Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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Effect of the Brazilian Cardioprotective Diet and Nuts on Cardiometabolic Parameters in Post-acute Myocardial Infarction: a Randomized Clinical Trial (DICA-NUTS Study)

Conditions
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Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Dietary Supplement: Brazilian cardioprotective diet
* Dietary Supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DicaBr group and nuts (DCBN)<br>Brazilian cardioprotective diet plus 30g/day of mixed nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts) | Dietary Supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts<br>* Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)<br>|
| Active Comparator: DicaBr group (DCB)<br>Brazilian cardioprotective diet | Dietary Supplement: Brazilian cardioprotective diet<br>* Brazilian cardioprotective diet prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-c | Low-density lipoprotein cholesterol (LDL-c), in mg/dL: LDL-c will be detected by Martins´mathematical formula | Changes in LDL-c after 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TC | Total cholesterol (TC), in mg/dL | Changes in TC after 16 weeks | 
| HDL-c | High-density lipoprotein cholesterol (HDL-c), in mg/dL | Changes in HDL-c after 16 weeks | 
| TG | Serum triglycerides (TG), in mg/dL | Changes in TG after 16 weeks | 
| VLDL-c | 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 | Changes in VLDL after 16 weeks | 
| NHDL-c | 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 | Changes in NHDL-c after 16 weeks | 
| TG/HDL-c | 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 | Changes in TG/HDL-c after 16 weeks | 
| Castelli I index | 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 | Changes in Castelli I index after 16 weeks | 
| Castelli II index | 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 | Changes in Castelli II index after 16 weeks | 
| FG | Fasting glucose (FG), in mg/dL | Changes in FG after 16 weeks | 
| INS | Serum insulin (INS), in mU/L | Changes in INS after 16 weeks | 
| HbA1C | glycated hemoglobin (HbA1C), in % | Changes in HbA1C after 16 weeks | 
| HOMA-IR | Homeostasis model assessment-insulin resistance, defined according to: [FG (in mmol) x INS (in UI/mL) ÷ 22.5] | Changes in HOMA-IR after 16 weeks | 
| BW | Body weight, in kg | Changes in BW after 16 weeks | 
| BMI | 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 | Changes in BMI after 16 weeks | 
| WC | Waist circumference (WC), in cm | Changes in WC after 16 weeks | 
| HC | Hip circumference, in cm | Changes in HC after 16 weeks | 
| WHR | Waist-to-hip ratio (WHR); waist circumference (in cm) and hip circumference (in cm) will be combined to report WHR | Changes in WHR after 16 weeks | 
| WHt | Waist-to-height ratio (WHt); waist circumference (in cm) and height (in meters) will be combined to report WtH, in cm/m | Changes in WHt after 16 weeks |