ABSTRACT
OBJECTIVES: This post hoc analysis of SODIUM-HF (Study of Dietary Intervention under 100 mmol in Heart Failure) assessed the association between baseline dietary sodium intake and change at 6 months with a composite of cardiovascular (CV) hospitalizations, emergency department visits and all-cause death at 12 and 24 months. BACKGROUND: Dietary sodium restriction is common advice for patients with heart failure (HF). Randomized clinical trials have not shown a beneficial effect of dietary sodium restriction on clinical outcomes. METHODS: A multivariable Cox proportional hazard regression model was used to assess the association of dietary sodium intake measured at randomization with primary and secondary endpoints. RESULTS: The study included 792 participants. Baseline sodium intake was ≤ 1500 mg/day in 19.9% (nâ¯=â¯158), 1501-3000 mg/day in 56.5% (nâ¯=â¯448) and > 3000 mg/day in 23.4% (nâ¯=â¯186) of participants. The factors associated with higher baseline sodium intake were higher calorie consumption, higher body mass index and recruitment from Canada. Multivariable analyses showed no association between baseline sodium intake nor magnitude of 6-month change or 12- or 24-month outcomes. In a responder analysis, participants achieving a sodium intake < 1500 mg at 6 months showed an association with a decreased risk for the composite outcome (adjusted HR 0.52 [95% CI 0.25, 1.07] Pâ¯=â¯0.08) and CV hospitalization (adjusted HR 0.51 [95% CI 0.24, 1.09] Pâ¯=â¯0.08) at 12 months. CONCLUSION: There was no association between dietary sodium intake and clinical outcomes over 24 months in patients with HF. Responder analyses suggest the need for further investigation of the effects of sodium reduction in those who achieve the targeted dietary sodium-reduction level.
ABSTRACT
BACKGROUND: Dietary restriction of sodium has been suggested to prevent fluid overload and adverse outcomes for patients with heart failure. We designed the Study of Dietary Intervention under 100 mmol in Heart Failure (SODIUM-HF) to test whether or not a reduction in dietary sodium reduces the incidence of future clinical events. METHODS: SODIUM-HF is an international, open-label, randomised, controlled trial that enrolled patients at 26 sites in six countries (Australia, Canada, Chile, Colombia, Mexico, and New Zealand). Eligible patients were aged 18 years or older, with chronic heart failure (New York Heart Association [NYHA] functional class 2-3), and receiving optimally tolerated guideline-directed medical treatment. Patients were randomly assigned (1:1), using a standard number generator and varying block sizes of two, four, or six, stratified by site, to either usual care according to local guidelines or a low sodium diet of less than 100 mmol (ie, <1500 mg/day). The primary outcome was the composite of cardiovascular-related admission to hospital, cardiovascular-related emergency department visit, or all-cause death within 12 months in the intention-to-treat (ITT) population (ie, all randomly assigned patients). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT02012179, and is closed to accrual. FINDINGS: Between March 24, 2014, and Dec 9, 2020, 806 patients were randomly assigned to a low sodium diet (n=397) or usual care (n=409). Median age was 67 years (IQR 58-74) and 268 (33%) were women and 538 (66%) were men. Between baseline and 12 months, the median sodium intake decreased from 2286 mg/day (IQR 1653-3005) to 1658 mg/day (1301-2189) in the low sodium group and from 2119 mg/day (1673-2804) to 2073 mg/day (1541-2900) in the usual care group. By 12 months, events comprising the primary outcome had occurred in 60 (15%) of 397 patients in the low sodium diet group and 70 (17%) of 409 in the usual care group (hazard ratio [HR] 0·89 [95% CI 0·63-1·26]; p=0·53). All-cause death occurred in 22 (6%) patients in the low sodium diet group and 17 (4%) in the usual care group (HR 1·38 [0·73-2·60]; p=0·32), cardiovascular-related hospitalisation occurred in 40 (10%) patients in the low sodium diet group and 51 (12%) patients in the usual care group (HR 0·82 [0·54-1·24]; p=0·36), and cardiovascular-related emergency department visits occurred in 17 (4%) patients in the low sodium diet group and 15 (4%) patients in the usual care group (HR 1·21 [0·60-2·41]; p=0·60). No safety events related to the study treatment were reported in either group. INTERPRETATION: In ambulatory patients with heart failure, a dietary intervention to reduce sodium intake did not reduce clinical events. FUNDING: Canadian Institutes of Health Research and the University Hospital Foundation, Edmonton, Alberta, Canada, and Health Research Council of New Zealand.
Subject(s)
Heart Failure , Sodium, Dietary , Aged , Canada , Female , Heart Failure/drug therapy , Humans , Male , Sodium , Treatment OutcomeABSTRACT
OBJECTIVE: This study aimed to compare the effect of the use of a renal-specific oral nutritional supplement (RS-ONS) during hemodialysis sessions and the use of RS-ONS at home on the incidence of intradialytic hypotension. METHODS: A single-center, 12-week, open-label, randomized controlled clinical trial was conducted. The intervention was a RN-ONS divided into two portions: 100 and 137 mL. The first portion was given after 1 hour of hemodialysis (HD) treatment, while the second portion was given 45 minutes before the end of HD. The research staff registered the baseline and final nutritional parameters and systolic arterial pressure (SAP) from the screen of the HD device during 36 HD sessions. Hypotension symptoms were also recorded every hour during each HD session. The nutritional and functional status was also assessed. RESULTS: We registered a total of 16 hypotensive events during 1082 HD sessions: 9 were in patients supplemented at home (551 HD sessions) and 7 occurred in patients supplemented during HD P = .668. Incidence of intradialytic hypotension (IH) during 1082 HD sessions was 1.4%. The total malnutrition inflammation score (MIS) decreased in both groups (P < .01), and the percentage of cachexia improved in the supplemented-during-HD group (P < .05). CONCLUSIONS: In this randomized controlled trial, intradialytic hypotension events did not increase with the RS-ONS during HD treatment. This strategy appears to be a safe anabolic nutritional strategy for the prevention of PEW, selecting stable patients and administering a fractioned volume of the supplement after the first hour of HD treatment. More studies with larger samples size are required to confirm these findings.
Subject(s)
Hypotension , Kidney Failure, Chronic , Blood Pressure , Dietary Supplements , Humans , Hypotension/epidemiology , Hypotension/etiology , Hypotension/prevention & control , Kidney Failure, Chronic/therapy , Renal DialysisABSTRACT
Excess sodium intake is associated with adverse health effects, and reducing its intake is a strategy that improves population health. However, estimating sodium intake is challenging and new options for assessment are needed. This review describes the design and development of a web-based, publicly-accessible, dietary sodium intake screening tool (Calculadora de Sodio) for individuals in Mexico. Sodium data from 2017 - 2018 for 3 429 packaged foods, 655 restaurant and cafeteria foods, and 320 home-style meals and street foods (determined by chemical analysis) comprised the 71-question tool. It was piloted with 10 nutrition experts for feedback on content and face validity; and with 30 potential users to test its usability and interface. Improvements were made to content, language, and formatting following the pilot. Its predictive validity will be established in the future. The Calculadora de Sodio provides instant feedback on an individual's average daily sodium intake, computed by frequency of intake, average number of servings, and sodium content per serving of each sodium-focused food category. This is the first web-based dietary sodium screening tool developed for the general population of Mexico. It is an efficient and practical way to assess sodium intake and can serve as a model for similar tools for other countries and regions.
La ingesta excesiva de sodio se asocia a efectos nocivos para la salud y su reducción constituye una estrategia para mejorar la salud de la población. Sin embargo, es complicado estimar la ingesta de sodio y se necesitan nuevas alternativas para evaluarla. En este examen se describe el diseño y la creación de una herramienta en línea y de acceso público con el fin de establecer la ingesta de sodio en la alimentación (denominada la "calculadora de sodio") para la población de México. La herramienta, consistente en 71 preguntas, incluye los datos de sodio correspondientes al 2017-2018 de 3 429 alimentos envasados, 655 alimentos de restaurantes y cafeterías y 320 comidas caseras y alimentos de puestos de venta de la calle (determinados mediante análisis químicos). Se hizo una prueba piloto con diez nutricionistas que aportaron su opinión experta en materia de validez del contenido y diseño, además de 30 usuarios potenciales que probaron la facilidad de uso y su interfaz. Tras la prueba piloto, se incluyeron mejoras de contenido, idioma y formato. En el futuro se podrá determinar su valor predictivo. La calculadora de sodio ofrece una evaluación instantánea sobre la ingesta de sodio promedio diaria de una persona, calculada según la frecuencia de la ingesta, la cantidad promedio de raciones y el contenido de sodio por ración de cada categoría de alimentos con sodio. Esta es la primera herramienta en línea de detección de sodio en los alimentos creada para la población general de México. Es una manera eficaz y práctica de evaluar la ingesta de sodio, y puede servir de modelo para herramientas similares en otros países y regiones.
A ingestão de sódio em excesso está associada a efeitos adversos à saúde, e a redução do consumo alimentar de sódio é uma estratégia que contribui para a melhoria da saúde das pessoas. Porém, como é difícil estimar a ingestão de sódio, são necessários novos métodos de avaliação. Neste estudo são apresentados o projeto e o desenvolvimento de um instrumento on-line e aberto ao público (denominado ''calculadora de sódio'') para a triagem da ingestão alimentar de sódio por indivíduos no México. O instrumento contém 71 perguntas preparadas com base em dados do teor de sódio, coletados no período de 2017 a 2018, de 3.429 alimentos embalados, 655 alimentos comercializados em restaurantes e lanchonetes e 320 refeições do tipo caseiro e comidas de rua (medidos com análises químicas). Um teste-piloto foi realizado com 10 especialistas em nutrição, que fizeram observações sobre a validade de conteúdo e a validade aparente do instrumento, e 30 possíveis usuários que avaliaram sua usabilidade e interface. O conteúdo, os enunciados e o formato foram aperfeiçoados após o teste-piloto. A validade preditiva do instrumento será determinada futuramente. A ''calculadora de sódio'' proporciona uma avaliação imediata da ingestão alimentar média de sódio de uma pessoa, calculada pela frequência de consumo, número médio de porções e teor de sódio por porção de cada categoria de alimento que contém sódio. Este é o primeiro instrumento on-line para a triagem de sódio alimentar desenvolvido para a população do México. É um recurso eficiente e prático para avaliar a ingestão de sódio e pode servir de modelo para o desenvolvimento de instrumentos semelhantes em outros países e regiões.
ABSTRACT
BACKGROUND: Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF. METHODS: The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients. CONCLUSIONS: The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
Subject(s)
Diet, Sodium-Restricted/methods , Heart Failure/diet therapy , Hospitalization/statistics & numerical data , Quality of Life , Stroke Volume/physiology , Aged , Female , Heart Failure/physiopathology , Humans , Male , Middle Aged , Treatment Outcome , Walk TestABSTRACT
PURPOSE OF REVIEW: Recognizing the relevance of sodium balance in heart failure, it has been presumed that patients with heart failure benefit from a low-sodium diet, though its efficacy and safety are unclear. The purpose of this review is to provide insight into the currently available evidence base for the effects of dietary sodium restriction in patients with chronic heart failure. RECENT FINDINGS: There has been an increasing body of evidence on the effects of sodium restriction in heart failure; however, both observational and experimental studies have shown mixed results. Recent randomized controlled trial data has even suggested that sodium restriction may have detrimental effects in patients with heart failure. Only a few randomized controlled trials have included clinical outcomes as a primary endpoint. These have been either unpowered to test the association between reduced sodium intake and outcomes, or conducted in the context of an aggressive diuretic treatment and fluid restriction. SUMMARY: The effects of a low-sodium diet on clinical outcomes in patients with heart failure remain unclear. Ongoing research into the effects of lowering sodium for patients with chronic or acute heart failure will shed light on the importance of holistic self-care and dietary strategies in heart failure.
Subject(s)
Diet, Sodium-Restricted , Heart Failure , Sodium/metabolism , Water-Electrolyte Balance , Chronic Disease , Diet, Sodium-Restricted/adverse effects , Diet, Sodium-Restricted/methods , Heart Failure/diet therapy , Heart Failure/metabolism , Humans , Outcome Assessment, Health Care , Treatment OutcomeABSTRACT
AIMS: To determine the feasibility of conducting a randomized controlled trial comparing a low-sodium to a moderate-sodium diet in heart failure (HF) patients. METHODS AND RESULTS: Patients with HF (New York Heart Association classes II-III) were randomized to low (1500 mg/d) or moderate-sodium (2300 mg/d) diet. Dietary intake was evaluated using 3-day food records. The end points were changes in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and B-type natriuretic peptide (BNP) levels from baseline to 6 months of follow-up presented as medians [25th, 75th percentiles]. Thirty-eight patients were enrolled (19/group). After 6 months, median sodium intake declined from 2137 to 1398 mg/d in the low-sodium and from 2678 to 1461 mg/d in the moderate-sodium diet group. Median BNP levels in the low-sodium diet group declined (216-71 pg/mL, P = .006), whereas in the moderate-sodium diet group, there was no change in BNP (171-188 pg/mL, P = .7; P = .17 between groups). For 6 months, median KCCQ clinical score increased in both groups (63-75 [P = .006] in the low-sodium diet group and 66-73 [P = .07] in the moderate-sodium group; P = .4 between groups). At 6 months, a post hoc analysis based on the dietary sodium intake achieved (> or ≤ 1,500 mg/d) in all patients showed an association between a sodium intake ≤ 1,500 mg/d and improvement in BNP levels and KCCQ scores. CONCLUSIONS: A dietary intervention restricting sodium intake was feasible, and achievement of this sodium goal was associated with lower BNP levels and improved quality of life in patients with HF.
Subject(s)
Diet, Sodium-Restricted/methods , Heart Failure/diet therapy , Natriuretic Peptide, Brain/blood , Quality of Life , Sodium, Dietary/pharmacology , Aged , Feasibility Studies , Female , Heart Failure/blood , Heart Failure/physiopathology , Heart Failure/psychology , Humans , Male , Middle Aged , Pilot Projects , Severity of Illness Index , Statistics as Topic , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Estimating dietary sodium intake is a key component of dietary assessment in the clinical setting of HF to effectively implement appropriate dietary interventions for sodium reduction and monitor adherence to the dietary treatment. In a research setting, assessment of sodium intake is crucial to an essential methodology to evaluate outcomes after a dietary or behavioral intervention. Current available sodium intake assessment methods include 24-hour urine collection, spot urine collections, multiple day food records, food recalls, and food frequency questionnaires. However, these methods have inherent limitations that make assessment of sodium intake challenging, and the utility of traditional methods may be questionable for estimating sodium intake in patients with HF. Thus, there are remaining questions about how to best assess dietary sodium intake in this patient population, and there is a need to identify a reliable method to assess and monitor sodium intake in the research and clinical setting of HF. This paper provides a comprehensive review of the current methods for sodium intake assessment, addresses the challenges for its accurate evaluation, and highlights the relevance of applying the highest-quality measurement methods in the research setting to minimize the risk of biased data.
Subject(s)
Diet, Sodium-Restricted , Heart Failure/physiopathology , Nutrition Assessment , Sodium Chloride, Dietary/adverse effects , Sodium Chloride, Dietary/metabolism , Age Factors , Female , Heart Failure/prevention & control , Humans , Male , Needs Assessment , Practice Guidelines as Topic , Prognosis , Recommended Dietary Allowances , Risk Assessment , Sex FactorsABSTRACT
BACKGROUND: Sodium restriction is the primary dietary therapy in heart failure (HF); however, assessing sodium intake is challenging to clinicians, who commonly rely on patients' self-report of following a low-sodium diet to determine adherence. It is important to further explore the utility of self-reported adherence to a low-sodium diet in patients with HF. OBJECTIVES: The objective of this study was to evaluate the association between patients' self-reported adherence to a low-sodium diet and dietary habits related to sodium intake in patients with chronic HF. METHODS: Patients with HF seen in a tertiary care Heart Function Clinic and who have been taught on a low-sodium diet with a target of less than 2300 mg/d were included. Self-perception of compliance and dietary habits related to sodium intake was evaluated by using a dietary questionnaire. Patients were divided into 3 groups according to self-reported adherence to a low-sodium diet: never, sometimes, and always. RESULTS: Overall, 237 patients (median age, 66 years, 72.6% men) were included. Compared with the other 2 groups, patients who stated always following a low-sodium diet were less likely to use salt in cooking or at the table. However, 4.2% of the patients in the always group reported eating canned or package soups every day. Moreover, the highest proportion of patients eating fast foods 1 to 3 times a week was found among those in the sometimes group (22.9%) compared with the never (9.1%) and always (6.7%) groups (P = .002). Importantly, the rest of the food items did not show any significant differences between self-reported adherence groups. CONCLUSION: Self-report of adherence to a low-sodium diet is not reliable among patients with HF, who associate the idea of following a low-sodium diet mainly with not using salt for cooking or at the table but not with reducing frequency of intake of high-sodium processed foods.
Subject(s)
Diet, Sodium-Restricted , Feeding Behavior , Heart Failure/diet therapy , Patient Compliance , Self Report , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Surveys and QuestionnairesABSTRACT
OBJECTIVES: To evaluate children's risk of being overweight associated with maternal underestimation of weight status and health behaviors. RESULTS: One hundred forty mother-child dyads were included. Children whose weight status was underestimated by their mothers were at greater risks of being overweight compared to those whose weigh status was correctly perceived (adjusted OR 2.31, 95% CI 1.11-4.81). Less television viewing time was associated with a 63% reduced risk of being overweight (adjusted OR .37, 95% CI .17-.83). CONCLUSIONS: Maternal underestimation of weight status was common among overweight and normal-weight children, and it was associated with an increased children's risk of being overweight.
Subject(s)
Body Mass Index , Health Knowledge, Attitudes, Practice , Pediatric Obesity/psychology , Weight Perception , Adult , Body Weight/physiology , Chi-Square Distribution , Child , Child, Preschool , Cross-Sectional Studies , Female , Health Behavior , Humans , Logistic Models , Male , Mother-Child Relations/psychology , Mothers/psychology , Overweight/epidemiology , Overweight/psychology , Pediatric Obesity/epidemiology , Reference Values , Risk FactorsABSTRACT
The field of heart failure has evolved in terms of the therapies that are available including pharmaceutical and device therapies. There is now substantial randomized trial data to indicate that dietary sodium restriction does not provide the reduction in clinical events with accepted heterogeneity in the clinical trial results. Dietary sodium restriction should be considered for some but not all patients and with different objectives than clinical outcomes but instead for potential quality of life benefit. In addition, fluid restriction, once the mainstay of clinical practice, has not shown to be of any additional benefit for patients in hospital or in the ambulatory care setting and therefore should be considered to be used cautiously (if at all) in clinical practice. Further developments and clinical trials are needed in this area to better identify patients who may benefit or have harm from these lower cost interventions and future research should focus on large scale, high quality, clinical trials rather than observational data to drive clinical practice.
Subject(s)
Heart Failure , Sodium, Dietary , Humans , Sodium , Quality of Life , Heart Failure/diagnosis , Heart Failure/therapy , Pharmaceutical PreparationsABSTRACT
Childhood obesity is linked to diverse health outcomes, including elevated blood pressure (EBP). Emerging evidence showed that excess fat mass (FM) may have a deleterious impact on blood pressure even in normal-weight children. The primary objective of this study was to assess the association between body weight status by BMI z-score and body composition parameters by conventional bioelectrical impedance analysis (BIA) and bioelectrical impedance vector analysis (BIVA). Also, we aimed to explore the performance of BMI z-score, %FM, and FM index (FMI) in discriminating EBP in a sample of school-age Mexican children. Children were classified as having normal weight, overweight or obesity according to WHO criteria for BMI z-score. FMI was considered high when above 75th percentile, and fat free mass index (FFMI) was considered low when below 25th percentile of the reference population. Body composition was also classified according to the BIVA method and EBP was determined when systolic and/or diastolic blood pressure ≥ 90th percentile. BMI z-score groups were compared by Student´s t-test or the Mann-Whitney U test, or by the chi-square test or Fisher exact test. Receiving operating characteristic (ROC) analysis was performed. 61 children were included (52.5% boys, median age 9.8 (25th, 75th percentiles: 8.5, 11.0)) years. High FMI was observed in 32.3% of children with normal weight. Low FFMI was present in 93.5% of children with normal weight and 53.3% of those with overweight/obesity. According to BIVA, 58.1% and 43.3% of children with normal weight and overweight/obesity were classified as having cachexia. All the three adiposity indicators showed significant areas under the ROC curve (AURC) greater than 0.775 for EBP, with the largest one displayed for FM% (0.794). Hight FMI and low FFMI are common in children with normal weight. Identifying deficiency of FFM might be limited by using solely BMI indicators. Cachexia by BIVA was present in a high proportion of children with either normal weight or overweight/obesity. Both BMI z-score and FM (% and FMI) performed well at discriminating EBP, with a numerically greater AURC observed for FM%. Body composition in pediatric population is relevant for identifying body composition abnormalities at early age.
Subject(s)
Hypertension , Pediatric Obesity , Child , Male , Humans , Female , Blood Pressure , Cross-Sectional Studies , Overweight , Body Mass Index , Cachexia , Pediatric Obesity/diagnosis , Pediatric Obesity/epidemiology , Body Composition , Hand StrengthABSTRACT
Dietary fibers are associated with favorable gastrointestinal, immune, and metabolic health outcomes when consumed at sufficient levels. Despite the well-described benefits of dietary fibers, children and adolescents continue to fall short of daily recommended levels. This gap in fiber intake (i.e., "fiber gap") might increase the risk of developing early-onset pediatric obesity and obesity-related comorbidities such as type 2 diabetes mellitus into adulthood. The structure-dependent physicochemical properties of dietary fiber are diverse. Differences in solubility, viscosity, water-holding capacity, binding capability, bulking effect, and fermentability influence the physiological effects of dietary fibers that aid in regulating appetite, glycemic and lipidemic responses, and inflammation. Of growing interest is the fermentation of fibers by the gut microbiota, which yields both beneficial and less favorable end-products such as short-chain fatty acids (e.g., acetate, propionate, and butyrate) that impart metabolic and immunomodulatory properties, and gases (e.g., hydrogen, carbon dioxide, and methane) that cause gastrointestinal symptoms, respectively. This narrative review summarizes (1) the implications of fibers on the gut microbiota and the pathophysiology of pediatric obesity, (2) some factors that potentially contribute to the fiber gap with an emphasis on undesirable gastrointestinal symptoms, (3) some methods to alleviate fiber-induced symptoms, and (4) the therapeutic potential of whole foods and commonly marketed fiber supplements for improved health in pediatric obesity.
Subject(s)
Dietary Fiber , Gastrointestinal Microbiome , Pediatric Obesity , Humans , Dietary Fiber/pharmacology , Child , Gastrointestinal Microbiome/physiology , AdolescentABSTRACT
BACKGROUND: In heart failure (HF) trials, there has been an emphasis on utilizing more patient-centered outcomes, including quality of life (QoL) and days alive and out of hospital. We aimed to explore the impact of QoL adjusted days alive and out of hospital as an outcome in 2 HF clinical trials. METHODS: Using data from 2 trials in HF (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT] and Study of Dietary Intervention under 100 mmol in Heart Failure [SODIUM-HF]), we determined treatment differences using percentage days alive and out of hospital (%DAOH) adjusted for QoL at 18 months as the primary outcome. For each participant, %DAOH was calculated as a ratio between days alive and out of hospital/total follow-up. Using a regression model, %DAOH was subsequently adjusted for QoL measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. RESULTS: In the GUIDE-IT trial, 847 participants had a median baseline Kansas City Cardiomyopathy Questionnaire Overall Summary Score of 59.0 (interquartile range, 40.8-74.3), which did not change over 18 months. %DAOH was 90.76%±22.09% in the biomarker-guided arm and 88.56%±25.27% in the usual care arm. No significant difference in QoL adjusted %DAOH was observed (1.09% [95% CI, -1.57% to 3.97%]). In the SODIUM-HF trial, 796 participants had a median baseline Kansas City Cardiomyopathy Questionnaire Overall Summary Score of 69.8 (interquartile range, 49.3-84.3), which did not change over 18 months. %DAOH was 95.69%±16.31% in the low-sodium arm and 95.95%±14.76% in the usual care arm. No significant difference was observed (1.91% [95% CI, -0.85% to 4.77%]). CONCLUSIONS: In 2 large HF clinical trials, adjusting %DAOH for QoL was feasible and may provide complementary information on treatment effects in clinical trials.
Subject(s)
Heart Failure , Quality of Life , Humans , Heart Failure/therapy , Heart Failure/diagnosis , Heart Failure/mortality , Female , Male , Time Factors , Aged , Middle Aged , Treatment Outcome , Randomized Controlled Trials as Topic , Recovery of Function , Diet, Sodium-Restricted , Surveys and QuestionnairesABSTRACT
Atherogenesis and dyslipidemia increase the risk of cardiovascular disease, which is the leading cause of death in developed countries. While blood lipid levels have been studied as disease predictors, their accuracy in predicting cardiovascular risk is limited due to their high interindividual and interpopulation variability. The lipid ratios, atherogenic index of plasma (AIP = log TG/HDL-C) and the Castelli risk index 2 (CI2 = LDL-C/HDL-C), have been proposed as better predictors of cardiovascular risk, but the genetic variability associated with these ratios has not been investigated. This study aimed to identify genetic associations with these indexes. The study population (n = 426) included males (40%) and females (60%) aged 18-52 years (mean 39 years); the Infinium GSA array was used for genotyping. Regression models were developed using R and PLINK. AIP was associated with variation on APOC3, KCND3, CYBA, CCDC141/TTN, and ARRB1 (p-value < 2.1 × 10-6). The three former were previously associated with blood lipids, while CI2 was associated with variants on DIPK2B, LIPC, and 10q21.3 rs11251177 (p-value 1.1 × 10-7). The latter was previously linked to coronary atherosclerosis and hypertension. KCND3 rs6703437 was associated with both indexes. This study is the first to characterize the potential link between genetic variation and atherogenic indexes, AIP, and CI2, highlighting the relationship between genetic variation and dyslipidemia predictors. These results also contribute to consolidating the genetics of blood lipid and lipid indexes.
Subject(s)
Atherosclerosis , Coronary Artery Disease , Dyslipidemias , Male , Female , Humans , Case-Control Studies , Atherosclerosis/genetics , Coronary Artery Disease/genetics , Lipids , Dyslipidemias/geneticsABSTRACT
BACKGROUND: Sodium restriction is a nonpharmacologic treatment suggested by practice guidelines for the management of patients with heart failure (HF). In this study, we synthesized the data from randomized controlled trials (RCTs) evaluating the effects of sodium restriction on clinical outcomes in patients with HF. METHODS: In this aggregate data meta-analysis, Cochrane Central, MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase Ovid, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) Plus databases were searched up to April 2, 2022. RCTs were included if they investigated the effects of sodium/salt restriction as compared to no restriction on clinical outcomes in patients with HF. Outcomes of interest included mortality, hospitalization, change in New York Heart Association functional class, and quality of life (QoL). RESULTS: Seventeen RCTs were identified (834 and 871 patients in intervention and control groups, respectively). Sodium restriction did not reduce the risk of all-cause death (odds ratio, 0.95 [95% CI, 0.58-1.58]), hospitalization (odds ratio, 0.84 [95% CI, 0.62-1.13]), or the composite of death/hospitalization (odds ratio, 0.88 [95% CI, 0.63-1.23]). The results were similar in different subgroups, except for the numerically lower risk of death with reduced sodium intake reported in RCTs with dietary sodium at the 2000 to 3000 mg/d range as opposed to <2000 mg/d (and in RCTs with versus without fluid restriction as a co-intervention). Among RCTs reporting New York Heart Association change, 2 RCTs (which accounted for two-thirds of the data) showed improvement in New York Heart Association class with sodium restriction. Substantial heterogeneity existed for QoL: 6 RCTs showed improvement of QoL and 4 RCTs showed no improvement of sodium restriction on QoL. CONCLUSIONS: In a meta-analysis of RCTs, sodium restriction was not associated with fewer deaths or hospitalizations in patients with HF. Dietary sodium restriction may be associated with improvements in symptoms and QoL.
Subject(s)
Heart Failure , Sodium, Dietary , Humans , Heart Failure/diagnosis , Heart Failure/therapy , Sodium , Randomized Controlled Trials as Topic , HospitalizationABSTRACT
Background: Preclinical and observational studies suggest that the gut microbiome plays a role in the pathogenesis of heart failure (HF); the gut microbiome may be modified by fermentable dietary fibre (FDF). The Need for Fiber Addition in Symptomatic Heart Failure (FEAST-HF) trial evaluated feasibility of recruitment and supplementation with FDF in HF and whether FDF (acacia), compared to control, reduced the level of N-terminal pro-b-type natriuretic peptide (NT-proBNP) and growth stimulation expressed gene 2 (ST2), and produced changes in the gut microbiome. Methods: Participants were randomly allocated 1:1:1 to either of the intervention arms (5 g/d or 10 g/d acacia) or to the control arm (10 g/d microcrystalline cellulose (MCC; nonfermentable active control). Adherence and tolerance were assessed, and clinical events were monitored for safety. All outcomes (NT-proBNP, ST2, New York Heart Association class, Kansas City Cardiomyopathy Questionnaire scores, 6-minute walk test score, gut microbiome) were measured at baseline, and at 6 and 12 weeks. Results: Between September 13, 2018 and December 16, 2021, 51 patients were randomly allocated to either MCC (n = 18), acacia 5 g daily (n = 13), or acacia 10 g daily (n = 18). No differences occurred between either dose of acacia and MCC in NT-proBNP level, ST2, New York Heart Association class, or questionnaire scores over 12 weeks. Dietary treatment arms had a negligible impact on microbial communities. No safety, tolerability, or adherence issues were observed. Conclusions: Dietary supplementation with acacia gum was both safe and well tolerated in ambulatory patients with HF; however, it did not change NT-proBNP level, ST2, or the composition of the gut microbiome.ClinicalTrials.gov: NCT03409926.
Contexte: Des études précliniques et observationnelles donnent à penser que le microbiome intestinal joue un rôle dans la pathogenèse de l'insuffisance cardiaque (IC). Or, ce microbiome pourrait être modifié par la consommation de fibres alimentaires fermentescibles (FAF). L'essai pilote contrôlé avec répartition aléatoire FEAST-HF (pour The Need forFiberAddition inSymptomaticHeartFailure) visait à évaluer la possibilité d'administrer un supplément de FAF (l'acacia) et à déterminer si celui-ci entraîne une réduction du taux du propeptide natriurétique de type B N-terminal (NT-proBNP) et du récepteur ST2 (growth stimulation expressed gene 2) ou une modification du microbiome intestinal comparativement au placebo. Méthodologie: Les participants ont été répartis de façon aléatoire selon un rapport 1:1:1 dans l'un des groupes d'intervention (recevant 5 g/jour ou 10 g/jour d'acacia) ou dans le groupe témoin (recevant 10 g/jour de cellulose microcristalline [CMC], une fibre de référence non fermentescible). La tolérance et l'observance du traitement ont été évaluées, et les événements cliniques ont été surveillés pour évaluer l'innocuité. Tous les indicateurs (NT-proBNP, ST2, classe d'IC selon l'échelle de la New York Heart Association, score au questionnaire de cardiomyopathie de Kansas City, score à un test de marche de 6 minutes et microbiome intestinal) ont été évalués au début de l'étude, à la semaine 6 et à la semaine 12. Résultats: Entre le 13 septembre 2018 et le 16 décembre 2021, 51 patients ont pris, après répartition aléatoire, de la CMC (n = 18), 5 g d'acacia par jour (n = 13) ou 10 g d'acacia par jour (n = 18). Aucune différence n'a été observée quant au taux de NT-proBNP ou de ST2, à la classe d'IC selon la New York Heart Association ou aux scores au questionnaire entre les groupes prenant l'une ou l'autre des doses d'acacia et le groupe prenant la CMC au cours d'une période de 12 semaines. L'effet sur la flore microbienne était négligeable dans les groupes de traitement alimentaire. Par ailleurs, aucun problème lié à l'innocuité, à la tolérabilité ou à l'observance du traitement n'a été observé. Conclusions: Les suppléments alimentaires d'acacia (gomme arabique) sont sûrs et bien tolérés; toutefois, ces suppléments n'ont pas entraîné de changement dans les taux de NT-proBNP ou de ST2, ni dans la composition du microbiome intestinal.ClinicalTrials.gov : NCT03409926.
ABSTRACT
Children with Prader-Willi syndrome (PWS) are characterized by severe obesity. Asprosin is a newly discovered protein hormone produced by the white adipose tissue and is correlated with insulin resistance. The aim of our study was to describe the concentrations of serum asprosin in children with PWS compared to those with overweight/obesity and normal weight, and to explore the postprandial change in asprosin concentrations in participants with PWS and BMI-z matched controls. We enrolled 52 children, 23 with PWS, 8 with overweight/obesity, and 21 with normal weight. Fasting levels of asprosin, glucose, and insulin were collected in all children, and postprandial asprosin and fasting levels of acyl ghrelin (AG) and leptin were also determined in a subsample of participants. There were no significant differences among groups in fasting levels of asprosin, glucose, insulin, and HOMA-IR. Fasting serum asprosin and 1-h post-meal serum asprosin did not differ in children with PWS nor in BMI-z matched controls. Fasting asprosin showed an adjusted positive correlation with glucose in children with obesity (r = 0.93, p = 0.007) but not in children with PWS nor children with normal weight. Circulating asprosin might be a predictor of early alterations in glucose metabolism in children with obesity. More research is needed to further explain the association between asprosin, food intake, metabolism, and obesity in PWS.
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INTRODUCTION: Background: adherence to Dietary Approach to Stop Hypertension (DASH) has demonstrated to be effective in lowering blood pressure and other cardiovascular risk markers in different populations, but has never been evaluated in the Mexican population. Objective: to assess adherence to the DASH dietary pattern by using an adapted DASH adequacy index (DASH-AI), and to evaluate its association with cardiovascular risk markers in an adult Mexican population. Methods: we conducted a cross-sectional analysis of data of 1,490 adults aged 20-50 years. Diet was assessed with a Food Frequency Questionnaire and sodium intake by 24-hour urinary sodium excretion; the DASH-AI score was calculated based on the DASH nutrient targets. Multivariable linear and logistic regression analyses were performed to estimate the association between the DASH-AI score and cardiovascular risk markers (body mass index [BMI], waist circumferences, systolic (SBP) and diastolic blood pressure (DBP), glucose, triglycerides, total cholesterol, and high- and low-density lipoproteins). Results: we observed an association of the DASH-AI score with BMI, WC and DBP in the linear (BMI, ï¢: -0.55, 95 % CI: -0.77, -0.33; WC, ï¢: -1.66, 95 % CI: -2.19, -1.13; DBP, ï¢: -0.65, 95 % CI: -1.07, -0.24), and logistic (BMI > 25 kg/m2, OR: 0.82, 95 % CI: 0.74, 0.93; elevated WC, OR: 0.72, 95 % CI: 0.64, 0.81; DBP, OR: 0.83, 95 % CI: 0.72, 0 .95) models. Conclusion: compliance to the DASH-style diet was inversely associated with BMI, WC and DBP in this Mexican population. Promoting adherence to this dietary pattern in the context of Mexican diet is needed to improve cardiovascular health in this population.
INTRODUCCIÓN: Antecedentes: la adherencia al patrón de alimentación DASH ha mostrado ser eficaz para reducir la presión arterial y los marcadores de riesgo cardiovascular en diferentes poblaciones, pero nunca en la mexicana. Objetivo: evaluar la adherencia al patrón de alimentación DASH mediante un índice adapatado a los lineamientos DASH (DASH-AI) y evaluar su asociación con marcadores de riesgo. Métodos: análisis transversal de datos de 1490 adultos de entre 20 y 50 años de edad. La ingesta dietética se evaluó utilizando un cuestionario de frecuencia de consumo de alimentos y el sodio a través de la excresión urinaria en 24 horas; la puntuación DASH-AI se calculó de acuerdo con la adherencia a las recomendaciones DASH. Se realizaron modelos logísticos y lineales para estimar la asociación entre el puntaje DASH-AI y los marcadores de riesgo cardiovascular (índice de masa corporal [IMC], circunferencia de cintura (CC), presión arterial sistólica (PAS) y diastólica (PAD), glucosa, triglicéridos, colesterol total, lipoproteínas de alta y baja densidad). Resultados: observamos una asociación del DASH-AI con el IMC, la CC y la PAD en los modelos lineales (IMC ï¢: -0,55, IC del 95 %: -0,77, -0,33; CC ï¢: -1,66, IC del 95 %: -2,19, -1,33; PAD, ï¢: -0,65, IC del 95 %: -1,07, -0,24) y logístico (IMC > 25 kg/m2, OR: 0,82, IC del 95 %: 0,74, 0,93; CC elevado, OR: 0,72; IC del 95 %: 0,64, 0,81; PAD, OR: 0,83, IC del 95 %: 0,72, 0,95). Conclusión: la adherencia a la dieta DASH se asoció inversamente con el IMC, la CC y la PAD en la población estudiada. Es necesario promover la adherencia a este patrón dietético para mejorar la salud cardiovascular.
Subject(s)
Dietary Approaches To Stop Hypertension , Hypertension , Adult , Blood Pressure , Cross-Sectional Studies , Diet , Humans , Hypertension/epidemiology , Middle Aged , Young AdultABSTRACT
INTRODUCTION: Objective: the aim of this study was to identify dietary patterns in a sample of patients with type-2 diabetes, and to evaluate their association with markers of metabolic control. Methods: a cross-sectional study in 395 patients with type-2 diabetes in primary care was conducted. Fasting blood levels of glycated hemoglobin (A1c), glucose, total cholesterol, low- (LDL-c) and high-density lipoprotein cholesterol (HDL-c), and triglycerides were measured. Waist circumference, body mass index (BMI), and blood pressure were evaluated. Dietary intake was assessed by a food frequency questionnaire, and dietary patterns were derived by cluster analysis. Three dietary patterns were identified: 'fruits and vegetables', 'dairy and sweetened beverages', and 'diverse with alcohol'. Results: an association between the 'dairy and sweetened beverages' dietary pattern and A1c levels was identified (ß = 0.61; 95 % CI: 0.09, 1.12, p = 0.021), considering the 'fruits and vegetables' dietary pattern as the reference group. We also observed a trend towards an adjusted increased risk of A1c ≥ 7 % (odds ratio [OR]: 1.56; 95 % CI: 0.92, 2.64; p = 0.099) and an increased risk of BMI ≥ 25 kg/m2 (OR: 2.62, 95 % CI: 1.20, 5.71, p = 0.015) among patients in the 'dairy and sweetened beverages' dietary pattern as compared to the reference group. Conclusions: a dietary pattern characterized by a high intake of full-fat dairy and sweetened beverages was associated with higher A1c levels and increased risk of high glucose and BMI when compared to a dietary pattern with a higher consumption of fruits and vegetables.
INTRODUCCIÓN: Objetivo: el objetivo de este estudio fue identificar los patrones dietéticos de una muestra de pacientes con diabetes de tipo 2 y evaluar su asociación con los marcadores de control metabólico. Métodos: se realizó un estudio transversal de 395 pacientes con diabetes de tipo 2 en atención primaria. Se estimaron los niveles de hemoglobina glicosilada (A1c), glucosa, colesterol total, colesterol de lipoproteínas de baja (LDL-c) y alta densidad (HDL-c), y triglicéridos en ayunas. Se evaluaron el perímetro de la cintura, el índice de masa corporal (IMC) y la presión arterial. La ingesta dietética se evaluó mediante un cuestionario de frecuencia de alimentos y los patrones dietéticos se obtuvieron mediante un análisis de conglomerados. Se identificaron tres patrones dietéticos: "frutas y verduras", "lácteos y bebidas azucaradas" y "diversos con alcohol". Resultados: se identificó una asociación entre el patrón dietético de "productos lácteos y bebidas azucaradas" y los niveles de A1c (ß = 0,61; IC del 95 %: 0,09, 1,12, p = 0,021), considerando el patrón dietético de "frutas y verduras" como grupo de referencia. También se observó una tendencia a un mayor riesgo ajustado de A1c ≥ 7 % (odds ratio [OR]: 1,56; IC del 95 %: 0,92, 2,64; p = 0,099) y un mayor riesgo de IMC ≥ 25 kg/m2 (OR: 2,62; IC del 95 %: 1,20, 5,71, p = 0,015) entre los pacientes del patrón "lácteos y bebidas azucaradas" en comparación con el grupo de referencia. Conclusiones: el patrón dietético caracterizado por un alto consumo de lácteos y bebidas azucaradas se asoció con niveles más altos de A1c y un mayor riesgo de elevación de la glucosa y el IMC, en comparación con un patrón dietético con mayor consumo de frutas y verduras.