ABSTRACT
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.
Subject(s)
Hyperlipoproteinemia Type IIABSTRACT
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.
Subject(s)
Diet , Myocardial Infarction , Adult , Biomarkers , Blood Glucose , Cholesterol, LDL , Humans , Multicenter Studies as Topic , Myocardial Infarction/diagnosis , Myocardial Infarction/prevention & control , Randomized Controlled Trials as TopicABSTRACT
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.
Subject(s)
Cardiovascular Diseases/prevention & control , Diet/methods , National Health Programs/standards , Nutrition Assessment , Secondary Prevention/methods , Brazil/epidemiology , Cardiovascular Diseases/epidemiology , Feeding Behavior , Humans , Incidence , Survival Rate/trendsABSTRACT
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.
Subject(s)
Female , Humans , Male , Middle Aged , Atherosclerosis/diet therapy , Body Mass Index , Blood Glucose/metabolism , Blood Pressure/physiology , Cardiovascular Diseases/prevention & control , Diet/standards , National Health Programs/standards , Analysis of Variance , Atherosclerosis/metabolism , Brazil , Cultural Characteristics , Diet/methods , Feeding Behavior , Pilot Projects , Risk FactorsABSTRACT
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.
Subject(s)
Atherosclerosis/diet therapy , Blood Glucose/metabolism , Blood Pressure/physiology , Body Mass Index , Cardiovascular Diseases/prevention & control , Diet/standards , National Health Programs/standards , Analysis of Variance , Atherosclerosis/metabolism , Brazil , Cultural Characteristics , Diet/methods , Feeding Behavior , Female , Humans , Male , Middle Aged , Pilot Projects , Risk FactorsABSTRACT
Dietas ricas em calorias, sódio, gorduras saturadas e trans, a inatividade física e o tabagismo contribuem para o desenvolvimento e o progresso da aterosclerose. Atualmente, há evidências de que modificações do estilo de vida podem retardar o desenvolvimento da doença coronariana e a manifestação da aterosclerose. A terapia nutricional e a prática regular de exercícios são as primeiras condutas a serem recomendadas, por meio de ações clássicas de medicina preventiva aliada à atuação multiprofissional da equipe de saúde que cuida de pacientes em todos os âmbitos: hospitalar, saúde pública e serviços ambulatoriais e privados. Para alcançar esse objetivo, os pacientes devem ser informados sobre a importância da adesão à dieta e a um programa de exercícios, como conduta fundamental na mudança de estilo de vida. Na primeira parte desse artigo serão abordados os benefícios do treinamento físico aeróbico nas dislipidemias e na doença arterial coronariana, considerando inclusive seus possíveis mecanismos de ação, e a orientação de exercício físico para o paciente com doença arterial coronariana. E na segunda parte será abordada a influência da terapia nutricional nos fatores de risco para a doença arterial coronariana.
Subject(s)
Humans , Exercise/physiology , Nutrition Therapy/methods , Quality of Life , Risk FactorsABSTRACT
A insuficiência cardíaca (IC) apresenta prevalência crescente em todo o mundo, incluindo o Brasil, em decorrência, entre outros fatores, do envelhecimento da população. A industrialização e a urbanização implicaram mudanças na dieta, aumento do tabagismo, sedentarismo e obesidade e como conseqüência o desenvolvimento da hipertensão arterial, diabetes e doença coronariana, sendo a insuficiência cardíaca a via final dessas e de outras doenças.Até os anos 70 os conhecimentos sobre a fisiopatologia da insuficiência cardíaca se restringiam às manifestações dos distúrbios hemodinâmicos, ocasionando diminuição do débito cardíaco, baixo fluxo renal, levando à retenção de sódio e água e o aparecimento de edemas periféricos e pulmonares. A IC é freqüentemente acompanhada por retenção líquida, em que os diuréticos desempenham efeito favorável na melhora dos sintomas congestivos, aumentando a natriurese e a diurese.Os diuréticos utilizados no tratamento da IC pertencem a três grupos: tiazídicos, de alça e poupadores de potássio. Entretanto o uso crônico ou prolongado pode acarretar deficiência de tiamina, vitamina hidrossolúvel do complexo B, essencial para a conversão dos carboidratos e funcionamento do sistema nervoso, dos músculos e do coração.Uma das conseqüências da deficiência da tiamina é a vasodilatação periférica, com aumento dos shunts arteriovenosos e alteração da circulação em pequenos vasos. Além da maior excreção urinária de tiamina induzida pelo uso crônico dos diuréticos há também que se levar em conta que a idade dos pacientes e a desnutrição dos mesmos também são importantes fatores a serem considerados.
Subject(s)
Humans , Diuretics , Heart Failure , Thiamine DeficiencySubject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Coronary Artery Disease/prevention & control , Hyperlipidemias/therapy , Lipid Metabolism/physiology , Age Distribution , Hypolipidemic Agents/therapeutic use , Cholesterol/blood , Clofibric Acid/therapeutic use , Coronary Artery Disease/etiology , Coronary Artery Disease/physiopathology , Diet , Hyperlipidemias/complications , Hyperlipidemias/physiopathology , Lipid Metabolism/drug effects , Metabolic Syndrome/complications , Naphthalenes/therapeutic use , Risk Factors , Sex Distribution , Smoking/adverse effects , Triglycerides/bloodABSTRACT
O azeite de oliva é um dos principais ingridientes da Dieta do Mediterâneo, que apresenta relação inversa com a doença aterosclerótica. O efeito cardioprotetor dessa dieta tem sido atribuído em grande parte, à formulação exclusiva do azeite de oliva virgem. O alto teor de ácidos graxos monoinsaturados e de compostos fenólicos, especialemnte oleuropeína e o hidroxitirosol, está relacionado a ações antiaterogênicas, como redução da colesterolemia, redução da agregação plaquetária e diminuição da expressão de moléculas de adesão. Não existe grande variação no teor de ácidos graxos monoinsaturados no que se refere à qualidade de azeite, contudo a maior concentração de compostos fenólicos está no azeite extravirgem, obtido a partir de todo o fruto por meio da primeira prensa física a frio.
Subject(s)
Humans , Male , Adult , Diet, Mediterranean/adverse effects , Cardiovascular Diseases/complications , Cardiovascular Diseases/diagnosis , Fatty Acids, Monounsaturated/adverse effects , Fatty Acids, Monounsaturated , Antioxidants/classificationABSTRACT
Desnutrição e perda de peso podem modificar desfavoravelmente a evolução pós-operatória (PO) de crianças portadoras de cardiopatias congênitas submetidas a cirurgia cardiovascular (CCV). Nosso objetivo foi estudar a influência da modificação ponderal e o tempo de internação em 19 crianças de zero a dois meses, portadoras de cardiopatias congênitas, submetidas a CCV, na mortalidade PO. Elas receberam terapia nutricional enteral modular (150Kcal/Kg/dia) no PO até a alta da unidade de terapia intensiva e foram divididas em dois grupos: óbito (O) e sobrevida (S). Ocorreu desnutrição pré-operatória em 50%. O grupo O permaneceu mais tempo que o grupo S no hospital. O grupo S teve ganho ou manutenção do peso, enquanto o grupo O perdeu peso. Observou-se correlação positiva entre o tempo de internação e a perda de peso no grupo O (0,7291) e negativa para o grupo S (- 0,7405). A perda de peso correlacionou-se com o maior tempo de internação no grupo O e a manutenção ou ganho de peso correlacionada com a sobrevida no período PO de CCV por cardiopatias congênitas.
Malnutrition and weight loss may adversely modify the postoperative (PO) of children with congenital heart disease undergoing cardiac surgery (CCV). We studied the influence of changes in body weight and length of hospitalization in 19 children aged zero to two months, with congenital heart disease who underwent SVC, PO mortality. They received enteral feeding modular (150Kcal/Kg/dia) in the PO until discharge from the intensive care unit and were divided into two groups: death (O) and survival (S). Preoperative malnutrition occurred in 50%. The group stayed longer than the S group at the hospital. The S group had gain or weight maintenance, while the group lost weight. We observed a positive correlation between length of stay and the weight loss in group O (0.7291) and negative for the group S (- 0.7405). Weight loss correlated with longer hospital stay in group O and the maintenance or weight gain correlated with survival in the PO to LCC for congenital heart disease.
La malnutrición y la pérdida de peso puede modificar negativamente el postoperatorio (PO) de los niños con cardiopatías congénitas sometidos a cirugía cardiaca (CCV). Se estudió la influencia de los cambios en el peso corporal y la duración de la hospitalización en 19 niños de cero a dos meses, con una cardiopatía congénita que se sometieron a SVC, la mortalidad PO. Ellos recibieron alimentación enteral modular (150Kcal/Kg/dia) en el pedido hasta el alta de la unidad de cuidados intensivos y se dividieron en dos grupos: la muerte (O) y supervivencia (S). Malnutrición preoperatoria en 50%. El grupo se quedó más tiempo que el grupo S en el hospital. El grupo S presentó ganancia o el mantenimiento del peso, mientras que el grupo pierde peso. Se observó una correlación positiva entre la longitud de la estancia y la pérdida de peso en el grupo O (0.7291) y negativo para el grupo S (- 0.7405). La pérdida de peso se correlacionó con una mayor estancia hospitalaria en el grupo O y la ganancia o mantenimiento de peso se correlacionó con la supervivencia en el pedido a LCC para la enfermedad cardíaca congénita.
Subject(s)
Humans , Male , Female , Infant , Body Weights and Measures , Enteral Nutrition , Cardiac Surgical Procedures/mortality , Cardiac Surgical ProceduresABSTRACT
Desde o Egito antigo a dietoterapia adquire especial importância no tratamento do diabete melito. A evoluçäo dos cuidos dieterápicos aliou-se ao avanço científico dos tratamentos medicamentosos e do conhecimento fisiopatológico da doença. O sucesso da dietoterapia como tratamento único ou coadjuvante no diabete melito depende da realidade patológica, social e econômica dos pacientes. No presente estudo säo discutidos aspectos dietéticos, em terapia nutricional oral e enteral, que auxiliam o controle de pacientes portadores de diabete melito.
