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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Dietary supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts; Dietary supplement: Brazilian cardioprotective diet

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, Brazil
    • Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR)
  • Goiânia, Brazil
    • Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG)
  • Maceió, Brazil
    • Universidade Federal de Alagoas (UFAL)
  • Porto Alegre, Brazil
    • Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS)
  • Rio De Janeiro, Brazil
    • Instituto Nacional de Cardiologia (INC)
  • São Luís, Brazil
    • Universidade Federal do Maranhão (UFMA)
  • São Paulo, Brazil
    • Hospital do Coração (HCor)
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil
      • Universidade Federal do Rio Grande do Norte
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-000
      • Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: DICA-NUTS; U1111-1259-8105 (Other Identifier: Universal Trial Number - World Health Organization (UTN-WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will be available after the main paper publication.

IPD Sharing Access Criteria

Link for design paper (study protocol):

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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No