An adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in familial hypercholesterolemia: A pilot study protocol

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

Pre-exercise meal on oxidation of energy substrates during maximal exercise test in non-trained individuals

ABSTRACT Objective: This study aimed to compare the influence of a high carbohydrate meal versus high-fat meal on the oxidation of substrates during an exercise incremental test. Materials and methods: Ten untrained male subjects underwent two days of the protocol. Randomly, they received a high carbohydrate meal or a high-fat meal, receiving the other one in the next protocol. On both days, they performed an incremental treadmill test, with heart rate and maximal oxygen consumption to estimate the oxidation of substrates. Results: The high-fat meal showed an increase in the absolute amount of oxidized fat along with the incremental test (P < 0.05; effect size = 0.9528), and a reduction in the respiratory exchange ratio at low intensities (P < 0.05; effect size = 0.7765). Conclusions: The meals presented no difference when compared to maximum oxidation point of substrates, the oxidation rate of substrates over time, and heart rate. A pre-test high-fat meal in untrained individuals was shown to be a modulating factor of total oxidized fats throughout the exercise, although it did not exert a significant effect on the rate of this oxidation over time.

Efeito da Dieta Cardioprotetora Brasileira suplementada ou não com amendoins (Arachis hypogaea) sobre parâmetros cardiometabólicos no pós-infarto agudo do miocárdio / Effect of the Brazilian Cardioprotective Diet supplemented or not with peanuts on cardiometabolic parameters after acute myocardial infarction

Introdução: as doenças cardiovasculares (DCV) são responsáveis por quase 18 milhões de óbitos ao ano no mundo, sendo que o infarto agudo do miocárdio (IAM) acomete aproximadamente 300.000 brasileiros anualmente. A Dieta Cardioprotetora Brasileira (DICA-BR) foi projetada para facilitar a orientação nutricional à população brasileira, tendo por base as diretrizes clínicas nacionais, e como pano de fundo a dieta mediterrânea e as diretrizes da American Heart Association. O amendoim possui componentes como fibras, proteínas, arginina, compostos fenólicos, niacina, folato, magnésio, manganês e ácidos graxos mono e poli-insaturados, cuja composição nutricional apresenta potencial de modulação do risco cardiovascular. Objetivo: avaliar o efeito da DICA-BR, suplementada ou não com amendoim, sobre parâmetros cardiometabólicos em pacientes com IAM recente. Métodos: estudo caracterizado como um ensaio clínico randomizado, com um total de 100 indivíduos, alocados em dois grupos (taxa de alocação 1:1). Os critérios de inclusão são idade superior a 40 anos e ter episódio de IAM entre os últimos 60 e 180 dias. O grupo 1 recebeu orientação alinhada à DICA-BR enquanto o grupo 2 recebeu a orientação alinhada à DICA-BR e suplementação de 30 g/dia de amendoim. Os pacientes foram acompanhados por quatro meses, com as visitas ocorrendo aos 30, 60, 90 e 120 dias após o início do protocolo experimental. Ao longo do estudo, foram realizadas a avaliação antropométrica, recordatórios 24 horas, avaliação de medicação utilizada e dos hábitos de exercício físico e tabagistas, questionário socioeconômico e coleta de sangue para exames bioquímicos. O desfecho primário do estudo em tela foi a concentração plasmática de colesterol associado à lipoproteína de baixa densidade (LDL-c), e os secundários foram caracterizados como demais indicadores de perfil lipídico e controle glicêmico, ingestão alimentar, índices antropométricos, concentração de malondialdeído (MDA) e de antioxidantes totais (TAOC), atividade da enzima catalase e perfil de ácidos graxos na membrana plasmática de eritrócitos. Para as análises estatísticas foram efetuados testes t pareado. Resultados: não foi verificada diferença significativa referente à variação da concentração plasmática de LDL-c nos grupos 1 e 2 ao longo do protocolo. Foi constatada redução significativa da concentração plasmática de triacilgliceróis em indivíduos do grupo 1 (191 mg/dL [t=0] vs 160 mg/dL [t=1]; p = 0,03), bem como foi verificado aumento significativo da concentração plasmática de HDL-c no grupo 2 (40,3 mg/dL [t=0] vs 42,8 mg/dL [t=1]; p = 0,003). O grupo 2 apresentou redução no consumo energético total (1772 kcal/dia [t=0] vs 1374 kcal/dia [t=1]; p = 0,002) e ambos os grupos apresentaram diminuição das concentrações de MDA (Grupo 1: 0,63 µMol/mL [t=0] vs 0,4 µMol/mL [t=1]; p = 0,007 e grupo 2: 0,81 µMol/mL vs 0,4 µMol/mL; p = 0,038). Os demais biomarcadores não apresentaram diferença significativa. Conclusão: após 16 semanas de acompanhamento, os resultados obtidos evidenciam que a DICA-BR, de forma isolada, promove melhora do risco cardiovascular por meio da redução de biomarcadores plasmáticos, como concentração de triacilgliceróis e a razão triacilglicerol/HDL e diminuição de índices antropométricos, como o IMC e a circunferência da cintura. Não obstante, a DICA-BR, quando suplementada com amendoins, apresenta impacto positivo sobre a concentração plasmática de HDL-c, o que sugere potencial benefício dessa intervenção em relação ao transporte reverso do colesterol.

Introduction: cardiovascular diseases (CVD) are responsible for almost 18 million deaths a year worldwide, and acute myocardial infarction (AMI) affects approximately 300,000 Brazilians annually. The Brazilian Cardioprotective Diet (DICA-BR) was designed to facilitate nutritional guidance to the Brazilian population based on national clinical guidelines and the backdrop of the Mediterranean diet and the American Heart Association guidelines. Peanut has components such as fiber, proteins, arginine, phenolic compounds, niacin, folate, magnesium, manganese, and monounsaturated and polyunsaturated fatty acids, whose nutritional composition has the potential to modulate cardiovascular risk. Objective: to evaluate the effect of DICA-BR, supplemented or not with peanuts, on cardiometabolic parameters in patients with recent AMI. Methods: the study was a randomized clinical trial, with 100 individuals allocated into two groups (allocation ratio 1:1). Inclusion criteria are age over 40 years and having an AMI episode between the last 60 and 180 days. Group 1 received DICA-BR-aligned guidance while group 2 received DICA-BR-aligned guidance and peanut supplementation of 30 g/day. Patients were followed for four months, with visits occurring at 30, 60, 90, and 120 days after the start of the experimental protocol. Throughout the study, anthropometric assessment, 24-hour recalls, assessment of medication used and physical exercise and smoking habits, socioeconomic questionnaire, and blood collection for biochemical tests were performed. The primary outcome of the present study was the plasma concentration of cholesterol associated with low-density lipoprotein (LDL-c), and the secondary outcomes were characterized as other indicators of lipid profile and glycemic control, food intake, anthropometric indices, malondialdehyde concentration (MDA), and total antioxidants (TAOC), catalase enzyme activity and fatty acid profile in the plasma membrane of erythrocytes. For statistical analysis, paired t-tests were performed. Results: there was no significant difference regarding the variation of plasma LDL-c concentration in groups 1 and 2 throughout the protocol. A significant reduction in the plasma concentration of triacylglycerols was observed in individuals in group 1 (191 mg/dL [t=0] vs 160 mg/dL [t=1]; p = 0.03), as well as a significant increase in the concentration plasma HDL-c in group 2 (40.3 mg/dL [t=0] vs 42.8 mg/dL [t=1]; p = 0.003). Group 2 showed a reduction in total energy consumption (1772 Kcal/day [t=0] vs 1374 Kcal/day [t=1]; p = 0.002) and both groups showed a decrease in MDA concentrations (Group 1: 0, 63 µMol/mL [t=0] vs 0.4 µMol/mL [t=1]; p = 0.007 and group 2: 0.81 µMol/mL vs 0.4 µMol/mL; p = 0.038). The other biomarkers showed no significant difference. Conclusion: after 16 weeks of follow-up, the results show that in isolation, DICA-BR promotes an improvement in cardiovascular risk by reducing plasma biomarkers, such as triacylglycerol concentration and the triacylglycerol/HDL ratio, and reduction in anthropometric indices, such as BMI and waist circumference. However, when supplemented with peanuts, DICA-BR has a positive impact on plasma HDL-c concentration, suggesting a potential benefit of this intervention concerning reverse cholesterol transport.