation changes on same products available for two or more years. Results Across all products (n = 5468) increases were observed in mean serve size (+ 9 (3, 15) g, + 5%), energy density (+ 54 (27, 81) kJ/100 g, + 6%), energy per serve (+ 178 (125, 231) kJ, + 14%), and sodium per serve (+ 55 (24, 87) mg, + 12%). Sodium density did not change significantly. Four of 12 food groups (Desserts, Pizza, Sandwiches, and Salads) and four of 10 fast food chains (Domino’s, Hell Pizza, Pizza Hut, and Subway) displayed large, undesirable changes for three or more (of five) outcomes (≥10%; p

Abstract Background This study examined how front-of-pack labels and product healthfulness affect choice and willingness to pay across a range of foods. It was hypothesized that: (i) product choice and (ii) willingness to pay would be more aligned with product healthfulness when healthfulness was expressed through the Health Star Rating, followed by the Multiple Traffic Light, then the Daily Intake Guide, and (iii) the Nutrition Facts Panel would be viewed infrequently. Methods Adults and children aged 10+ years (n = 2069) completed an online discrete choice task involving mock food packages. A 4 food type (cookies, corn flakes, pizza, yoghurt) × 2 front-of-pack label presence (present, absent) × 3 front-of-pack label type (Daily Intake Guide, Multiple Traffic Light, Health Star Rating) × 3 price (cheap, moderate, expensive) × 3 healthfulness (less healthy, moderately healthy, healthier) design was used. A 30 s time limit was imposed for each choice. Results Of the three front-of-pack labels tested, the Health Star Rating produced the largest differences in choices, with 40% (95% CIs: 38%-42%) of respondents selecting the healthier variant, 33% selecting the moderately healthy variant (95% CIs: 31%-35%), and 23% (95% CIs: 21%-24%) selecting the less healthy variant of the four products included in the study. The Multiple Traffic Light led to significant differences in choices between healthier (35%, 95% CIs: 33%-37%) and less healthy products (29%, 95% CIs: 27%-31%), but not moderately healthy products (32%, 95% CIs: 30%-34%). No significant differences in choices were observed by product healthfulness when the Daily Intake Guide was present. Only the Health Star Rating resulted in a significantly greater willingness to pay for healthier versus less healthy products. The Nutrition Facts Panel was viewed for only 7% of all mock packages. Conclusions Front-of-pack labels that are more interpretive, such as the Health Star Rating, can be more effective at directing consumers towards healthier choices than reductive front-of-pack labels such as the Daily Intake Guide. The study results provide policy makers with clear guidance on the types of front-of-pack labels that are most likely to achieve positive health outcomes at a population level.

Sodium glucose cotransporter 2 (SGLT2) inhibitors are a class of medication with broad cardiovascular benefits in those with type 2 diabetes, chronic kidney disease, and heart failure. These include reductions in major adverse cardiac events and cardiovascular death. The mechanisms that underlie their benefits in atherosclerotic cardiovascular disease (ASCVD) are not well understood, but they extend beyond glucose lowering. This narrative review summarises the ASCVD benefits of SGLT2 inhibitors seen in large human outcome trials, as well as the mechanisms of action explored in rodent and small human studies. Potential pathways include favourable alterations in lipid metabolism, inflammation, and endothelial function. These all require further investigation in large human clinical trials with mechanistic endpoints, to further elucidate the disease modifying benefits of this drug class and those who will benefit most from it.

Widespread use of reduced-sodium salts can potentially lower excessive population-level dietary sodium intake. This study aimed to identify key barriers and facilitators to implementing reduced-sodium salt as a population level intervention. Semi-structured interviews were conducted with key informants from academia, the salt manufacturing industry, and government. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to inform our interview guides and data analysis. Eighteen key informants from nine countries across five World Health Organization regions participated in the study from January 2020 to July 2020. Participants were concerned about the lack of robust evidence on safety for specific populations such as those with renal impairment. Taste and price compared to regular salt and an understanding of the potential health benefits of reduced-sodium salt were identified as critical factors influencing the adoption of reduced-sodium salts. Higher production costs, low profit return, and reduced market demand for reduced-sodium salts were key barriers for industry in implementation. Participants provided recommendations as potential strategies to enhance the uptake. There are presently substantial barriers to the widespread use of reduced-sodium salt but there are also clear opportunities to take actions that would increase uptake.

An amendment to this paper has been published and can be accessed via the original article.

Increasing consumption of pre-packaged foods is likely an important driver of diet-related diseases in China. From January 2013 it became mandatory to provide a standardised nutrient declaration on pre-packaged foods in China. We collected data on pre-packaged foods from large chain supermarkets in Beijing in 2013, examined the completeness of the nutrient declaration of core required nutrients and summarised the average nutritional composition of 14 different major food groups. We also illustrated the potential use of the data by comparing sodium levels. Photos of 14,279 pre-packaged foods were collected from 16 chain supermarkets in Beijing. Data for 11,489 products were included in the evaluation of nutrient declarations and data for 10,048 in the summary analysis of average nutritional composition. Compliant nutrient declarations were displayed by 87% of products with 88% of foods displaying data for each of energy, protein, total fat, carbohydrate and sodium. Nutrients not required by the Chinese regulation were infrequently reported: saturated fat (12%), trans fat (17%) and sugars (11%). Mean sodium levels were higher in Chinese products compared to UK products for 8 of 11 major food categories, often markedly so (e.g. 1417 mg/100 g vs. 304 mg/100 g for convenience foods). There has been substantial uptake of the recently introduced Chinese nutrition labelling regulation which should help consumers to choose healthier foods. As the comparison against corresponding data about sodium from the United Kingdom shows, the nutrient data can also be used to identify broader opportunities for improvement of the food supply. Keywords: Nutrition labelling, Nutrient declaration, Nutritional composition, Pre-packaged foods, China

Unhealthy diets are underpinned by the over-consumption of packaged products. Data describing the ingredient composition of these products is limited. We sought to define the ingredients used in Australian packaged foods and beverages and assess associations between the number of ingredients and existing health indicators. Statements of ingredients were disaggregated, creating separate fields for each ingredient and sub-ingredient. Ingredients were categorised and the average number of ingredients per product was calculated. Associations between number of ingredients and both the nutrient-based Health Star Rating (HSR) and the NOVA level-of-processing classification were assessed. A total of 24,229 products, listing 233,113 ingredients, were included. Products had between 1 and 62 ingredients (median (Interquartile range (IQR)): 8 (3–14)). We identified 915 unique ingredients, which we organised into 17 major and 138 minor categories. ‘Additives’ were contained in the largest proportion of products (64.6%, (15,652/24,229)). The median number of ingredients per product was significantly lower in products with the optimum 5-star HSR (when compared to all other HSR score groups, p-value < 0.001) and significantly higher in products classified as ultra-processed (when compared to all other NOVA classification groups, p-value < 0.001). There is a strong relationship between the number of ingredients in a product and indicators of nutritional quality and level of processing.

Abstract Background Whether educational level influences the effects of health education is not clearly defined. This study examined whether the impact of a community-based dietary salt reduction program was affected by the level of education of participants. Methods The China Rural Health Initiative Sodium Reduction Study (CRHI-SRS) was a cluster-randomized controlled trial conducted in 120 villages from five Northern Chinese provinces. The intervention comprised a village-wide health education program and availability of salt substitute at village shops. 24-h urine samples were collected among 1903 participants for primary evaluation of the intervention effect. A post-hoc analysis was done to explore for heterogeneity of intervention effects by education level using generalized estimating equations. All models were adjusted for age, sex, body mass index and province. Results Daily salt intake was lower in intervention than in control at all educational levels with no evidence of a difference in the effect of the intervention across different levels of education. P value for the interaction term between education level and the intervention was 0.35. There was likewise no evidence of an interaction for effects of the intervention on potassium intake (p = 0.71), the sodium to potassium ratio (p = 0.07), or knowledge and behaviors related to salt (all p > 0.05). Conclusions The study suggests that the effects of the intervention were achieved regardless of the level of education and that the intervention should therefore be broadly effective in rural Chinese populations. Trial registration The trial was registered with clinicaltrial.gov ( NCT01259700 ).

Abstract Background Poor diets are a leading cause of disease burden worldwide. In Australia, the Federal Government established the Food and Health Dialogue (the Dialogue) in 2009 to address this issue, primarily through food reformulation. We evaluated the Dialogue’s performance over its 6 years of operation and used these findings to develop recommendations for the success of the new Healthy Food Partnership. Methods We used information from the Dialogue website, media releases, communiqués, e-newsletters, materials released under freedom-of-information, and Parliamentary Hansard to evaluate the Dialogue’s achievements from October 2013 to November 2015, using the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework. We also engaged closely with two former Dialogue members. Our findings update a prior assessment done in October 2013. Results Little data is available to evaluate the Dialogue’s recent achievements, with no information about progress against milestones released since October 2013. In the last 2 years, only one additional set of sodium reduction targets (cheese) was agreed and Quick Service Restaurant foods were added as an area for action. Some activity was identified in 12 of a possible 137 (9 %) areas of action within the Dialogue’s mandate. Independent evaluation found targets were partially achieved in some food categories, with substantial variation in success between companies. No effects on the knowledge, behaviours or nutrient intake of the Australian population or evidence of impact on diet-related disease could be identified. Conclusions The new Healthy Food Partnership has similar goals to the Dialogue. While highly laudable and recognised globally as cost-effective, the mechanism for delivery in Australia has been woefully inadequate. Strong government leadership, adequate funding, clear targets and timelines, management of conflict of interest, comprehensive monitoring and evaluation, and a plan for responsive regulation in the event of missed milestones will be required if the new Healthy Food Partnership is to achieve its urgent public health goals.

Abstract Background Salt reduction is a public health priority but there are few studies testing the efficacy of plausible salt reduction programs. Methods A multi-faceted, community-based salt reduction program using the Communication for Behavioral Impact framework was implemented in Lithgow, Australia. Single 24-h urine samples were obtained from 419 individuals at baseline (2011) and from 572 at follow-up (2014). Information about knowledge and behaviors relating to salt was also collected. Results Survey participants were on average 56 years old and 58 % female. Mean salt intake estimated from 24-h urine samples fell from 8.8 g/day (SD = 3.6 g/day) in 2011 to 8.0 (3.6) g/day in 2014 (−0.80, 95 % confidence interval −1.2 to −0.3;p

The limited Australian measures to reduce population sodium intake through national initiatives targeting sodium in the food supply have not been evaluated. The aim was, thus, to assess if there has been a change in salt intake and discretionary salt use between 2011 and 2014 in the state of Victoria, Australia. Adults drawn from a population sample provided 24 h urine collections and reported discretionary salt use in 2011 and 2014. The final sample included 307 subjects who participated in both surveys, 291 who participated in 2011 only, and 135 subjects who participated in 2014 only. Analysis included adjustment for age, gender, metropolitan area, weekend collection and participation in both surveys, where appropriate. In 2011, 598 participants: 53% female, age 57.1(12.0)(SD) years and in 2014, 442 participants: 53% female, age 61.2(10.7) years provided valid urine collections, with no difference in the mean urinary salt excretion between 2011: 7.9 (7.6, 8.2) (95% CI) g/salt/day and 2014: 7.8 (7.5, 8.1) g/salt/day (p = 0.589), and no difference in discretionary salt use: 35% (2011) and 36% (2014) reported adding salt sometimes or often/always at the table (p = 0.76). Those that sometimes or often/always added salt at the table and when cooking had 0.7 (0.7, 0.8) g/salt/day (p = 0.0016) higher salt excretion. There is no indication over this 3-year period that national salt reduction initiatives targeting the food supply have resulted in a population reduction in salt intake. More concerted efforts are required to reduce the salt content of manufactured foods, together with a consumer education campaign targeting the use of discretionary salt.

In June 2014, Australia and New Zealand adopted a voluntary front-of-pack nutrition label, the Health Star Rating (HSR) system. Our aim was to assess its uptake in Australia in the five years following adoption and examine the feasibility of proposed targets for future uptake. Numbers and proportions of products eligible to carry a HSR were recorded each year between 2014 and 2019 as part of an annual survey of four large Australian retail outlets. Uptake was projected to 2024. Mean HSR values were determined for products that were, and were not labelled with a HSR logo, and summary data presented overall, by HSR score, by major food category, by manufacturer and manufacturer group. Differences in mean HSR were assessed by independent samples t-test. HSR uptake continues to increase, appearing on 7118/17,477 (40.7%) of eligible products in 2019. Voluntary display of the HSR logo was increasing linearly at 6.8% annually. This would need to be maintained to reach 70% by 2024. Of those products displaying a HSR logo, more than three quarters (76.4%) had a HSR ≥ 3.0. Products displaying a HSR logo had a significantly higher mean HSR (3.4), compared to products not displaying a HSR logo (2.6) (p < 0.001). One hundred and thirty-nine manufacturers were using HSR, but retailers Coles, Woolworths and ALDI were together responsible for the majority of uptake (55.9%). Manufacturer members of the Australian Food and Grocery Council were responsible for 28.6% of uptake. Our findings illustrate the limits of commercial goodwill in applying HSR voluntarily. Ongoing implementation must pair clear targets and timelines for uptake with a firm pathway to make HSR mandatory if sufficient progress is not achieved.