Coronary Artery Disease, Myocardial Infarction
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBrazilian cardioprotective diet
Brazilian cardioprotective diet prescription
DIETARY_SUPPLEMENTBrazilian cardioprotective diet plus 30g/day of mixed nuts
Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)
Sponsors
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients ≥ 40 years with previous AMI (60 to 180 days).
Exclusion criteria
* Clinical indication of myocardial revascularization surgery (graf /bypass); * HIV positive in treatment/AIDS; * Chronic inflammatory diseases; * Cancer; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-c | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | Changes in HbA1C after 16 weeks | glycated hemoglobin (HbA1C), in % |
| TC | Changes in TC after 16 weeks | Total cholesterol (TC), in mg/dL |
| HDL-c | Changes in HDL-c after 16 weeks | High-density lipoprotein cholesterol (HDL-c), in mg/dL |
| TG | Changes in TG after 16 weeks | Serum triglycerides (TG), in mg/dL |
| VLDL-c | Changes in VLDL after 16 weeks | Very low-density lipoprotein cholesterol (VLDL-c), in mg/dL; serum triglycerides, (in mg/dL) divided by 5 will be used to report VLDL-c in mg/dL |
| NHDL-c | Changes in NHDL-c after 16 weeks | Non-HDL cholesterol (NHDL-c), in md/dL; total cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report NHDL-c in mg/dL |
| TG/HDL-c | Changes in TG/HDL-c after 16 weeks | TG/HDL-c ratio (TG/HDL-c), in mg/dL; serum triglycerides (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report TG/HDL-c in mg/dL |
| Castelli I index | Changes in Castelli I index after 16 weeks | TC/HDL-c ratio, in mg/dL; total cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report Castelli I index in mg/dL |
| INS | Changes in INS after 16 weeks | Serum insulin (INS), in mU/L |
| FG | Changes in FG after 16 weeks | Fasting glucose (FG), in mg/dL |
| HOMA-IR | Changes in HOMA-IR after 16 weeks | Homeostasis model assessment-insulin resistance, defined according to: \[FG (in mmol) x INS (in UI/mL) ÷ 22.5\] |
| BW | Changes in BW after 16 weeks | Body weight, in kg |
| BMI | Changes in BMI after 16 weeks | Body mass index (BMI), in kg/m\^2; weight (in kg) and height (in meters) will be combined to report BMI in kg/m\^2 |
| WC | Changes in WC after 16 weeks | Waist circumference (WC), in cm |
| HC | Changes in HC after 16 weeks | Hip circumference, in cm |
| WHR | Changes in WHR after 16 weeks | Waist-to-hip ratio (WHR); waist circumference (in cm) and hip circumference (in cm) will be combined to report WHR |
| WHt | Changes in WHt after 16 weeks | Waist-to-height ratio (WHt); waist circumference (in cm) and height (in meters) will be combined to report WtH, in cm/m |
| Castelli II index | Changes in Castelli II index after 16 weeks | LDL-c/HDL-c ratio, in mg/dL; low-density lipoprotein cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report Castelli II index in mg/dL |
Countries
Brazil
Outcome results
None listed