Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial.

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.

Frequency of Intradialytic Hypotension Events Do Not Increase with Oral Nutritional Supplementation during Hemodialysis Treatment: A Randomized Controlled Trial.

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.

Development of an online tool for sodium intake assessment in Mexico.

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.

Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF).

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.

Salt in the diet in patients with heart failure: what to recommend.

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.

The long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failure. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure): a pilot study.

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.

Estimates of Dietary Sodium Consumption in Patients With Chronic Heart Failure.

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.

Association between self-reported adherence to a low-sodium diet and dietary habits related to sodium intake in heart failure patients.

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.

Maternal Underestimation of Child's Weight Status and Health Behaviors as Risk Factors for Overweight in Children.

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.

The current state of evidence for sodium and fluid restriction in heart failure.

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.

Dichotomous effect of dietary fiber in pediatrics: a narrative review of the health benefits and tolerance of fiber.

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.

Utilizing Quality of Life Adjusted Days Alive and Out of Hospital in Heart Failure Clinical Trials.

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.

Association between BMI z-score and body composition indexes with blood pressure and grip strength in school-age children: a cross-sectional study.

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.

Genetic Determinants of Atherogenic Indexes.

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.

Sodium Restriction in Patients With Heart Failure: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

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.

The Need for Fiber Addition in Symptomatic Heart Failure (FEAST-HF): A Randomized Controlled Pilot Trial.

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.

Serum Asprosin Concentrations in Children with Prader-Willi Syndrome: Correlations with Metabolic Parameters.

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.

Functional improvement in individuals with chronic spinal cord injury treated with 4-aminopyridine: A systematic review.

Study design: Systematic review. Objective: To provide current evidence on the efficacy of 4-aminopyridine (4-AP) to bring about functional improvement in individuals with chronic traumatic spinal cord injury (SCI). Methods: The Medline (PubMed), Web of Science and SCOPUS databases were systematically searched for relevant articles on the efficacy of 4-AP to treat SCI, from the dates such articles were first published until May 2022. Full-text versions of all the articles selected were examined independently by two reviewers. Methodological quality was rated using the Modified Jadad Scale, and risk of bias was assessed with the RoB-2 test. Data extracted included human models/types, PRISMA assessment protocols, and the results of each study. Descriptive syntheses are provided. Results: In total, 28 articles were initially identified, 10 of which were included after screening. Most of the studies reviewed reported some degree of patient improvement in one or more of the following parameters: motor, sensitivity and sexual function, sphincter control, spasticity, ability to function independently, quality of life, central motor conduction, pain, and pulmonary function. Conclusions: This review confirms the efficacy of 4-AP in improving several conditions resulting from SCI but further research on this topic is warranted. Additional randomized clinical trials with 4-AP involving larger sample sizes are needed, as are consistent outcome measures in order to obtain adequate data for analysis with a view to enhance treatment benefits. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=334835, PROSPERO CRD42022334835.

Adherence to non-pharmacological treatment is associated with the goals of cardiovascular control and better eating habits in Mexican patients with type 2 diabetes mellitus. / La adherencia al tratamiento no farmacológico se asocia con metas de control cardiovascular y mejores hábitos dietéticos en pacientes mexicanos con diabetes mellitus tipo 2.

OBJECTIVE: To identify the association of diabetes education or medical nutrition therapy with the goals of control of cardiovascular risk indicators and dietary habits in patients with type 2 diabetes mellitus. METHODS: Analytical cross-sectional study in 395 primary care patients. HbA1c, fasting glucose and lipid profile, blood pressure, weight, waist circumference, and body composition were measured. Dietary habits were measured using the «Instrument for measuring lifestyle in patients with type 2 diabetes mellitus¼ (IMEVID), in the nutrition dimension. Medical nutrition therapy (MNT) and diabetes education (DE) were considered as received by the patient when provided in their healthcare clinic. RESULTS: Women comprised 68% of the patients, with a median of 6 years from diabetes diagnosis. Of the patients, 21% received DE and MNT, 28% DE or MNT, and 51% received neither. The HbA1c was lower in the patients with DE and MNT (7.7% ± 1.9% vs. 8.7% ± 2.3%, 8.4% ± 2.2%; p = .003) respectively. In the patients with DE and MNT, a higher proportion took physical exercise, consumed less tobacco, and had better dietary habits (p < .05). Patients who received DE and MNT achieved HbA1c and HDL-c control levels. A greater risk of HbA1c > 7% was identified when they only received DE or MNT or neither, a longer time since diagnosis of the disease and less frequent adherence to a diet to control the disease (p < .05). CONCLUSION: Diabetes education and medical nutritional therapy favour the goal of cardiovascular risk control and better dietary habits in the patient with type 2 diabetes.

A dietary pattern high in full-fat dairy and sweetened beverages is associated with glycated hemoglobin and weight in Mexican patients with type-2 diabetes.

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.