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The effect of the a regional cardioprotective nutritional program on inflammatory biomarkers and metabolic risk factors in secondary prevention for cardiovascular disease, a randomised trial.
Bersch-Ferreira, AC, Hall, WL, Santos, RHN, Torreglosa, CR, Sampaio, G, Tereza da Silva, J, Alves, R, Ross, MB, Gehringer, MO, Kovacs, C, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(6):3828-3835
Abstract
BACKGROUND & AIMS To evaluate the effect of the Brazilian Cardioprotective Diet Program (BALANCE Program) on inflammatory biomarkers, involved in the pathophysiology of the atherosclerosis, on inflammatory biomarkers, cardiovascular risk factors, and on plasma fatty acids in cardiovascular disease secondary prevention patients. METHODS In this substudy of the BALANCE Program randomized clinical trial, a total of 369 patients aged 45 years or older, who have experienced cardiovascular disease in the previous 10 years, were included. These patients were randomized into two groups and followed up for six months: BALANCE Program group and control group (conventional nutrition advice). In the initial and six-month final visits, anthropometry (body weight, height and waist circumference), food intake evaluation by 24-h dietary recall, plasma inflammatory biomarkers (IL-6, IL-8, IL-10, IL-12, tumor necrosis factor-α, adiponectin, and C-reactive protein levels), blood pressure, glycemia, insulinemia, lipid profile, and plasma fatty acids levels were evaluated. RESULTS The BALANCE Program group showed increased plasma alpha-linolenic acid levels (P = 0.008), reduction in waist circumference (P = 0.049) and BMI (P = 0.032). No difference was observed among plasma inflammatory biomarkers and clinical data. CONCLUSION After six months of follow-up, BALANCE Program led to a significant reduction on BMI and waist circumference in individuals in secondary prevention for cardiovascular disease. Although plasmatic alpha-linolenic acid has increased, there was no impact on plasma inflammatory biomarkers. CLINICAL TRIAL REGISTRATION NCT01620398.
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Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial.
Marcadenti, A, Weber, B, Bersch-Ferreira, AC, Machado, RHV, Torreglosa, CR, de Sousa Lara, EM, da Silva, LR, Santos, RHN, Miyada, DHK, Sady, ERR, et al
Trials. 2021;(1):582
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 (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.
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[Quality of diet and daily spending on food by adults with cardiovascular disease in Brazil].
Torreglosa, CR, Sarti, FM, Bersch-Ferreira, ÂC, Weber, B, Santos, RHN, Chiavegatto Filho, ADP
Cadernos de saude publica. 2020;(10):e00225019
Abstract
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.
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Implementation of a Brazilian Cardioprotective Nutritional (BALANCE) Program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicenter trial.
Weber, B, Bersch-Ferreira, ÂC, Torreglosa, CR, Marcadenti, A, Lara, ES, da Silva, JT, Costa, RP, Santos, RHN, Berwanger, O, Bosquetti, R, et al
American heart journal. 2019;:187-197
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Abstract
BACKGROUND Appropriate dietary recommendations represent a key part of secondary prevention in cardiovascular disease (CVD). We evaluated the effectiveness of the implementation of a nutritional program on quality of diet, cardiovascular events, and death in patients with established CVD. METHODS In this open-label, multicenter trial conducted in 35 sites in Brazil, we randomly assigned (1:1) patients aged 45 years or older to receive either the BALANCE Program (experimental group) or conventional nutrition advice (control group). The BALANCE Program included a unique nutritional education strategy to implement recommendations from guidelines, adapted to the use of affordable and regional foods. Adherence to diet was evaluated by the modified Alternative Healthy Eating Index. The primary end point was a composite of all-cause mortality, cardiovascular death, cardiac arrest, myocardial infarction, stroke, myocardial revascularization, amputation, or hospitalization for unstable angina. Secondary end points included biochemical and anthropometric data, and blood pressure levels. RESULTS From March 5, 2013, to Abril 7, 2015, a total of 2534 eligible patients were randomly assigned to either the BALANCE Program group (n = 1,266) or the control group (n = 1,268) and were followed up for a median of 3.5 years. In total, 235 (9.3%) participants had been lost to follow-up. After 3 years of follow-up, mean modified Alternative Healthy Eating Index (scale 0-70) was only slightly higher in the BALANCE group versus the control group (26.2 ± 8.4 vs 24.7 ± 8.6, P < .01), mainly due to a 0.5-serving/d greater intake of fruits and of vegetables in the BALANCE group. Primary end point events occurred in 236 participants (18.8%) in the BALANCE group and in 207 participants (16.4%) in the control group (hazard ratio, 1.15; 95% CI 0.95-1.38; P = .15). Secondary end points did not differ between groups after follow-up. CONCLUSIONS The BALANCE Program only slightly improved adherence to a healthy diet in patients with established CVD and had no significant effect on the incidence of cardiovascular events or death.
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Triglyceride-glucose index is associated with symptomatic coronary artery disease in patients in secondary care.
da Silva, A, Caldas, APS, Hermsdorff, HHM, Bersch-Ferreira, ÂC, Torreglosa, CR, Weber, B, Bressan, J
Cardiovascular diabetology. 2019;(1):89
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.
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Effects of oral supplementation with probiotics or synbiotics in overweight and obese adults: a systematic review and meta-analyses of randomized trials.
Suzumura, EA, Bersch-Ferreira, ÂC, Torreglosa, CR, da Silva, JT, Coqueiro, AY, Kuntz, MGF, Chrispim, PP, Weber, B, Cavalcanti, AB
Nutrition reviews. 2019;(6):430-450
Abstract
CONTEXT Recent evidence suggests that modulation of the gut microbiota may contribute to body weight control. OBJECTIVE This systematic review aimed to assess the effects of oral supplementation with probiotics or synbiotics on body weight, body mass index (BMI), and waist circumference in overweight and obese adults (BMI ≥ 25 kg/m2). DATA SOURCES Five electronic databases-PubMed, Embase, Cochrane Library/CENTRAL, LILACS, and Web of Science-were searched from inception to August 2017. No language restrictions were applied. STUDY SELECTION Randomized and quasi-randomized parallel trials that assessed the effects of oral supplementation with probiotics or synbiotics vs any other intervention but bariatric surgery or fecal transplantation in overweight or obese adults were selected. DATA EXTRACTION Three teams of 2 authors independently assessed 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 GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. RESULTS Nineteen randomized trials (28 publications, 1412 participants) were included. There were no differences in mean body weight change [mean difference (MD), -0.54 kg; 95%CI, -1.09 to 0.01; I2 = 0%; moderate quality of evidence) or mean BMI change (MD, -0.19 kg/m2; 95%CI, -0.43 to 0.04; I2 = 51%; low quality of evidence) between groups who received probiotics or synbiotics and control groups. Oral supplementation with probiotics or synbiotics reduced mean waist circumference compared with control (MD, -0.82 cm; 95%CI, -1.43 to -0.21; I2 = 46%; low quality of evidence). CONCLUSIONS The findings suggest that oral supplementation with probiotics or synbiotics has a small effect to reduce waist circumference but no effect on body weight or BMI, although the quality of evidence is low to moderate. Therefore, the current evidence is not definitive. Large-scale trials are needed and may help to better inform clinical practice. SYSTEMATIC REVIEW REGISTRATION PROSPERO registration number CRD42018075126.
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Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension).
Schiavon, CA, Bersch-Ferreira, AC, Santucci, EV, Oliveira, JD, Torreglosa, CR, Bueno, PT, Frayha, JC, Santos, RN, Damiani, LP, Noujaim, PM, et al
Circulation. 2018;(11):1132-1142
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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.
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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.
Bersch-Ferreira, ÂC, Sampaio, GR, Gehringer, MO, Torres, EAFDS, Ross-Fernandes, MB, da Silva, JT, Torreglosa, CR, Kovacs, C, Alves, R, Magnoni, CD, et al
Nutrition journal. 2018;17(1):26
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It is known that people with cardiovascular disease (CVD) have increased inflammation and raised levels of circulating inflammatory molecules. The presence of insulin resistance is thought to increase these levels, as are certain fatty acids coming from dietary fats. The aims of this cross-sectional study were to compare the levels of inflammatory biomarkers in patients with CVD with and without insulin resistance, and to evaluate the possible link between the blood levels of fatty acids and inflammatory biomarkers among these patients. The authors concluded that the CVD patients with insulin resistance had a higher concentration of some inflammatory molecules in the blood than those without insulin resistance. They also observed that saturated fatty acids were linked to higher levels of inflammatory molecules in the blood, while unsaturated fatty acids correlated with lower levels.
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 < 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.
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Development of a dietary index based on the Brazilian Cardioprotective Nutritional Program (BALANCE).
Tereza da Silva, J, Bersch-Ferreira, ÂC, Torreglosa, CR, Weber, B, Levy, RB
Nutrition journal. 2018;(1):49
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 < 0,05). 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.
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The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).
Weber, B, Bersch-Ferreira, ÂC, Torreglosa, CR, Ross-Fernandes, MB, da Silva, JT, Galante, AP, Lara, Ede S, Costa, RP, Soares, RM, Cavalcanti, AB, et al
American heart journal. 2016;(1):73-81.e1-2
Abstract
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.