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Abstract Background Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DI eta CA rdioprotetora Br asileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI). Methods DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data. Discussion It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br. Trial registration ClinicalTrials.gov Identifier NCT03728127 . First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.

The American Heart Association (AHA) has developed the concept of “ideal cardiovascular health” (ICH), a seven-component score, which includes health dietary metrics. Higher ultra-processed foods intake is related with several cardiometabolic and cardiovascular diseases. We propose to develop and validate the Cardiovascular Health Diet Index (CHDI), a diet quality index that combines the AHA's recommendations of a healthy diet for cardiovascular health and ultra-processed foods. We used dietary data obtained through a 114-item FFQ from 14,779 participants of the Brazilian Longitudinal Study of Adults Health (ELSA-Brasil). The CHDI had 11 components and a total score ranging from 0 to 110 points. Validation and reliability analyses were performed, including principal component analyses, association with selected nutrients, means differences between groups (for example, smokers vs. non-smokers), Cronbach's alpha, and linear regression analyses between CHDI and overall dietary quality. The mean CHDI was 57.1 points (95% CI 47.9:66.0). The CHDI had four dimensions; in addition, it was associated with nutrients related to cardiovascular health, and the points were significantly (p < 0.001) lower in smokers (52.1) than in non-smokers (57.8). Cronbach's alpha value was 0.50. After age and sex adjustment, the CHDI score remained associated with a higher overall dietary quality (β 0.87, 95%CI 0.84:0.89, p < 0.001). The CHDI proved to be valid and reliable for use, in addition to being associated with higher overall dietary quality. The use of CHDI is expected to assess the population's compliance with dietary recommendations for promoting cardiovascular health and preventing cardiovascular disease.

OBJECTIVE: To evaluate the effectiveness of the Brazilian Cardioprotective Diet Program in reducing blood pressures, fasting glucose levels and body mass indices in patients with established atherothrombotic disease. METHOD: This randomized controlled pilot trial included outpatients who were over 45 years of age with atherothrombotic cardiovascular disease. Group A, who received the Brazilian Cardioprotective Diet Program, had weekly sessions with dietitians. Groups B and C received the usual dietary therapy that is given to patients with cardiovascular diseases as proposed by the Brazilian guidelines. This diet had the same nutrient profile as that given to Group A, but it was customized by the integration of typical Mediterranean foods. The difference between Groups B and C was the number of sessions with the dietitian. Group B received weekly sessions, while group C only had monthly sessions. ClinicalTrials.gov: NCT 01453166. RESULTS: There was a greater reduction in systolic (7.8%) and diastolic (10.8%) blood pressures in Group A compared with Group B (2.3% and 7.3%), and Group C (3.9% and 4.9%, respectively). Fasting glucose decreased by 5.3% and 2% in Groups A and B, respectively. Fasting glucose increased by 3.7% in Group C. The BMIs decreased by 3.5% and 3.3% in Groups A and B, respectively. Group C did not present with any changes in BMI. However, none of these data showed statistical differences between the groups, which is methodologically acceptable in pilot trials. CONCLUSIONS: The Brazilian Cardioprotective Diet Program seems to be more effective in reducing blood pressures, fasting glucose levels, weights and BMIs in patients with previous cardiovascular disease compared with the diet that has been proposed by the Brazilian guidelines.

Abstract Background Nuts consumption is related to cardioprotective effects on primary cardiovascular prevention, but studies conducted in secondary prevention are small, scarce and controversial. The objective of this trial was to evaluate the effects of a regional and sustainable cardioprotective diet added or not with an affordable mixed nuts on cardiometabolic features in patients with previous myocardial infarction. Methods DICA-NUTS study is a national, multi-center, and superiority-parallel randomized clinical trial. Males and females over 40 years old diagnosed with previous myocardial infarction in the last 2 to 6 months were included. Patients were allocated into two groups: the Brazilian Cardioprotective diet (DICA Br) supplemented with 30 g/day of mixed nuts (10 g of peanuts; 10 g of cashew; 10 g of Brazil nuts) (intervention group, n = 193); or only DICA Br prescription (control group, n = 195). The primary outcome was low-density lipoprotein cholesterol means (in mg/dL) after 16 weeks. Secondary outcomes were other lipid biomarkers, glycemic and anthropometric data and diet quality. Results After adjustment for baseline values, participating study site, time since myocardial infarction and statin treatment regimen (high potency, moderate and low potency/no statins), no significant difference was found between the groups in low-density lipoprotein cholesterol concentrations (intervention-control difference: 3.48 mg/dL [-3.45 to 10.41], P = 0.32). Both groups improved their overall diet quality at the end of the study without differences between them after 16 weeks (intervention-control difference: 1.05 (-0.9 to 2.99); P = 0.29). Other lipids, glycemic profile and anthropometrics were also not different between study groups at the end of the study. Conclusion Adding 30 g/day of mixed nuts to the DICA Br for 16 weeks did not change lipid, glycemic and anthropometric features in the post-myocardial infarction setting. Trial registration This study is registered on ClinicalTrials.gov website under number NCT03728127 and its World Health Organization Universal Trial Number (WHO-UTN) is U1111-1259–8105.

Summary: Background and aims: A healthy diet is one of the pillars of familial hypercholesterolemia (FH) treatment. However, the best dietary pattern and indication for specific supplementation have not been established. Our aim is to conduct a pilot study to assess the effect of an adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in participants with a probable or definitive diagnosis of FH, treated with moderate/high potency statins. Methods: A national, multicenter, factorial, and parallel placebo-controlled randomized clinical trial with a superiority design and 1:1:1:1 allocation rate will be conducted. The participants will undergo whole exome sequencing and be allocated into four treatment groups: 1) a cardioprotective diet adapted for FH (DICA-FH) + phytosterol placebo + krill oil placebo; 2) DICA-FH + phytosterol 2 g/day + krill oil placebo; 3) DICA-FH + phytosterol placebo + krill oil 2 g/day; or 4) DICA-FH + phytosterol 2 g/day + krill oil 2 g/day. The primary outcomes will be low-density lipoprotein (LDL)-cholesterol and lipoprotein (a) levels and adherence to treatment after a 120-day follow-up. LDL- and high-density lipoprotein (HDL)-cholesterol subclasses, untargeted lipidomics analysis, adverse events, and protocol implementation components will also be assessed. Results: A total of 58 participants were enrolled between May–August 2023. After the end of the follow-up period, the efficacy and feasibility results of this pilot study will form the basis of the design of a large-scale randomized clinical trial. Conclusions: This study's overall goal is to recommend dietary treatment strategies in the context of FH.

Resumo Fundamento Alcançar as metas nutricionais estabelecidas pelas sociedades científicas é um desafio constante e nem sempre alcançado. Objetivo Investigar a adequação alimentar de indivíduos com doença cardiovascular (DCV), participantes do Programa Alimentar Brasileiro Cardioprotetor residentes da região Nordeste do Brasil, segundo as recomendações da Sociedade Brasileira de Cardiologia (SBC). Métodos Análise transversal com dados do estudo de implementação da Dieta Cardioprotetora Brasileira (DICA BR) que avaliou indivíduos com DCV, atendidos em centros especializados em saúde cardiovascular em oito estados do Nordeste. O consumo alimentar foi obtido por recordatório alimentar de 24 horas e a adequação da dieta seguiu as recomendações da SBC. Foram considerados significantes valores de p < 0,05. Resultados Foram estudados 647 pacientes, com média (desvio padrão) de idade de 63,1 (9,4) anos, sendo 50,2% do sexo feminino. Na avaliação da ingestão alimentar, observou-se baixa adequação de carboidratos (52,3%), proteínas (70,9%), lipídios (38,8%) e fibras (22,4%). Observou-se que a maioria das mulheres consumia dieta hipoproteica (59,2%) e idosos tinham maior inadequação no consumo de carboidratos (52,6%). Em relação a ingestão de sódio, os homens apresentaram maior ingestão (72,9%), enquanto os idosos apresentaram redução de 13%. Além disso, foi demonstrado que os homens ingeriam mais fibras (28,1%) e indivíduos com maior escolaridade tinham um consumo elevado de ácidos graxos saturados (70,5%). Conclusões A maioria dos indivíduos não alcançou as metas dietoterápicas preconizadas para prevenção cardiovascular secundária. Os achados do presente estudo reforçam a necessidade de implementação de estratégias estruturadas, a fim de estimular hábitos alimentares saudáveis nesses indivíduos.

Resumo Fundamento: A adesão à uma alimentação adequada em macronutrientes é fundamental para a prevenção secundária de doenças cardiovasculares. Objetivo: Avaliar a prevalência de adesão às recomendações de consumo de ácidos graxos para prevenção e tratamento de doenças cardiovasculares, e estimar se a presença de determinados fatores de risco cardiovascular estaria associada à adesão. Métodos: Estudo transversal com os dados de linha de base de 2358 participantes do estudo "Brazilian Cardioprotective Nutritional Program Trial". Dados de consumo alimentar, e fatores de risco cardiovascular foram avaliados. Foi considerada, de acordo com a Sociedade Brasileira de Cardiologia, uma ingestão adequada de ácidos graxos poli-insaturados (AGPI) ≥10% do consumo total de energia diária, para ácidos graxos monoinsaturados (AGM), 20% e para ácidos graxos saturados (AGS),

Objectives: The objective of this study was to evaluate the effect of intercessory prayer performed by a group of spiritual leaders on the health outcomes of hospitalized patients with Novel Coronavirus (COVID-19) infection, specifically focusing on mortality and hospitalization rates. Design: This was a double-blinded, controlled, and randomized trial conducted at a private hospital in São Paulo, Brazil. Interventions: Both groups continued to receive their usual medical care in accordance with HCor Hospital's institutional patient care protocol for COVID-19 patients. Intervention: Both groups received their regular medical care according to HCor's institutional patient care protocol for COVID-19 patients. The intervention group, in addition to standard treatment, received intercessory prayers performed by a group of spiritual leaders. Main outcome measures: The primary endpoint was in-hospital mortality. Secondary endpoints included the need for mechanical ventilation during hospitalization, duration of mechanical ventilation, length of ICU stay, and length of hospital stay. Results: A total of 199 participants were randomly assigned to the groups. The primary outcome, in-hospital mortality, occurred in 8 out of 100 (8.0 %) patients in the intercessory prayer group and 8 out of 99 (8.1 %) patients in the control group (HR 0.86 [0.32 to 2.31]; p = 0.76). Additionally, there were no significant differences between the groups in terms of secondary outcomes. Conclusion: The study found no evidence of an effect of intercessory prayer on the primary outcome of mortality or on the secondary outcomes of hospitalization time, ICU time, and mechanical ventilation time.

Abstract Background The triglyceride-glucose index (TyG index) is a tool for insulin resistance evaluation, however, little is known about its association with coronary artery disease (CAD), which is the major cardiovascular death cause, and what factors may be associated with TyG index. Objective To evaluate the association between the TyG index and the prevalence of CAD phases, as well as cardiovascular risk factors. Methods The baseline data of patients in secondary care in cardiology from Brazilian Cardioprotective Nutritional Program Trial (BALANCE Program Trial) were analyzed. Anthropometric, clinical, socio-demographic and food consumption data were collected by trained professionals. The TyG index was calculated by the formula: Ln (fasting triglycerides (mg/dl) × fasting blood glucose (mg/dl)/2) and regression models were used to evaluate the associations. Results We evaluated 2330 patients, which the majority was male (58.1%) and elderly (62.1%). The prevalence of symptomatic CAD was 1.16 times higher in patients classified in the last tertile of the TyG index (9.9 ± 0.5) compared to those in the first tertile (8.3 ± 0.3). Cardiometabolic risk factors were associated with TyG index, with the highlight for higher carbohydrate and lower lipid consumption in relation to recommendations that reduced the chance of being in the last TyG index tertile. Conclusion The TyG index was positively associated with a higher prevalence of symptomatic CAD, with metabolic and behavioral risk factors, and could be used as a marker for atherosclerosis. Trial registration ClinicalTrials.gov identifier: NCT01620398. Registered 15 June, 2012

A adesão a uma alimentação saudável depende de fatores como os preços dos alimentos, sendo que alguns estudos conduzidos em países desenvolvidos apontam para um maior custo de uma alimentação de melhor qualidade nutricional. O objetivo do presente trabalho foi avaliar o custo direto da alimentação de indivíduos adultos com doença cardiovascular no Brasil, investigando a relação entre o custo e a qualidade da dieta. Foram utilizados os dados de um ensaio clínico randomizado, o BALANCE Program. A investigação atual é uma análise transversal no momento inicial dos participantes com alta adesão ao estudo realizado em 35 centros das cinco regiões brasileiras. O consumo alimentar de amostra com 1.160 indivíduos foi coletado pelo recordatório alimentar de 24 horas (R24h), a avaliação da qualidade da dieta pelo Índice da Qualidade da Dieta Revisado (IQD-R) e os custos diretos da alimentação foram estimados por meio de preços de mercado. Não foram observadas diferenças significativas no custo direto da alimentação ou características dos indivíduos entre os tercis de adesão. Quando analisados todos os recordatórios não houve correlação entre custo e qualidade da dieta (r = 0,38; p = 0,17), já a análise por tercis mostrou fraca correlação entre o menor tercil de adesão (r = -0,112; p = 0,03). O presente estudo apontou ausência de diferenças entre os custos diretos da alimentação classificada como saudável e daquela com a pior qualidade nutricional, o que pode ser um incentivo à adesão às orientações alimentares no Brasil, minimizando barreiras à adoção de estilos de vida saudáveis.

Abstract Background The diet of the Brazilian Cardioprotective Nutritional Program (BALANCE) classifies food into four groups and sets the daily amount to be consumed. The dietary approach of BALANCE is different from other dietary recommendations; therefore, it is not possible to use existing dietary indexes (DI) to assess patient’s adequacy to BALANCE diet. For this reason, it is important to develop a specific dietary index based on BALANCE diet. This study aims to describe the development of the BALANCE DI, evaluate its internal consistency, construct and content validity and population characteristics associated with the index. Methods We analyzed baseline data from the BALANCE randomized clinical trial (https://www.clinicaltrials.gov/; NCT01620398). The four food groups of the diet were adopted as index components. Points ranging from 0 to 10 were given to each index component. Internal consistency was evaluated by correlation coefficients between total score and component scores, as well as Cronbach’s Alpha. Content and construct validity were assessed by checking how nutrients are associated with the index and if the index could distinguish between groups with known differences in diet, respectively. Crude and adjusted linear regression analyses were performed to evaluate population characteristics associated with the index. Results The analysis included 2044 subjects (58.6% men). The average of the total index was higher among women (p 0.40. Cronbach’s alpha coefficient was 0.66. High scores in the index were inversely associated (p

Abstract Background Proinflammatory biomarkers levels are increased among patients with cardiovascular disease, and it is known that both the presence of insulin resistance and diet may influence those levels. However, these associations are not well studied among patients with established cardiovascular disease. Our objective is to compare inflammatory biomarker levels among cardiovascular disease secondary prevention patients with and without insulin resistance, and to evaluate if there is any association between plasma fatty acid levels and inflammatory biomarker levels among them. Methods In this cross-sectional sub-study from the BALANCE Program Trial, we collected data from 359 patients with established cardiovascular disease. Plasma fatty acids and inflammatory biomarkers (interleukin (IL)-1β, IL-6, IL-8, IL-10, IL-12, high sensitive C-reactive protein (hs-CRP), adiponectin, and tumor necrosis factor (TNF)-alpha) were measured. Biomarkers and plasma fatty acid levels of subjects across insulin resistant and not insulin resistant groups were compared, and general linear models were used to examine the association between plasma fatty acids and inflammatory biomarkers. Results Subjects with insulin resistance had a higher concentration of hs-CRP (p = 0.002) and IL-6 (p = 0.002) than subjects without insulin resistance. Among subjects without insulin resistance there was a positive association between stearic fatty acid and IL-6 (p = 0.032), and a negative association between alpha-linolenic fatty acid and pro-inflammatory biomarkers (p