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Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction (DICA-NUTS)

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ClinicalTrials.gov Identifier: NCT03728127
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Infarction Dietary Supplement: Brazilian cardioprotective diet Dietary Supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Brazilian Cardioprotective Diet and Nuts on Cardiometabolic Parameters in Post-acute Myocardial Infarction: a Randomized Clinical Trial (DICA-NUTS Study)
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: DicaBr group and nuts (DCBN)
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
Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)

Active Comparator: DicaBr group (DCB)
Brazilian cardioprotective diet
Dietary Supplement: Brazilian cardioprotective diet
Brazilian cardioprotective diet prescription




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728127


Contacts
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Contact: Aline Marcadenti, PhD (+55)11 30536611 ext 3558 amarcaden@hcor.com.br
Contact: Alexandre Cavalcanti, PhD (+55)11 30536611 ext 8201 abiasi@hcor.com.br

Locations
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Brazil
Universidade Federal do Rio Grande do Norte Active, not recruiting
Natal, Rio Grande Do Norte, Brazil
Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul Active, not recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90620-000
Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR) Recruiting
Curitiba, Brazil
Contact: Francisca Zaina, MSc         
Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG) Active, not recruiting
Goiânia, Brazil
Universidade Federal de Alagoas (UFAL) Active, not recruiting
Maceió, Brazil
Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS) Recruiting
Porto Alegre, Brazil
Contact: Gabriela C Souza, PhD         
Instituto Nacional de Cardiologia (INC) Recruiting
Rio De Janeiro, Brazil
Contact: Annie Bello, PhD         
Universidade Federal do Maranhão (UFMA) Active, not recruiting
São Luís, Brazil
Hospital do Coração (HCor) Recruiting
São Paulo, Brazil
Contact: Aline Marcadenti, PhD         
Sponsors and Collaborators
Hospital do Coracao
Investigators
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Principal Investigator: Aline Marcadenti, PhD Hospital do Coracao
Study Director: Alexandre Cavalcanti, PhD Hospital do Coracao
Study Chair: Bernardete Weber, PhD Hospital do Coracao
Study Chair: Angela Bersh-Ferreira, PhD Hospital do Coracao
Study Chair: Enilda Lara, PhD Hospital do Coracao
Study Chair: Rachel Machado, MSc Hospital do Coracao
Study Chair: Lucas Ribeiro, RD Hospital do Coracao
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT03728127    
Other Study ID Numbers: DICA-NUTS
U1111-1259-8105 ( Other Identifier: Universal Trial Number - World Health Organization (UTN-WHO) )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We intend to submit the Study Protocol as an article.
Supporting Materials: Study Protocol
Time Frame: December 2020
Access Criteria: Will be available after publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases