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PURPOSE: Nut-enriched diets are related to improve lipid and inflammatory biomarkers in meta-analyses in the context of primary cardiovascular prevention. However, primary studies on secondary cardiovascular prevention are scarce and controversial. This systematic review and meta-analysis aimed to evaluate the effect of nut supplementation on lipid and inflammatory profiles in individuals with atherosclerotic cardiovascular disease, and the frequency of adverse events. METHODS: Six databases were used for research: PubMed, EMBASE, BVS, Cochrane Library, Web of Science, and ClinicalTrials.gov, until February 2023, with no language restrictions. We performed random-effects meta-analyses to compare nut-enriched diets vs. control diets for pre-post intervention changes. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system assessed the evidence's certainty. RESULTS: From the 5187 records identified, eight publications containing data referring to five randomized clinical trials involving 439 participants were included in the final analyses. The nuts evaluated were almonds, pecans, Brazil nuts, and mixed nuts, with doses ranging between 5 g and 85 g (median: 30 g/day). The intervention time varied between 6 and 12 weeks. Compared to nut-free diets, nut intake did not have a statistically significant effect on lipid profile biomarkers, except on the atherogenic index (MD: -0.32 [95% CI -0.58 to -0.06], I2 = 0% - moderate certainty of the evidence). Similarly, there was no effect of nuts on inflammatory profile biomarkers. It was not possible to aggregate data on adverse events. CONCLUSIONS: Nut supplementation did not change lipid and inflammatory profiles in the secondary cardiovascular prevention setting.

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CONTEXT: Nut-enriched diets have a positive impact on cardiovascular risk factors, such as body mass, blood pressure, and fasting blood glucose. However, studies in individuals undergoing secondary cardiovascular prevention show controversial results. OBJECTIVE: This systematic review with meta-analysis assessed the effect of nut supplementation on anthropometric, glycemic, and blood pressure indices in patients with atherosclerotic cardiovascular disease, as well as the frequency of adverse events. DATA SOURCES: Six databases were used for the search-PubMed, Cochrane Library, EMBASE, BVS (Biblioteca Virtual da Saude), Web of Science, and ClinicalTrials.gov-until February 2023, with no language restrictions. DATA EXTRACTION: The Cochrane Handbook for Systematic Reviews of Interventions methodology and the PICOS (Population, Intervention, Comparison, Outcome, Setting/design) strategy were used. Seven independent reviewers were involved in data extraction and resolution of disagreements. Certainty of the evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. DATA ANALYSIS: From 5187 records identified, 6 publications containing data referring to 5 randomized clinical trials (n = 436) were included in the final analyses. The nuts evaluated were almonds, pecans, Brazil nuts, and mixed nuts, with portions that varied between 5 g and 85 g (median: 30 g/day). The intervention period varied between 6 and 12 weeks. The nuts had no effect on fasting glucose and anthropometric indices, although the certainty of the evidence for most of these outcomes was low or very low. They also had no effect on systolic (mean difference [MD]: -1.16 mmHg [95% CI, -5.68 to 3.35], I2 = 0%-moderate certainty of evidence) or diastolic (MD: 0.10 mmHg [95% CI, -2.30 to 2.51], I2 = 0%-high certainty of evidence) blood pressure. It was not possible to aggregate data on adverse events. CONCLUSION: Nut supplementation had no effect on blood pressure, fasting glucose, or anthropometric profile in the context of atherosclerotic cardiovascular disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42020163456.

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BACKGROUND AND AIM: Increased consumption of ultra-processed foods has been linked to both mortality and cardiovascular risk. Copeptin levels may serve as potential risk markers for cardiovascular death and events. This cross-sectional analysis seeks to assess the potential correlation between the intake of ultra-processed foods and copeptin levels in outpatients diagnosed with type 2 diabetes, based on estimates of cardiovascular risk. METHODS AND RESULTS: Outpatients underwent clinical and nutritional assessments. Dietary information was gathered using a validated quantitative food frequency questionnaire, and the consumption of all foods, beverages, and food products was assessed according to the NOVA food classification system. Fasting plasma-EDTA samples were collected and preserved at -80 °C. Plasma copeptin measurements were analyzed using an enzyme-linked immunosorbent assay based on the competition principle. Participants were categorized into two groups: high risk and very high risk, based on cardiovascular risk calculated by the HEARTS calculator. A total of 190 participants were included in the evaluation, with an average age of 60 ± 9 years, glycated hemoglobin of 8.4 ± 1.4%, and a diabetes duration of 11 (5-19) years. Patients at a very high cardiovascular risk exhibited higher plasma copeptin levels compared to those at high cardiovascular risk. Notably, 92.1% of patients reported consuming more than 10% of total energy intake from ultra-processed foods, although this proportion did not differ between the two groups. CONCLUSION: This patient sample reported elevated consumption of ultra-processed foods; nevertheless, the correlation between ultra-processed foods and plasma copeptin has not been substantiated.

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OBJECTIVE: The objective was to evaluate the psychometric properties of the Mindful Eating Questionnaire (MEQ) in Brazilian subjects with type 2 diabetes mellitus (T2DM) and validate a Brazilian version of the MEQ for adults with T2DM (MEQ-DM). METHODOLOGY: Baseline data from the multicentre Nutritional Strategy for Glycaemic Control in Patients with Type 2 Diabetes Mellitus (NUGLIC) trial were used. Construct validity was assessed using exploratory factor analysis (EFA). The root mean square error of approximation (RMSEA), comparative fit index (CFI) and Tucker‒Lewis index (TLI) fit indices indicated the adequacy of the model. The reliability of the questionnaire was evaluated considering the different factor loadings. Criterion validity was tested by correlating the MEQ-DM with sociodemographic variables, body mass index (BMI) and physical activity levels. RESULTS: A total of 370 participants were included, who were mostly female (60.8 %) and had a median age of 61 (54-67) years. The EFA results supported the two-factor structure of the 25-item MEQ-DM: disinhibition and awareness. The results of the fit indices (RMSEA = 0.04; CFI = 0.95 and TLI = 0.94) and composite reliability (disinhibition = 0.84 and awareness = 0.81) were consistent. The criterion validity analysis indicated a significant association between MEQ-DM scores and age, sex, civil status, education level, BMI and physical activity (p < 0.05). CONCLUSION: When explored with Brazilian adults with T2DM, the MEQ-DM presented a factorial model with two dimensions: disinhibition and awareness. This model must be confirmed in future studies with Brazilians with T2DM.

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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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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-a, 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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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 ±â€¯8.4 vs 24.7 ±â€¯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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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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