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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728127
Recruitment Status : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date March 9, 2022
Actual Study Start Date  ICMJE January 3, 2019
Actual Primary Completion Date December 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
LDL-c [ Time Frame: Changes in LDL-c after 16 weeks ]
Low-density lipoprotein cholesterol (LDL-c), in mg/dL
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • TC [ Time Frame: Changes in TC after 16 weeks ]
    Total cholesterol (TC), in mg/dL
  • HDL-c [ Time Frame: Changes in HDL-c after 16 weeks ]
    High-density lipoprotein cholesterol (HDL-c), in mg/dL
  • TG [ Time Frame: Changes in TG after 16 weeks ]
    Serum triglycerides (TG), in mg/dL
  • 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
  • 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
  • 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
  • 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
  • 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
  • FG [ Time Frame: Changes in FG after 16 weeks ]
    Fasting glucose (FG), in mg/dL
  • INS [ Time Frame: Changes in INS after 16 weeks ]
    Serum insulin (INS), in mU/L
  • HbA1C [ Time Frame: Changes in HbA1C after 16 weeks ]
    glycated hemoglobin (HbA1C), in %
  • 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]
  • BW [ Time Frame: Changes in BW after 16 weeks ]
    Body weight, in kg
  • 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
  • WC [ Time Frame: Changes in WC after 16 weeks ]
    Waist circumference (WC), in cm
  • HC [ Time Frame: Changes in HC after 16 weeks ]
    Hip circumference, in cm
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • TC [ Time Frame: Changes in TC after 16 weeks ]
    total cholesterol (TC), in mg/dL
  • HDL-c [ Time Frame: Changes in HDL-c after 16 weeks ]
    high-density lipoprotein cholesterol (HDL-c), in mg/dL
  • TG [ Time Frame: Changes in TG after 16 weeks ]
    Serum triglycerides (TG), in mg/dL
  • FG [ Time Frame: Changes in FG after 16 weeks ]
    Fasting glucose (FG), in mg/dL
  • HbA1C [ Time Frame: Changes in HbA1C after 16 weeks ]
    glycated hemoglobin (HbA1C), in %
  • INS [ Time Frame: Changes in INS after 16 weeks ]
    Serum insulin (INS), in mU/L.
  • BMI [ Time Frame: Changes in BMI after 16 weeks ]
    Body mass index (BMI), in kg/m^2; weight and height will be combined to report BMI in kg/m^2
  • WC [ Time Frame: Changes in WC after 16 weeks ]
    Waist circumference (WC), in cm;
  • WHR [ Time Frame: Changes in WHR after 16 weeks ]
    Waist-to-hip ratio (WHR); waist circumference and hip circumference will be combined to report WHR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction
Official Title  ICMJE Effect of the Brazilian Cardioprotective Diet and Nuts on Cardiometabolic Parameters in Post-acute Myocardial Infarction: a Randomized Clinical Trial (DICA-NUTS Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Infarction
Intervention  ICMJE
  • Dietary Supplement: Brazilian cardioprotective diet
    Brazilian cardioprotective diet prescription
  • 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)
Study Arms  ICMJE
  • 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)
    Intervention: Dietary Supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts
  • Active Comparator: DicaBr group (DCB)
    Brazilian cardioprotective diet
    Intervention: Dietary Supplement: Brazilian cardioprotective diet
Publications * Marcadenti A, Weber B, Bersch-Ferreira AC, Machado RHV, Torreglosa CR, de Sousa Lara EM, da Silva LR, Santos RHN, Miyada DHK, Sady ERR, Costa RP, Piegas L, de Abreu-Silva EO, de Quadros AS, Weschenfelder C, Dos Santos JL, Souza GC, Parahiba SM, Fayh APT, Bezerra DS, Carvalho APPF, Machado MMA, Vasconcelos SML, Araujo J, de Figueiredo Neto JA, Dias LPP, Nagano FEZ, de Almeida CCP, Moreira ASB, Gapanowicz DP, Purgatto E, Rogero MM, Sampaio GR, da Silva Torres EAF, Duarte GBS, Cavalcanti AB. Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial. Trials. 2021 Sep 1;22(1):582. doi: 10.1186/s13063-021-05494-0. Erratum In: Trials. 2021 Sep 29;22(1):668.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 12, 2021)
488
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
600
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date December 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728127
Other Study ID Numbers  ICMJE DICA-NUTS
U1111-1259-8105 ( Other Identifier: Universal Trial Number - World Health Organization (UTN-WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.
Supporting Materials: Study Protocol
Time Frame: Data will be available after the main paper publication.
Access Criteria:

Link for design paper (study protocol):

https://pubmed.ncbi.nlm.nih.gov/34470656/

Current Responsible Party Hospital do Coracao
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospital do Coracao
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital do Coracao
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP