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NCT Number: NCT03728127

Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brazilian cardioprotective diet

Dietary Supplement

Brazilian cardioprotective diet prescription

Brazilian cardioprotective diet plus 30g/day of mixed nuts

Dietary Supplement

Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)

Primary outcomes

  1. LDL-c

    Time frame: 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 outcomes

  1. TC

    Time frame: Changes in TC after 16 weeks

    Total cholesterol (TC), in mg/dL

  2. HDL-c

    Time frame: Changes in HDL-c after 16 weeks

    High-density lipoprotein cholesterol (HDL-c), in mg/dL

  3. TG

    Time frame: Changes in TG after 16 weeks

    Serum triglycerides (TG), in mg/dL

  4. VLDL-c

    Time frame: 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

  5. NHDL-c

    Time frame: 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

  6. TG/HDL-c

    Time frame: 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

  7. Castelli I index

    Time frame: 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

  8. Castelli II index

    Time frame: 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

  9. FG

    Time frame: Changes in FG after 16 weeks

    Fasting glucose (FG), in mg/dL

  10. INS

    Time frame: Changes in INS after 16 weeks

    Serum insulin (INS), in mU/L

  11. HbA1C

    Time frame: Changes in HbA1C after 16 weeks

    glycated hemoglobin (HbA1C), in %

  12. HOMA-IR

    Time frame: 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]

  13. BW

    Time frame: Changes in BW after 16 weeks

    Body weight, in kg

  14. BMI

    Time frame: 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

  15. WC

    Time frame: Changes in WC after 16 weeks

    Waist circumference (WC), in cm

  16. HC

    Time frame: Changes in HC after 16 weeks

    Hip circumference, in cm

  17. WHR

    Time frame: 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

  18. WHt

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Acronym: DICA-NUTS

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 1, 2018
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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