Effect of the Brazilian Cardioprotective Diet and Nuts on Cardiometabolic Parameters in Post-acute Myocardial Infarction: a Randomized Clinical Trial (DICA-NUTS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 10
- 主要终点
- LDL-c
研究概览
简要总结
Coronary artery disease (CAD) is the leading cause of death worldwide. Dietary patterns and functional foods may play an important role in the management of cardiovascular risk factors such as overweight and dyslipidemia, as well as inflammation and oxidative stress. However, little is known regarding the effect of diets or specific nutrients on these parameters in individuals with acute myocardial infarction (AMI). The Brazilian Cardioprotective Diet (DicaBr) is based on Brazilian nutritional guidelines and also in a unique and ludic nutritional strategy. In a pilot study, this diet was effective in reducing blood pressure (intragroup comparison) and body weight (intergroup comparison) in individuals with established cardiovascular disease (CVD). However, the effectiveness of this dietary pattern supplemented with different kind of nuts is unknown. The aim of this study is to evaluate the effect of the DicaBr supplemented or not with 30g/day of different nuts on cardiometabolic parameters in patients with recent AMI. In this parallel randomized controlled trial, 388 patients ≥40 years with a recent diagnosis of AMI (60 to 180 days) will be allocated to one of two study groups: 1) DicaBr group (DCB, control group); or 2) DicaBr group supplemented with mixed nuts (DCBN, intervention group). All patients will receive the same dietary prescription, the DCBN group also will receive 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazilian nuts). A pilot study including 100 individuals who will receive only peanuts (30g/day) will be conducted. The primary outcome will be LDL-cholesterol (LDL-c) levels after 16 weeks. In the baseline and at the end of the study (16 weeks), lipid and glycemic profile and anthropometric indexes will be evaluated in both groups; inflammatory and oxidative stress markers, and adipokines will be evaluated in a subsample. It is expected that DicaBr supplemented with nuts will be superior to DicaBr alone to benefit patients with AMI regarding cardiometabolic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 40 years with previous AMI (60 to 180 days).
排除标准
- •Clinical indication of myocardial revascularization surgery (graf /bypass);
- •HIV positive in treatment/AIDS;
- •Chronic inflammatory diseases;
- •Chemical dependency/alcoholism;
- •Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
- •Pregnancy or lactation;
- •Wheelchair users without conditions of anthropometric evaluation;
- •Extreme obesity (BMI ≥40kg / m²);
- •Use of dietary supplements;
- •Rejection/allergy to oilseed consumption;
- •Participation in other randomized studies at the time of enrollment.
结局指标
主要结局
LDL-c
时间窗: Changes in LDL-c after 16 weeks
Low-density lipoprotein cholesterol (LDL-c), in mg/dL: LDL-c will be detected by Martins´mathematical formula
次要结局
- TC(Changes in TC after 16 weeks)
- NHDL-c(Changes in NHDL-c after 16 weeks)
- Castelli I index(Changes in Castelli I index after 16 weeks)
- Castelli II index(Changes in Castelli II index after 16 weeks)
- HDL-c(Changes in HDL-c after 16 weeks)
- TG/HDL-c(Changes in TG/HDL-c after 16 weeks)
- HbA1C(Changes in HbA1C after 16 weeks)
- WHR(Changes in WHR after 16 weeks)
- TG(Changes in TG after 16 weeks)
- VLDL-c(Changes in VLDL after 16 weeks)
- INS(Changes in INS after 16 weeks)
- HOMA-IR(Changes in HOMA-IR after 16 weeks)
- HC(Changes in HC after 16 weeks)
- FG(Changes in FG after 16 weeks)
- BW(Changes in BW after 16 weeks)
- BMI(Changes in BMI after 16 weeks)
- WC(Changes in WC after 16 weeks)
- WHt(Changes in WHt after 16 weeks)