Adiposity and insulin resistance mediate the inverse association between legume intake and blood pressure: a cross-sectional analysis in secondary cardiovascular prevention.

This study aimed to evaluate the association between legume intake and blood pressure, as well as the mediating role of cardiometabolic risk factors in patients in secondary cardiovascular prevention. Socio-demographic, anthropometric, clinical and food intake data were collected from the baseline of the multicentre study Brazilian Cardioprotective Nutritional Program Trial - BALANCE (RCT: NCT01620398). The relationships between variables were explored through path analysis. In total, 2247 individuals with a median age of 63·0 (45-91) years, 58·8 % (n 1321) male and 96·5 % (n 2168) with diagnosis of hypertension were included. Negative associations were observed between histidine intake and systolic blood pressure (SBP) (standardised coefficient (SC) = -0·057; P = 0·012) and between legume intake and BMI (SC = -0·061; P = 0·006). BMI was positively associated with triglycerides-glucose (TyG) index (SC = 0·173; P < 0·001), SBP (SC = 0·144; P < 0·001) and diastolic blood pressure (DBP) (SC = 0·177; P < 0·001), and TyG index was positively associated with DBP (SC = 0·079; P = 0·001). A negative indirect effect was observed between the intake of legumes, SBP and DBP, mediated by BMI (SC = -0·009; P = 0·011; SC = -0·011; P = 0·010, respectively). In addition, an indirect negative effect was found between the intake of legumes and the DBP, mediated simultaneously by BMI and TyG index (SC = -0·001; P = 0·037). In conclusion, legume intake presented a negative indirect association with blood pressure, mediated by insulin resistance (TyG) and adiposity (BMI) in individuals of secondary care in cardiology.

Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial.

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 (DIeta CArdioprotetora Brasileira, 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.

Ultra-processed foods consumption is associated with cardiovascular disease and cardiometabolic risk factors in Brazilians with established cardiovascular events.

The consumption of ultra-processed foods (UPF) has been associated with cardiometabolic risk factors. However, there is scarce literature on the association between UPF consumption, cardiovascular events, and cardiometabolic risk factors in subjects undergoing secondary care for cardiovascular diseases (CVD). Thus, we aimed to evaluate the association between UPF consumption, CVD, and cardiometabolic risk factors in subjects with established CVD. Baseline data from 2,357 subjects participating in a Brazilian multicenter study were analysed finding a mean UPF consumption of 18.7% of their energy intake. Higher figures of UPF consumption were founded associated with an increased presence of high waist circumference, overweight, peripheral arterial disease, and with a decreased odds of the simultaneous presence of coronary arterial disease, peripheral arterial diseases, and stroke when comparing among tertiles of UPF contribution to energy intake. These associations were observed when analyzing the whole sample and women but not men. Thus, these findings should help improve strategies for CVD patients in secondary care.

Dietary total antioxidant capacity is inversely associated with cardiovascular events and cardiometabolic risk factors: A cross-sectional study.

OBJECTIVES: Dietary total antioxidant capacity (dTAC) has been introduced as a useful tool to quantify the antioxidant content of a diet. However, few studies have evaluated the association of dTAC with cardiovascular disease (CVD) occurrence and cardiometabolic risk factors in people with established CVD events. Thus, we aimed to investigate the presence of an association between dTAC values, cardiovascular events, and cardiometabolic risk factors in individuals with previous CVD in a Brazilian multicenter study. METHODS: This study has a cross-sectional design. We evaluated baseline data from the Brazilian Cardioprotective Nutritional Program Trial. Sociodemographic, anthropometric, clinical, and food-consumption data were collected in face-to-face interviews. We estimated dTAC from the mean of two 24-h dietary recalls by values of ferric-reducing antioxidant power. RESULTS: We evaluated 2346 participants, most of whom were men (58.4%), older adults (64.2%), and overweight (68.6%), and had coronary artery disease (92.4%). The mean dTAC was equal to 5.6 (interquartile range, 3.9-7.8) mmol/1000 kcal. Participants in the third dTAC tertile (9.2 mmol/1000 kcal) had a 22%, 59%, and 69% lower chance, respectively, of having hypertriglyceridemic waist phenotype, abdominal aortic aneurysm, and amputation due to arterial disease in comparison to the first tertile (3.4 mmol/1000 kcal). CONCLUSIONS: The dTAC was inversely associated with hypertriglyceridemic waist phenotype, abdominal aortic aneurysm, and amputation due to arterial disease in individuals undergoing secondary care for CVD. Our results can guide strategies for the prevention of new CVD and its consequences.

Pro-inflammatory diet is associated with a high number of cardiovascular events and ultra-processed foods consumption in patients in secondary care.

OBJECTIVE: To evaluate the association of dietary inflammatory index (DII®) with the occurrence of cardiovascular events, cardiometabolic risk factors and with the consumption of processed, ultra-processed, unprocessed or minimally processed foods and culinary ingredients. DESIGN: This was a cross-sectional study that analysed the baseline data from 2359 cardiac patients. Data on socio-demographic, anthropometric, clinical and food consumption were collected. Energy-adjusted food intake data were used to calculate DII, and the foods were classified according to the NOVA classification. Furthermore, the patients were grouped according to the number (1, 2 or ≥ 3) of manifested cardiovascular events. The data were analysed using linear and multinomial logistic regression. SETTINGS: Multicentre study from Brazil. PARTICIPANTS: Patients with established cardiovascular events from the Brazilian Cardioprotective Nutritional Program Trial evaluated at baseline. RESULTS: Most of the patients were male (58·8 %), older adults (64·2 %) and were overweight (68·8 %). Patients in the third tertile of DII (DII > 0·91) had were more likely to have 2 (OR 1·27, 95 % CI: 1·01-1·61) and ≥ 3 (OR 1·39, 95 % CI: 1·07-1·79) cardiovascular events, with poor cardiometabolic profile. They also were more likely to consume a higher percentage of processed, ultra-processed and culinary ingredients foods consumption compared with the patients in the first DII tertile (DII ≤ 0·91). CONCLUSION: A more pro-inflammatory diet is associated with a greater chance of having 2 and ≥ 3 cardiovascular events and cardiometabolic risk factors and were more likely to consume processed, ultra-processed and culinary ingredients compared to those with a more anti-inflammatory diet.

Mindfulness Practice for Glycemic Control: Could it be a New Strategy for an Old Problem? A Systematic Review and Meta-Analysis.

BACKGROUND: The management of type 2 diabetes mellitus (T2DM) requires a complex and organized care that includes patient's lifestyle change. Additionally, emotional well-being is an important part of self-management, and it may impair the individual's adherence. Therefore, equipping the patients with the necessary coping and self-care techniques may be an important step in managing diabetes. OBJECTIVE: To evaluate the effect of interventions using established mindfulness-based protocols on glycemic control of individuals with T2DM. METHODS: Data sources: Two electronic databases (PubMed and EMBASE) were searched from inception to December 2019. We limited our search to published studies in English, Spanish and Portuguese languages. STUDY SELECTION: Randomized clinical trials that assessed the effects of mindfulness in individuals with T2DM were selected. DATA EXTRACTION: Two authors independently assessed the risk of bias and extracted data from the included trials. Data were pooled using inverse-variance random-effects meta-analyses. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Four randomized trials were included. There were no differences in blood glucose change (mean difference between groups (MD) -0.73mg/dl; 95% CI, -10.49; 9.02; I2 =0%; very low quality of evidence) or glycated hemoglobin (MD 0.05%; 95%CI -0.22 to 0.32; I2 =29%; very low quality of evidence). CONCLUSION: Although the quality of current evidence is very low, our findings suggest that established protocols involving mindfulness have no effect on blood glucose or glycated hemoglobin in individuals with T2DM. Indeed, large-scale trials are needed to evaluate the contribution of mindfulness to glycemic control in clinical practice. PROSPERO Registration ID: RD42020161940.

Análise de custo-efetividade do Programa Alimentar Brasileiro Cardioprotetor (BALANCE): um estudo clínico randomizado, multicêntrico em indivíduos com doença cardiovascular / Cost-effectiveness analysis of the Brazilian Cardioprotective Diet Program (BALANCE): a randomized, multicenter clinical study in individuals with cardiovascular disease

O padrão alimentar associado à redução da mortalidade e de fatores de risco para doença cardiovascular inclui ingestão adequada de cereais integrais, frutas, leguminosas, legumes, nozes, sementes, peixe e consumo reduzido de carne vermelha e carne processada. Embora essa recomendação seja a melhor evidência do efeito benéfico entre dieta e doença coronariana, profissionais da saúde devem considerar que a disponibilidade e acessibilidade dos alimentos. O programa alimentar brasileiro cardioprotetor (BALANCE) é um estudo clínico randomizado que propõe a adoção de uma dieta com potencial cardioprotetor e acessível à população brasileira. Outras propostas de dietas cardioprotetoras foram feitas ao redor do mundo e mostraram ser eficazes na prevenção das doenças cardiovasculares e redução da mortalidade. No entanto, quando implementadas fora dos países de origem tornam-se impraticáveis pela baixa acessibilidade e adaptação cultural. Esta tese será apresentada sob a forma de três artigos científico. No primeiro foi realizada uma análise transversal do início do estudo BALANCE sobre o custo direto com despesas diárias alimentares e a qualidade da dieta. Não foi observada associação entre o custo direto e o índice de qualidade da dieta revisado (IQD-R), assim como não foi observada diferença entre a adesão aos escores do IQD-R. O segundo artigo realizou uma análise de custo-efetividade da alimentação adotada pelos participantes com maior adesão ao protocolo ao longo de 36 meses. Foram considerados apenas despesas diárias para a compra dos alimentos e a efetividade foi medida pelo IQD-R. Na linha de base, os custos médios foram iguais (U$ 3,9/dia) e o IQD-R foi de 53,5 e 51,8 pontos no nos grupos BALANCE e controle, respectivamente. Após um período de três anos, a intervenção foi associada a uma economia de custo média de US $ 0,31/dia (IC 95%: -0,59; -0,44) e um aumento médio do IQD-R de 4,38 (IC 95%: 2,81; 5,95). O terceiro artigo analisou o custo-efetividade do estudo BALANCE em todos os participantes, utilizando a perspectiva da sociedade e um horizonte temporal de 36 meses. Foram considerados custos diretos médicos (hospitalizações, procedimentos e exames) e custos diretos não médicos (gastos do paciente). Após 36 meses, a diferença no custo total entre as intervenções foi de -R$ 151,9 (IC 95%: -R$ 493,3; R$ 190,50). A dieta adotada pelo grupo BALANCE foi associada a uma economia média de R$ 415,53 (IC95% -687,79; -139,78). A diferença em LYs foi de 0,011 anos (IC 95%: -0,025; 0,046) de LYGs. A relação custo-efetividade incremental foi - R$ 14.098,63 por LYG (IC 95%: -156.178; 154.864). A análise de custo-efetividade do estudo BALANCE mostrou neutralidade em relação ao grupo controle. No entanto, o custo com a dieta adotada no grupo BALANCE foi menor ao longo do tempo e a melhor qualidade da dieta não se associou a maior despesa com alimentos. Esses achados podem estimular a adesão e recomendações da estratégia de educação nutricional BALANCE em um cenário de saúde pública.

The dietary pattern associated with reduced mortality and risk factors for cardiovascular disease includes adequate intake of whole grains, fruits, legumes, vegetables, nuts, seeds, fish and reduced consumption of red meat and processed meat. Although this recommendation is the best evidence of the beneficial effect between diet and coronary heart disease, healthcare professionals should consider food availability and accessibility. The Brazilian Cardioprotective Nutritional Program Trial (BALANCE Program) is a randomized clinical study that proposed a cardiovascular-protector diet suited for the Brazilian population. Other cardiovascular protector diets were implemented outside of Brazil and were shown to be effective for the prevention of cardiovascular diseases and the reduction of mortality rates, but became unfeasible when implemented outside their countries. This thesis is presented in the form of three papers. In the first, a cross-sectional analysis of the BALANCE trial baseline was performed, considering the direct cost of daily food expenses and the quality of the diet. There was no association between direct cost and Brazilian Health Eating Index Revised (BHEI-R), as well as with adherence to BHEI-R scores. The second article carried out a cost-effectiveness analysis of the food adopted by the participants with greater adherence to the protocol over 36 months. Only daily expenses for the purchase of food were considered, and effectiveness was measured by the BHEI-R. At baseline, the average costs were equal (U$3.9/day), and BHEI-R were 53·5 and 51·8 points, in the BALANCE Program and control groups, respectively. After a three-year period, the intervention was associated with an average cost saving of U$0·31/day (95%CI: -0·59; -0·04) and an average increase of BHEI-R of 4·38 (95%CI: 2·81; 5·95). The third article analyzed the cost-effectiveness of the BALANCE study with all participants, using the perspective of the society and a 36-month time horizon. Direct medical costs (hospitalizations, procedures and examinations), direct non-medical costs (patient expenses) and indirect costs (deaths) were considered. After 36 months, difference in total interventions cost was -R$151.9 (CI 95%: -R$ 493.3; R$190.50). The diet adopted by BALANCE group was associated with a mean cost saving of R$415.53 (CI95% -687.79; -139.78). Difference in LYs was 0.011 years (CI 95%: -0.025; 0.046) of LYGs. The incremental cost-effectiveness ratio was - R$ 14.098,63 per LYG (CI95%: -156.178; 154.864). Cost-effectiveness analysis from the BALANCE study showed neutrality compared to the control group. However, diet adopted in the BALANCE group saved money over time and better diet quality was not associated with higher food expenditure. This finding may encourage the adherence and recommendations of BALANCE nutritional education strategy in a public health scenario.

[Quality of diet and daily spending on food by adults with cardiovascular disease in Brazil]. / Qualidade da dieta e despesa diária com alimentação em adultos com doença cardiovascular no Brasil.

Adherence to a healthy diet depends on factors such as food prices, while studies in developed countries have identified higher costs of more nutritional foods. The current study aimed to assess the direct food expenditures by adults with cardiovascular disease in Brazil, investigating the relationship between cost and quality of diet. The study used data from a randomized clinical trial, the BALANCE Program. The current study is a cross-sectional baseline analysis of participants with high adherence to the trial, conducted in 35 sites in all five major geographic regions of Brazil. Food consumption by 1,160 individuals was collected with a 24-hour dietary recall (24HR), quality of diet was measured with the Diet Quality Index Revised (DQI-R), and direct food costs were estimated from market prices. No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics. When all the 24HR were analyzed, there was no correlation between cost and quality of diet (r = 0.38; p = 0.17), while analysis by tertiles showed a weak correlation in the lowest tertile of adherence (r = -0.112; p = 0.03). The study showed absence of differences between direct costs of healthy versus unhealthy foods, a finding that can serve as an incentive for adherence to food recommendations in Brazil, thereby minimizing barriers to the adoption of healthy lifestyles.

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.

La adhesión a una alimentación saludable depende de factores como los precios de los alimentos, siendo que algunos estudios realizados en países desarrollados apuntan hacia un mayor coste de una alimentación de mejor calidad nutricional. El objetivo del presente estudio fue evaluar el coste directo de la alimentación en individuos adultos con enfermedad cardiovascular en Brasil, investigando la relación entre el coste y la calidad de la dieta. Se utilizaron los datos de un ensayo clínico aleatorio, el BALANCE Program. La investigación actual es un análisis transversal desde el principio con participantes de alta adhesión al estudio, realizado en 35 centros de las cinco regiones brasileñas. El consumo alimentario de la muestra con 1.160 individuos fue recogido mediante el recordatorio alimentario de 24 horas (R24h), la evaluación de la calidad de la dieta se evaluó mediante el Índice de Calidad de la Dieta Revisado (IQD-R por sus siglas en portugués) y los costes directos de la alimentación se estimaron mediante precios de mercado. No se observaron diferencias significativas en el coste directo de la alimentación o características de los individuos entre los terciles de adhesión. Cuando se analizaron todos los recordatorios no hubo correlación entre coste y calidad de la dieta (r = 0,38; p = 0,17), ya en el análisis por terciles hubo una débil correlación entre el menor tercil de adhesión (r = -0,112; p = 0,03). El presente estudio apuntó una ausencia de diferencias entre los costes directos de la alimentación clasificada como saludable y aquella con peor calidad nutricional, lo que puede ser un incentivo para la adhesión a las orientaciones alimentarias en Brasil, minimizando barreras para la adopción de estilos de vida saludables.

Qualidade da dieta e despesa diária com alimentação em adultos com doença cardiovascular no Brasil / Quality of diet and daily spending on food by adults with cardiovascular disease in Brazil / Calidad de la dieta y gasto diario en alimentación de adultos con enfermedad cardiovascular en Brasil

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.

Adherence to a healthy diet depends on factors such as food prices, while studies in developed countries have identified higher costs of more nutritional foods. The current study aimed to assess the direct food expenditures by adults with cardiovascular disease in Brazil, investigating the relationship between cost and quality of diet. The study used data from a randomized clinical trial, the BALANCE Program. The current study is a cross-sectional baseline analysis of participants with high adherence to the trial, conducted in 35 sites in all five major geographic regions of Brazil. Food consumption by 1,160 individuals was collected with a 24-hour dietary recall (24HR), quality of diet was measured with the Diet Quality Index Revised (DQI-R), and direct food costs were estimated from market prices. No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics. When all the 24HR were analyzed, there was no correlation between cost and quality of diet (r = 0.38; p = 0.17), while analysis by tertiles showed a weak correlation in the lowest tertile of adherence (r = -0.112; p = 0.03). The study showed absence of differences between direct costs of healthy versus unhealthy foods, a finding that can serve as an incentive for adherence to food recommendations in Brazil, thereby minimizing barriers to the adoption of healthy lifestyles.

La adhesión a una alimentación saludable depende de factores como los precios de los alimentos, siendo que algunos estudios realizados en países desarrollados apuntan hacia un mayor coste de una alimentación de mejor calidad nutricional. El objetivo del presente estudio fue evaluar el coste directo de la alimentación en individuos adultos con enfermedad cardiovascular en Brasil, investigando la relación entre el coste y la calidad de la dieta. Se utilizaron los datos de un ensayo clínico aleatorio, el BALANCE Program. La investigación actual es un análisis transversal desde el principio con participantes de alta adhesión al estudio, realizado en 35 centros de las cinco regiones brasileñas. El consumo alimentario de la muestra con 1.160 individuos fue recogido mediante el recordatorio alimentario de 24 horas (R24h), la evaluación de la calidad de la dieta se evaluó mediante el Índice de Calidad de la Dieta Revisado (IQD-R por sus siglas en portugués) y los costes directos de la alimentación se estimaron mediante precios de mercado. No se observaron diferencias significativas en el coste directo de la alimentación o características de los individuos entre los terciles de adhesión. Cuando se analizaron todos los recordatorios no hubo correlación entre coste y calidad de la dieta (r = 0,38; p = 0,17), ya en el análisis por terciles hubo una débil correlación entre el menor tercil de adhesión (r = -0,112; p = 0,03). El presente estudio apuntó una ausencia de diferencias entre los costes directos de la alimentación clasificada como saludable y aquella con peor calidad nutricional, lo que puede ser un incentivo para la adhesión a las orientaciones alimentarias en Brasil, minimizando barreras para la adopción de estilos de vida saludables.

Triglyceride-glucose index is associated with symptomatic coronary artery disease in patients in secondary care.

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.

Development of a dietary index based on the Brazilian Cardioprotective Nutritional Program (BALANCE).

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 < 0,05). The components of the index showed low correlations with each other. The correlations between each individual component with the total index were > 0.40. Cronbach's alpha coefficient was 0.66. High scores in the index were inversely associated (p < 0,05) with energy, total fat, monounsaturated fat (MUFA) and cholesterol; they were positively associated (p < 0,05) with carbohydrates and fiber. Hypertensive men and diabetic women had higher scores, while male smokers had lower scores. CONCLUSIONS: The BALANCE DI showed reliability and construct validity similar to other DI. It also detected characteristics of individuals that are associated with higher or lower index scores.

Association between plasma fatty acids and inflammatory markers in patients with and without insulin resistance and in secondary prevention of cardiovascular disease, a cross-sectional study.

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)-1ß, 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 < 0.05). Among those with insulin resistance there was a positive association between monounsaturated fatty acids and arachidonic fatty acid and adiponectin (p < 0.05), and a negative association between monounsaturated and polyunsaturated fatty acids and pro-inflammatory biomarkers (p < 0.05), as well as a negative association between polyunsaturated fatty acids and adiponectin (p < 0.05). Our study has not found any association between hs-CRP and plasma fatty acids. CONCLUSIONS: Subjects in secondary prevention for cardiovascular disease with insulin resistance have a higher concentration of hs-CRP and IL-6 than individuals without insulin resistance, and these inflammatory biomarkers are positively associated with saturated fatty acids and negatively associated with unsaturated fatty acids.

Association between plasma fatty acids and inflammatory markers in patients with and without insulin resistance and in secondary prevention of cardiovascular disease, a cross-sectional study

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)-1ß, 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 < 0.05). Among those with insulin resistance there was a positive association between monounsaturated fatty acids and arachidonic fatty acid and adiponectin (p < 0.05), and a negative association between monounsaturated and polyunsaturated fatty acids and pro-inflammatory biomarkers (p < 0.05), as well as a negative association between polyunsaturated fatty acids and adiponectin (p < 0.05). Our study has not found any association between hs-CRP and plasma fatty acids.

Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension).

BACKGROUND: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. METHODS: In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; P<0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; P=0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. CONCLUSIONS: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

Effects of bariatric surgery in obese patients with hypertension: the GATEWAY randomized trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension)

BACKGROUND: Recent research efforts on bariatric surgery have focusedon metabolic and diabetes mellitus resolution. Randomized trials designedto assess the impact of bariatric surgery in patients with obesity andhypertension are needed.METHODS: In this randomized, single-center, nonblinded trial, we includedpatients with hypertension (using ≥2 medications at maximum doses or >2 atmoderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patientswere randomized to Roux-en-Y gastric bypass plus medical therapy or medicaltherapy alone. The primary end point was reduction of ≥30% of the totalnumber of antihypertensive medications while maintaining systolic and diastolicblood pressure <140 mmHg and 90 mmHg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years,mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up.Reduction of ≥30% of the total number of antihypertensive medicationswhile maintaining controlled blood pressure occurred in 41 of 49 patientsfrom the gastric bypass group (83.7%) compared with 6 of 47 patients(12.8%) from the control group with a rate ratio of 6.6 (95% confidenceinterval, 3.1–14.0; P<0.001). Remission of hypertension was present in 25of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass,considering office and 24-hour ambulatory blood pressure monitoring...

The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease.

Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial

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.

Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial.

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.