NCT03728127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

October 29, 2018

Last Update Submit

February 28, 2023

Conditions

Coronary Artery DiseaseMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • TC

    Changes in TC after 16 weeks

  • HDL-c

    Changes in HDL-c after 16 weeks

  • TG

    Changes in TG after 16 weeks

  • VLDL-c

    Changes in VLDL after 16 weeks

  • NHDL-c

    Changes in NHDL-c after 16 weeks

  • +13 more secondary outcomes

Study Arms (2)

DicaBr group and nuts (DCBN)

EXPERIMENTAL

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

DicaBr group (DCB)

ACTIVE COMPARATOR

Brazilian cardioprotective diet

Dietary Supplement: Brazilian cardioprotective diet

Interventions

Brazilian cardioprotective dietDIETARY_SUPPLEMENT

Brazilian cardioprotective diet prescription

DicaBr group (DCB)
Brazilian cardioprotective diet plus 30g/day of mixed nutsDIETARY_SUPPLEMENT

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

DicaBr group and nuts (DCBN)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Location

Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR)

Curitiba, Brazil

Location

Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG)

Goiânia, Brazil

Location

Universidade Federal de Alagoas (UFAL)

Maceió, Brazil

Location

Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS)

Porto Alegre, Brazil

Location

Instituto Nacional de Cardiologia (INC)

Rio de Janeiro, Brazil

Location

Universidade Federal do Maranhão (UFMA)

São Luís, Brazil

Location

Hospital do Coração (HCor)

São Paulo, Brazil

Location

Related Publications (2)

  • Bersch-Ferreira AC, Weschenfelder C, Vieira Machado RH, Nakagawa Santos RH, Riley TM, da Silva LR, Miyada DHK, Sady ERR, de Abreu-Silva EO, Laranjeira LN, de Quadros AS, Dos Santos JL, Souza GC, Parahiba SM, Fayh APT, Bezerra DS, Carvalho APPF, Machado MMA, Vasconcelos SML, Santos MVR, de Figueiredo Neto JA, Dias LPP, Zaina Nagano FE, de Almeida CCP, Moreira ASB, de Oliveira RD, Rogero MM, Sampaio GR, da Silva Torres EAF, Weber B, Cavalcanti AB, Marcadenti A. Effects of mixed nuts as part of a Brazilian Cardioprotective diet on LDL-cholesterol in adult patients after myocardial infarction: a multicenter randomized controlled clinical trial. Nutr J. 2024 Oct 1;23(1):118. doi: 10.1186/s12937-024-01020-5.

    PMID: 39354558DERIVED

  • 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.

    PMID: 34470656DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Aline Marcadenti, PhD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

  • Alexandre Cavalcanti, PhD

    Hospital do Coracao

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 1, 2018

Study Start

January 3, 2019

Primary Completion

December 13, 2021

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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/

Locations

BR(9)