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

• ClinicalTrials.gov Identifier: NCT03728127
• Recruitment Status: Active, not recruiting
• First Posted: November 1, 2018
• Last Update Posted: March 9, 2022
• Sponsor: Hospital do Coracao
• Information provided by (Responsible Party): Hospital do Coracao

Tracking Information

• First Submitted Date: October 29, 2018
• First Posted Date: November 1, 2018
• Last Update Posted Date: March 9, 2022
• Actual Study Start Date: January 3, 2019
• Actual Primary Completion Date: December 13, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 31, 2018)

LDL-c [ Time Frame: Changes in LDL-c after 16 weeks ]

Low-density lipoprotein cholesterol (LDL-c), in mg/dL

Current Secondary Outcome Measures (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 (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: Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction
• 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)
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Coronary Artery Disease
• Myocardial Infarction

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 12, 2021): 488
• Original Estimated Enrollment (submitted: October 31, 2018): 600
• Estimated Study Completion Date: December 31, 2022
• Actual Primary Completion Date: December 13, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT03728127
• Other Study ID Numbers: 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

• 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: Hospital do Coracao
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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