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Background & Aims: Diet is a modifiable risk factor, which may influence the gene expression and the concentration of inflammatory biomarkers related to obesity and atherosclerosis. In this substudy from Brazilian Cardioprotective Nutritional (BALANCE) Program, we hypothesized that a nutritional intervention based on the usual Brazilian diet modulates the expression of genes involved with atherosclerosis and inflammatory biomarkers in male patients, in the secondary prevention for cardiovascular disease., Methods: Six male patients, aged 45 years or older, obese, were selected to follow a qualitative-quantitative food plan for 6 months. Glycemia, insulinemia, lipid profile, plasma concentration of inflammatory biomarkers (interleukin (IL) -1β), IL-6, IL-8, IL-10, IL-12, tumor necrosis factor alpha, C-reactive protein and adiponectin, and expression of 84 atherosclerosis-related genes in total peripheral blood cells, were measured., Results: After nutritional intervention, the participants reduced weight (p < 0.04), waist circumference (p < 0.04), Homeostasis Model Assessment index for insulin resistance (p = 0.046) and overall leukocyte count (p = 0.046) and neutrophils (p = 0.028). There was no significant modification in the plasma concentration of the inflammatory biomarkers, however, there was a significant increase in the expression of Apo A1 (p = 0.011), ELN (p = 0.017) and IL4 (p = 0.037) genes., Conclusions: The BALANCE Program, the qualitative-quantitative food plan composed of Brazilian usual foods, did not reduce the concentration of inflammatory biomarkers, but increased in total peripheral blood cells the expression of genes involved in reducing the risk of cardiometabolic in obese patients, in secondary prevention for cardiovascular disease. The clinical trial is registered at https://clinicaltrials.gov/ and the unique identifier is NCT01620398., Competing Interests: Declaration of competing interest All the authors declare that they have no conflict of interest., (Copyright © 2020 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

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.

Objective: The aim of this study was to assess the association between polyunsaturated fatty acids (PUFAs) and inflammatory biomarkers among patients in secondary prevention of cardiovascular disease (CVD)., Methods: In this cross-sectional substudy from BALANCE Program Trial, we have collected data from 364 patients with established CVD. Twenty-four-hour dietary recalls and plasma FA concentrations were analyzed to estimate the FA intake. Inflammatory biomarkers measurement consisted of interleukin (IL)-1β, IL-6, IL-8, IL-10, IL-12, C-reactive protein, adiponectin, and tumor necrosis factor-α. After log-transformation of inflammatory biomarkers, multivariate-adjusted general linear model was used to examine the effect of FA intake. The association was adjusted for body mass index, waist circumference, energy, smoking status, age, total cholesterol, low-density lipoprotein cholesterol, physical activity, and calcium channel blockers., Results: PUFAs were inversely associated with C-reactive protein levels (P = 0.006) and with IL-1 β. The increase of 1 g/1000 kcal in PUFAs, omega-3, and omega-6 reduces, on average, 6%, 48%, and 8% respectively, the mean concentration of IL-1 β., Conclusion: Omega-3 and omega-6 FA intakes are inversely associated with inflammatory biomarkers among CVD patients. Additional studies on omega-3 and omega-6 intake in relation to inflammatory biomarkers in patients in secondary prevention of CVD are needed, particularly regarding dietary patterns that are rich in some sources of PUFA., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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.