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.

Factors associated with diet quality among Brazilian individuals with cardiovascular diseases

BACKGROUND: An individual's dietary pattern contributes in different ways to the prevention and control of recurrent cardiovascular events. However, the quality of the diet is influenced by several factors. The present study aimed to evaluate the quality of the diet of individuals with cardiovascular diseases and determine whether there is an association between sociodemographic and lifestyle factors. METHODS: This is a cross-sectional study carried out with individuals with atherosclerosis (coronary artery disease, cerebrovascular disease or peripheral arterial disease) recruited from 35 reference centres for the treatment of cardiovascular disease in Brazil. Diet quality was assessed according to the Modified Alternative Healthy Eating Index (mAHEI) and stratified into tertiles. For comparing two groups, the Mann-Whitney or Pearson's chi-squared tests were used. However, for comparing three or more groups, analysis of variance or Kruskal-Wallis was used. For the confounding analysis, a multinomial regression model was used. p < 0.05 was considered statistically significant. RESULTS: In total, 2360 individuals were evaluated: 58.5% male and 64.2% elderly. The median (interquartile range [IQR]) of the mAHEI was 24.0 (20.0-30.0), ranging from 0.4 to 56.0 points. When comparing the odds ratios (ORs) for the low (first tertile) and medium (second tertile) diet quality groups with the high-quality group (third tertile), it was observed that there was an association between diet quality with a family income of 1.885 (95% confidence intervals [CI] = 1.302-2.729) and 1.566 (95% CI = 1.097-2.235), as well as physical activity of 1.391 (95% CI = 1.107-1.749) and 1.346 (95% CI = 1.086-1.667), respectively. In addition, associations were observed between diet quality and region of residence. CONCLUSIONS: A low-quality diet was associated with family income, sedentarism and geographical area. These data are extremely relevant to assist in coping with cardiovascular disease because they enable an assessment of the distribution of these factors in different regions of the country.

Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial.

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.

Inadequação calórico-proteica e associação com Indicadores de Qualidade em Terapia Nutricional na assistência ao paciente crítico / Caloric-protein inadequacy and its association with Indicators of Nutritional Therapy Quality in critical patient assistance

A Terapia Nutricional (TN) é um conjunto de intervenções terapêuticas, essenciais na assistência ao paciente crítico.No ambiente de Terapia Intensiva, diversos fatores inviabilizam a execução eficaz da TN. Na perspectiva de garantira gestão da qualidade em TN, foram criados os Indicadores de Qualidade em Terapia Nutricional (IQTN). O objetivo do estudo foi avaliar a adequação calórico-proteica da terapia nutricional enteral TNE administrada; identificar as taxas de conformidade ou não conformidade em relação à frequência de pacientes em jejum por mais de 24 horas em TNE,a frequência de saída inadvertida de sonda nas o enteral SNE em pacientes com TNE e a frequência de obstruções deSNE em pacientes em TNE, e ainda a associação entre os IQTN avaliados e a adequação calórico-proteica...

The Nutritional Therapy (TN) is a set of essential therapeutic interventions for the care of critically ill patients. In theintensive care environment, several factors make the effective implementation of TN impossible. With a view to ensurethe quality of management in TN, the Nutritional Therapy Quality Indicators (IQTN) were created. The aim of thestudy was to evaluate caloric-protein adequacy of Enteral Nutritional Therapy (TNE) administered, and to identify thecompliance or non-compliance rates in relation to the three IQTNs: frequency of fasting patients for more than 24 hoursin TNE, frequency of inadvertent enteral tube feeding exit in patients with TNE, and frequency of enteral tube feedingobstructions in TNE patients. In addition, the association between the IQTN evaluated and caloric-protein adequacy wasverified.

Avaliação nutricional de pacientes onco-hematológicos em quimioterapia suplementados com glutamina / Nutritional assessment of glutamine-supplemented onco-hematological patients submitted to chemotherapy

Objetivos: Avaliar o impacto da suplementação oral de glutamina sobre o estado nutricional de pacientes com neoplasia hematológicaem quimioterapia e comparar os efeitos obtidos com doses de 0,3g/Kg/dia e 0,65g/Kg/dia. Materiais e métodos: Trata-se de ensaio clínico,randomizado, cego. Foram acompanhados 17 pacientes, dividido sem grupo 1 com oito indivíduos e grupo 2 com nove indivíduos que receberam, respectivamente, 0,3 g/Kg/dia e 0,65g/Kg/dia do suplemento. Para avaliação nutricional utilizou-se circunferênciabraquial, prega cutânea triciptal, circunferência muscular do braço,índice de massa corporal e Avaliação Subjetiva Global Produzida Pelo Paciente. Também foram analisados parâmetros bioquímicos, como hemoglobina, hematócrito, leucócitos, neutrófilos, proteínas totais,albumina e proteína C reativa. Essas variáveis foram avaliadas emdois momentos, antes da intervenção e após 30 dias de uso daglutamina. Resultados: Houve manutenção ou aumento da maioria dos parâmetros antropométricos e de acordo com a Avaliação Subjetiva Global Produzida Pelo Paciente verificou-se alteração da classificação de desnutrição moderada para bem nutrido em 50% no grupo 1 e11,1% no grupo 2, sem significado estatístico intragrupo e entre grupos. Os parâmetros bioquímicos não diferiram em efeito com as doses utilizadas. Conclusão: A suplementação de glutamina nas quantidades de 0,3g/Kg/dia e 0,65g/Kg/dia não propiciaram diferenças significativas na melhora do estado nutricional, porém sugere-se queseu uso possa auxiliar na manutenção da condição nutricional inicial dos pacientes com leucemias agudas e linfomas em quimioterapia.

Objectives: To assess the impact of oral glutamine supplementation on the nutritional status of patients with hematologic malignancy submitted to chemotherapy, and to compare the effects obtained withdoses of 0.3 g/kg/day and 0.65 g/kg/day. Materials and Methods:This was an experimental, randomized, blinded study. A total of 17patients were divided into two groups: group 1, administered 0.3 g/kg/day (n=8), and group 2, administered 0.65 g/kg/day (n=9). For nutritional assessment, we evaluated arm circumference, triceps skin foldthickness, arm muscle circumference, body mass index and the Subjective Global Assessment Produced by the Patient. Biochemicalparameters, such as hemoglobin, hematocrit, leukocytes, total protein,albumin, and C-reactive protein, were also analyzed. These variableswere evaluated in two stages, before intervention and after 30 daysof glutamine use. Results: Most anthropometric parameters weremaintained or increased after supplementation. According to theSubjective Global Assessment Produced by the Patient, malnutrition rating changed from moderate to well-nourished by 50% in group 1and 11.1% in group 2, with no statistically significant differencebetween and intra-groups. The biochemical parameters did not differwith the doses used. Conclusion: Glutamine supplementation in the amounts of 0.3 g/kg/day and 0.65 g/kg/day did not promote significant differences in improvement of nutritional status. Nevertheless, itsuse can help maintain the initial nutritional status of patients withacute leukemia and lymphomas undergoing chemotherapy.

Suplementação de creatina na composição corporal de pacientes com insuficiência cardíaca / Creatine supplement effects on body composition among patients with heart failure

Fundamentos: A perda de massa muscular, independente da massa corpórea total, é comorbidade frequente entre os pacientes com insuficiência cardíaca, que pode resultar em piora dos sintomas clínicos, reduzida capacidade funcional e consequente progressão da doença. Objetivo: Avaliar a composição corporal dos pacientes com IC suplementados com creatina. Métodos: Estudo prospectivo, randomizado, duplo-cego, com 33 pacientes, sexo masculino, idade >18 anos, IC classes funcionais II a IV segundo classificação da New York Heart Association, atendidos em hospital de referência da região centro-oeste do Brasil. Os pacientes foram estratificados, aleatoriamente, em grupo experimental (CRE, n=17), suplementado com creatina mono-hidratada e grupo-placebo (PLA, n=16), que recebeu maltodextrina. A ingestão do suplemento ou do placebo correspondia a 5 g diárias durante seis meses. Os pacientes foram submetidos à avaliação antropométrica e de consumo alimentar antes e após a suplementação. O modelo estatístico Ancova foi utilizado na análise dos grupos e nas formas de tratamento. Resultados: A massa corporal total, massa corporal magra e percentual de gordura não apresentaram diferença significativa entre os grupos. Quanto ao valor calórico energético total e macronutrientes da dieta, apenas as quantidades médias de lipídeos no grupo CRE apresentaram-se estatisticamente inferiores (p=0,0268). Conclusão: A suplementação alimentar de creatina não alterou a composição corporal de pacientes com IC.

Background: Regardless of total body mass, muscle mass loss is a frequent co-morbidity among patients with heart failure, which may worsen clinical symptoms, with reduced functional capacity and consequent progression of the disease. Objective: To evaluate the body composition of patients with HF supplemented with creatine. Methods: Prospective, randomized, double-blind study with 33 patients, male, age over 18 years, HF functional class II to IV as classified by the New York Heart Association, seen at a reference hospital in the Center-West Brazil. The patients were randomly divided into an experimental group (CRE, n=17), supplemented with creatine monohydrate and a placebo group (PLA, n=16), which received maltodextrin, taking 5 g of the supplement or placebo daily for six months. The patients underwent anthropometric and food consumption evaluations before and after taking the supplement. The Ancova statistical model was used to analyze the groups and forms of treatment. Results: Total body mass, lean body mass and body fat percentage showed no significant differences between the groups. With regard to calorie value, total energy and macronutrients in the diet, only the average amounts of lipids in the CRE group were statistically lower (p=0.0268).Conclusion: Adding a creatine supplement to their diet did not alter the body composition of patients with HF.

Influência da suplementação de creatina na capacidade funcional de pacientes com Insuficiência Cardíaca / Influence of creatine supplementation on the functional capacity of patients with Heart Failure

FUNDAMENTO: A Insuficiência Cardíaca (IC) é uma síndrome complexa, marcada pela intolerância ao esforço e perda da capacidade funcional. OBJETIVO: Avaliar a capacidade funcional dos pacientes com IC suplementados com creatina. MÉTODOS: Estudo prospectivo, randomizado, duplo cego. Foram randomizados em dois grupos 33 pacientes com IC, com idade > 18 anos, sexo masculino, classes funcionais II a IV. O grupo experimental (G CRE, n = 17) foi suplementado com creatina com dose de 5 g por dia durante seis meses. E o grupo placebo (G PLA, n = 16) recebeu 5 g de maltodextrina por dia durante o mesmo período de tempo. Ambos os grupos foram submetidos a avaliação da capacidade funcional por meio da ergoespirometria e teste de caminhada de seis minutos (TC6) pré e pós-intervenção. O modelo estatístico Ancova e a correlação de Pearson foram utilizados na análise dos grupos e nas formas de tratamento. RESULTADOS: Das variáveis avaliadas na ergoespirometria, o volume de oxigênio pico (VO2 pico), limiar anaeróbio (LA) e o pulso de oxigênio (pulso de O2) não apresentaram diferenças significativas entre os grupos (P>0,05). No TC6 não houve diferença significativa na distância percorrida. CONCLUSÃO: A suplementação de creatina em pacientes com IC não promoveu melhora significativa na capacidade funcional.

BACKGROUND: Heart failure (HF) is a complex syndrome characterized by intolerance to exertion and reduced functional capacity. OBJECTIVE: To assess the functional capacity of patients with HF and supplemented with creatine. METHODS: Prospective, randomized, double-blind study. Thirty-three male patients over the age of 18 years with functional class II to IV HF were randomized into two groups as follows: the experimental group (CRE, n = 17), supplemented with 5 g/day of creatine for six months; and the placebo group (PLA, n = 16), receiving 5 g/day of maltodextrin for that same period. Both groups underwent functional capacity assessment by use of cardiopulmonary exercise test and 6-minute walk test (6MWT) before and after the intervention. The Ancova statistical model and Pearson correlation were used to assess the groups and the treatment. RESULTS: Of the variables assessed on the cardiopulmonary exercise test, peak oxygen consumption (peak VO2), anaerobic threshold (AT), and oxygen pulse (O2 pulse) showed no significant differences between the groups (P>0.05). On the 6MWT, no significant difference was observed in the covered distance. CONCLUSION: Creatine supplementation in patients with HF did not significantly improve functional capacity.

Influence of creatine supplementation on the functional capacity of patients with heart failure.

BACKGROUND: Heart failure (HF) is a complex syndrome characterized by intolerance to exertion and reduced functional capacity. OBJECTIVE: To assess the functional capacity of patients with HF and supplemented with creatine. METHODS: Prospective, randomized, double-blind study. Thirty-three male patients over the age of 18 years with functional class II to IV HF were randomized into two groups as follows: the experimental group (CRE, n = 17), supplemented with 5 g/day of creatine for six months; and the placebo group (PLA, n = 16), receiving 5 g/day of maltodextrin for that same period. Both groups underwent functional capacity assessment by use of cardiopulmonary exercise test and 6-minute walk test (6MWT) before and after the intervention. The Ancova statistical model and Pearson correlation were used to assess the groups and the treatment. RESULTS: Of the variables assessed on the cardiopulmonary exercise test, peak oxygen consumption (peak VO2), anaerobic threshold (AT), and oxygen pulse (O2 pulse) showed no significant differences between the groups (P>0.05). On the 6MWT, no significant difference was observed in the covered distance. CONCLUSION: Creatine supplementation in patients with HF did not significantly improve functional capacity.

Suplementação com creatina associada ao treinamento resistido não altera as funções renal e hepática / Creatine supplementation associated with resistance training does not alter renal and hepatic functions

A creatina é o suplemento nutricional mais popular utilizado para melhorar o desempenho em atividades que envolvem exercícios de curta duração e alta intensidade. Porém, as possíveis intercorrências advindas do seu uso não estão totalmente elucidadas. O objetivo do estudo foi avaliar os efeitos de duas dosagens de suplementação com creatina nas funções renal e hepática de adultos saudáveis durante oito semanas de treinamento de musculação. Exames bioquímicos foram realizados em 35 praticantes de musculação distribuídos aleatoriamente em três grupos, placebo (PLA, n = 12), creatina (CRE1, n = 12) e creatina 2 (CRE2, n = 11), antes e após oito semanas de treinamento com exercícios resistidos. Em desenho duplo-cego, os voluntários foram suplementados (20g/dia) com creatina (CRE1 e CRE2) ou placebo (PLA) por sete dias e nos 53 dias subsequentes com 0,03g/kg de massa corporal de creatina (CRE1) e placebo (PLA) e com 5g/dia o grupo CRE2. Não houve intervenção na composição de suas dietas, que foram registradas e analisadas. Os resultados dos exames bioquímicos realizados permaneceram dentro das faixas de normalidade. Os valores de creatinina aumentaram 12,2 por cento no grupo CRE1 e 9,0 por cento, no CRE2, enquanto que no grupo PLA diminuiu 4,7 por cento, entretanto, esses valores não ultrapassaram os índices de normalidade. Os valores dos exames da função hepática diminuíram em quase todas as frações, em todos os tratamentos, contudo, sem significância estatística. Conclui-se que a suplementação com creatina nas dosagens utilizadas (0,03g/kg e 5g/dia) para indivíduos saudáveis por oito semanas não altera a função hepática ou renal, sendo assim, nas condições deste estudo, foi considerada segura.

Creatine is the most popular nutritional supplement widely used to improve performance in activities that involve exercise of short duration and high intensity. However, the complications arising from its use are not fully elucidated. The aim of this study was to evaluate the effects of two doses of creatine supplementation on renal and hepatic function in healthy adults during eight weeks of resistance exercise training. Biochemical tests were performed on 35 athletes randomly distributed into three groups, placebo (PLA, n = 12), creatine (CRE1, n = 12) and creatine2 (CRE2, n = 11) before and after eight weeks of resistance training. In a double-blind design, the volunteers were supplemented (20 g/day) with creatine (CRE1, CRE2) or placebo (PLA) for seven days and at the 53 subsequent days with 0.03g/kg of body weight of each supplement (CRE1, PLA) and 5g/day for CRE2. There was no intervention in the composition of their diets, which were recorded and analyzed. The results of biochemical tests conducted remained within normal ranges. Creatinine values increased by 12.2 percent for CRE1 and 9.0 percent for CRE2, whereas decreased by 4.7 percent in PLA; however, these values did not exceed normal rates. The values of liver function tests declined in nearly all fractions in all treatments, not being statistically significant, though. It is concluded that creatine supplementation at the dosages used (0.03g/kg and 5g/day) for healthy subjects during eight weeks does not alter hepatic or renal function, hence under the conditions of this study, creatine was considered safe.