Brazilian Cardioprotective Nutritional Program Trial

NCT01620398 | Completed

• 1 other identifier: BCDT
• Study Type: interventional
• Target: 2,534
• Locations: 1 country
• Sites: 35

Brief Summary

There are no studies exploring the benefits of a diet composed of typical Brazilian food in the secondary prevention of cardiovascular diseases. Randomized studies show that the Mediterranean diet is beneficial for patients with established cardiovascular disease or in risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of main references for dietary guidelines for treatment and prevention of CVD in Brazil and the world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are not widely available, may be expensive or are not part of population eating habits. So, the prescription of the Mediterranean diet intervention for cardiovascular disease to the Brazilian population may not be feasible, leading to a low adherence. In this context, patients with established CVD have a low compliance to nutritional prescription. The BALANCE Program, considers 3 concepts: a) A dietary prescription guided by nutritional content recommendations from the Brazilian national guidelines; b) A nutritional education program based on fun, playful strategies and suggestions of affordable foods; and c) Intensive follow-up through one-on-one visits, group sessions, and phone calls. This is the first proposal to use these concepts concurrently with the objective to increase adherence of secondary prevention patients to the diet proposed by the guidelines. Therefore, The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina.

Conditions

Cardiovascular Diseases

Keywords

cardiovascular diseases; secondary prevention; diet

Outcome Measures

Primary Outcomes (1)

• Composity of Major Cardiovascular Events

  The primary composite outcome will be the occurrence of any of the following cardiovascular events: cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, cardiovascular death, or death from any cause. The Clinical Endpoints Committee (CEC) will be responsible for adjudication of primary composite outcome components. All suspected events will be entered into the CEC tracking database and independently reviewed by two CEC physicians. If the two adjudicators agree, event adjudication will be considered complete. If there is disagreement, the final decision will be made by a third, independent adjudicator. It will be reported in events per person-years and crude rate per 1000 person-years.

  up to 48 month

Secondary Outcomes (14)

• Total cholesterol (mg/dl)

  up to 48 month

• LDL - cholesterol (mg/dl)

  up to 48 month

• Fasting glucose (mg/dL)

  up to 48 month

• Blood pressure (mmHg)

  up to 48 month

• Body-mass index (kg/m2)

  up to 48 month

Study Arms (2)

BALANCE group

EXPERIMENTAL

BALANCE Program is composed by 3 concepts: a) a diet composed of 50-60% of energy from carbohydrate, 10-15% of energy from protein; 25-35% of energy from fat (\<7% saturated fatty acid; \<10% polyunsaturated fatty acid; \<20% monounsaturated fatty acid, \<1% trans fatty acid), \<200 mg/day of cholesterol, 20-30 g/day of fiber and \<2400 mg/day of sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls.

Behavioral: BALANCE

Control Diet group

ACTIVE COMPARATOR

generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.

Behavioral: Control diet

Interventions

BALANCE BEHAVIORAL

Also known as: DICA Br;, PABC;

BALANCE group

Control diet BEHAVIORAL

Participants will be encourage to follow a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets. They will receive a common folder composed by lists of foods that should be preferred or avoided. For example, avoidance of ultra processed foods, preference for boiled and baked foods rather than fried foods and recommendation of having at least five meals a day. This folder is equivalent of several that are given on ambulatories or hospital of Brazilian public health.

Control Diet group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any evidence of coronary artery disease (CAD) over the preceding 10 years, as defined by any of the following criteria:
• defined by previous myocardial infarction,
• stable or unstable angina,
• history of atherosclerotic stenosis ≥70% of the diameter of any coronary artery on conventional or computed tomographic (CT) coronary angiography,
• history of angioplasty, stenting, or coronary artery bypass surgery)
• Any evidence of stroke in the preceding 10 years
• Peripheral Arterial Disease over the preceding 10 years, as defined by any of the following criteria:
• ankle/arm ratio \<0.9 of systolic blood pressure in either leg at rest, angiography or Doppler demonstrating \>70% stenosis in a cardiac artery,
• intermittent claudication,
• vascular surgery for atherosclerotic disease,
• amputation due to atherosclerotic disease,
• aortic aneurysm

You may not qualify if:

• Refusal to provide Informed Consent Statement
• neurocognitive or psychiatric condition that may hinder collection of reliable clinical data (defined at the trial investigator's discretion)
• Life expectancy less than 6 months
• Pregnancy or lactation
• Liver failure with a history of encephalopathy or anasarca
• Renal Failure with indication for dialysis
• Congestive heart failure
• Previous organ transplantation
• Wheelchair use
• Any restrictions to receiving an oral diet.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (35)

Universidade Federal de Alagoas

Maceió, Alagoas, Brazil

Location

Hospital Universitário Francisca Mendes

Manaus, Amazonas, Brazil

Location

Hospital de Messejana

Fortaleza, Ceará, Brazil

Location

Universidade de Fortaleza

Fortaleza, Ceará, Brazil

Location

Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA

Salvador, Estado de Bahia, Brazil

Location

Hospital das Clínicas de Goiânia

Goiânia, Goiás, 90630000, Brazil

Location

Hospital Universitário Federal Presidente Dutra

São Luiz, Maranhão, Brazil

Location

Universidade Federal do Mato Grosso

Cuiabá, Mato Grosso, Brazil

Location

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, Brazil

Location

Universidade Federal de Viçosa

Viçosa, Minas Gerais, Brazil

Location

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

Location

Hospital Universitário Alcides Carneiro

Campina Grande, Paraíba, Brazil

Location

Hospital das Clínicas Gaspar Viana

Belém, Pará, Brazil

Location

Pronto Socorro Cardiológico Universitário de Pernambuco

Recife, Pernambuco, Brazil

Location

IECAC

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Universitário Ana Bezerra

Santa Cruz, Rio Grande do Norte, Brazil

Location

URCAMP

Bagé, Rio Grande do Sul, Brazil

Location

Hospital Universitário AESC

Canoas, Rio Grande do Sul, 90630000, Brazil

Location

BIOSERV

Passo Fundo, Rio Grande do Sul, 90630000, Brazil

Location

Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, Brazil

Location

COTENUT

Porto Alegre, Rio Grande do Sul, 90630000, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90630000, Brazil

Location

Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90630000, Brazil

Location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Associação Veranense de Assistência em Saúde (AVAES)

Veranópolis, Rio Grande do Sul, 90630000, Brazil

Location

Universidade Vale do Itajaí

Itajaí, Santa Catarina, Brazil

Location

Hospital São Lucas

Aracaju, Sergipe, Brazil

Location

Hospital Universitário FUFSE

Aracaju, Sergipe, Brazil

Location

Universidade Federal de Tocantins

Palmas, Tocantins, Brazil

Location

Hospital Universitário de Brasília

Brasília, Brazil

Location

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Brazil

Location

Instituto Nacional de Cardiologia

Rio de Janeiro, Brazil

Location

Hospital do Coração

São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Universidade Federal de São Paulo

São Paulo, Brazil

Location

Related Publications (8)

• Almeida AP, Lopes LJ, Bersch-Ferreira AC, Torreglosa CR, Marcadenti A, Weber B, Bressan J, Hermsdorff HHM. Insulin resistance mediate the association between leucine intake, dietary glycemic index, and type 2 diabetes in secondary cardiovascular prevention: path analysis from Brazilian cardioprotective nutritional (BALANCE) program. Eur J Nutr. 2025 Mar 29;64(3):140. doi: 10.1007/s00394-025-03653-6.

  PMID: 40156624 DERIVED

• Bersch-Ferreira AC, Hall WL, Santos RHN, Torreglosa CR, Sampaio G, Tereza da Silva J, Alves R, Ross MB, Gehringer MO, Kovacs C, Marcadenti A, Magnoni D, Weber B, Rogero MM. The effect of the a regional cardioprotective nutritional program on inflammatory biomarkers and metabolic risk factors in secondary prevention for cardiovascular disease, a randomised trial. Clin Nutr. 2021 Jun;40(6):3828-3835. doi: 10.1016/j.clnu.2021.04.035. Epub 2021 Apr 28.

  PMID: 34130029 DERIVED

• de Brito Goncalves Nascimento L, Sahade V, Weber B, Pinheiro JMF, Dias LPP, Figueiredo Neto JA, Carlos Sobral Sousa A, Pinho CPS, Luna AB, Vasconcelos SML, Dantas CF, Penafort AM, Carlos DMO, Daltro C. Diabetic Patients with Cardiovascular Disease Show More Metabolic Syndrome than Nondiabetic Patients: Multicentric Study in the Northeast of Brazil. Metab Syndr Relat Disord. 2021 May;19(4):233-239. doi: 10.1089/met.2020.0064. Epub 2021 Feb 1.

  PMID: 33523760 DERIVED

• Alves da Silva R, Bersch-Ferreira AC, Gehringer MO, Ross-Fernandes MB, Kovacs do Amaral C, Lin Wang HT, Lima PH, de Lima PA, Franca JI, Weber B, Magnoni CD, Rogero MM. Effect of qualitative and quantitative nutritional plan on gene expression in obese patients in secondary prevention for cardiovascular disease. Clin Nutr ESPEN. 2021 Feb;41:351-359. doi: 10.1016/j.clnesp.2020.11.002. Epub 2020 Nov 26.

  PMID: 33487289 DERIVED

• Weber B, Bersch-Ferreira AC, Torreglosa CR, Marcadenti A, Lara ES, da Silva JT, Costa RP, Santos RHN, Berwanger O, Bosquetti R, Pagano R, Mota LGS, de Oliveira JD, Soares RM, Galante AP, da Silva SA, Zampieri FG, Kovacs C, Amparo FC, Moreira P, da Silva RA, Dos Santos KG, Monteiro AS, Paiva CCJ, Magnoni CD, Moreira ASB, Pecanha DO, Missias KCS, de Paula LS, Marotto D, Souza P, Martins PRT, Dos Santos EM, Santos MR, Silva LP, Torres RS, Barbosa SNAA, de Pinho PM, de Araujo SHA, Verissimo AOL, Guterres AS, Cardoso AFR, Palmeira MM, de Ataide BRB, Costa LPS, Marinho HA, de Araujo CBP, Carvalho HMS, Maquine RO, Caiado AC, de Matos CH, Barretta C, Specht CM, Onofrei M, Bertacco RTA, Borges LR, Bertoldi EG, Longo A, Ribas BLP, Dobke F, Pretto ADB, Bachettini NP, Gastaud A, Necchi R, Souza GC, Zuchinali P, Fracasso BM, Bobadra S, Sangali TD, Salamoni J, Garlini LM, Shirmann GS, de Los Santos MLP, Bortonili VMS, Dos Santos CP, Braganca GCM, Ambrozio CL, E Lima SB, Schiavini J, Napparo AS, Boemo JL, Nagano FEZ, Modanese PVG, Cunha NM, Frehner C, da Silva LF, Formentini FS, Ramos MEM, Ramos SS, Lucas MCS, Machado BG, Ruschel KB, Beiersdorf JR, Nunes CE, Rech RL, Damiani M, Berbigier M, Poloni S, Vian I, Russo DS, Rodrigues JA, de Moraes MAP, da Costa LM, Boklis M, El Kik RM, Adorne EF, Teixeira JM, Trescastro EP, Chiesa FL, Telles CT, Pellegrini LA, Reis LF, Cardoso RGM, Closs VE, Feres NH, da Silva NF, Silva NE, Dutra ES, Ito MK, Lima MEP, Carvalho APPF, Taboada MIS, Machado MMA, David MM, Junior DGS, Dourado C, Fagundes VCFO, Uehara RM, Sasso S, Vieira JSO, de Oliveira BAS, Pereira JL, Rodrigues IG, Pinho CPS, Sousa ACS, Almeida AS, de Jesus MT, da Silva GB, Alves LVS, Nascimento VOG, Vieira SA, Coura AGL, Dantas CF, Leda NMFS, Medeiros AL, Andrade ACL, Pinheiro JMF, de Lima LRM, Sabino LS, de Souza CVS, Vasconcelos SML, Costa FA, Ferreira RC, Cardoso IB, Navarro LNP, Ferreira RB, Junior AES, Silva MBG, Almeida KMM, Penafort AM, de Queiros APO, Farias GMN, Carlos DMO, Cordeiro CGNC, Vasconcelos VB, de Araujo EMVMC, Sahade V, Ribeiro CSA, Araujo GA, Goncalves LB, Teixeira CS, Silva LMAJ, da Costa LB, Souza TS, de Jesus SO, Luna AB, da Rocha BRS, Santos MA, Neto JAF, Dias LPP, Cantanhede RCA, Morais JM, Duarte RCL, Barbosa ECB, Barbosa JMA, de Sousa RML, Dos Santos AF, Teixeira AF, Moriguchi EH, Bruscato NM, Kesties J, Vivian L, de Carli W, Shumacher M, Izar MCO, Asoo MT, Kato JT, Martins CM, Machado VA, Bittencourt CRO, de Freitas TT, Sant'Anna VAR, Lopes JD, Fischer SCPM, Pinto SL, Silva KC, Gratao LHA, Holzbach LC, Backes LM, Rodrigues MP, Deucher KLAL, Cantarelli M, Bertoni VM, Rampazzo D, Bressan J, Hermsdorff HHM, Caldas APS, Felicio MB, Honorio CR, da Silva A, Souza SR, Rodrigues PA, de Meneses TMX, Kumbier MCC, Barreto AL, Cavalcanti AB. Implementation of a Brazilian Cardioprotective Nutritional (BALANCE) Program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicenter trial. Am Heart J. 2019 Sep;215:187-197. doi: 10.1016/j.ahj.2019.06.010. Epub 2019 Jun 21.

  PMID: 31349110 DERIVED

• da Silva A, Caldas APS, Hermsdorff HHM, Bersch-Ferreira AC, Torreglosa CR, Weber B, Bressan J. Triglyceride-glucose index is associated with symptomatic coronary artery disease in patients in secondary care. Cardiovasc Diabetol. 2019 Jul 11;18(1):89. doi: 10.1186/s12933-019-0893-2.

  PMID: 31296225 DERIVED

• Tereza da Silva J, Bersch-Ferreira AC, Torreglosa CR, Weber B, Levy RB. Development of a dietary index based on the Brazilian Cardioprotective Nutritional Program (BALANCE). Nutr J. 2018 May 4;17(1):49. doi: 10.1186/s12937-018-0359-5.

  PMID: 29728114 DERIVED

• Weber B, Bersch-Ferreira AC, Torreglosa CR, Ross-Fernandes MB, da Silva JT, Galante AP, Lara Ede S, Costa RP, Soares RM, Cavalcanti AB, Moriguchi EH, Bruscato NM, Kesties, Vivian L, Schumacher M, de Carli W, Backes LM, Reolao BR, Rodrigues MP, Baldissera DM, Tres GS, Lisboa HR, Bem JB, Reolao JB, Deucher KL, Cantarelli M, Lucion A, Rampazzo D, Bertoni V, Torres RS, Verrissimo AO, Guterres AS, Cardos AF, Coutinho DB, Negrao MG, Alencar MF, Pinho PM, Barbosa SN, Carvalho AP, Taboada MI, Pereira SA, Heyde RV, Nagano FE, Baumgartner R, Resende FP, Tabalipa R, Zanini AC, Machado MJ, Araujo H, Teixeira ML, Souza GC, Zuchinali P, Fracasso BM, Ulliam K, Schumacher M, Pierotto M, Hilario T, Carlos DM, Cordeiro CG, Carvalho DA, Goncalves MS, Vasconcelos VB, Bosquetti R, Pagano R, Romano ML, Jardim CA, de Abreu BN, Marcadenti A, Schmitt AR, Tavares AM, Faria CC, Silva FM, Fink JS, El Kik RM, Prates CF, Vieira CS, Adorne EF, Magedanz EH, Chieza FL, Silva IS, Teixeira JM, Trescastro EP, Pellegrini LA, Pinto JC, Telles CT, Sousa AC, Almeida AS, Costa AA, Carmo JA, Silva JT, Alves LV, Sales SO, Ramos ME, Lucas MC, Damiani M, Cardoso PC, Ramos SS, Dantas CF, Lopes AG, Cabral AM, Lucena AC, Medeiros AL, Terceiro BB, Leda NM, Baia SR, Pinheiro JM, Cassiano AN, Melo AN, Cavalcanti AK, Souza CV, Queiroz DJ, Farias HN, Souza LC, Santos LS, Lima LR, Hoffmann MS, Ribeiro AS, Vasconcelos DF, Dutra ES, Ito MK, Neto JA, Santos AF, Sousa RM, Dias LP, Lima MT, Modanesi VG, Teixeira AF, Estrada LC, Modanesi PV, Gomes AB, Rocha BR, Teti C, David MM, Palacio BM, Junior DG, Faria EH, Oliveira MC, Uehara RM, Sasso S, Moreira AS, Cadinha AC, Pinto CW, Castilhos MP, Costa M, Kovacs C, Magnoni D, Silva Q, Germini MF, da Silva RA, Monteiro AS, dos Santos KG, Moreira P, Amparo FC, Paiva CC, Poloni S, Russo DS, Silveira IV, Moraes MA, Boklis M, Cardoso QI, Moreira AS, Damaceno AM, Santos EM, Dias GM, Pinho CP, Cavalcanti AC, Bezerra AS, Queiroga AV, Rodrigues IG, Leal TV, Sahade V, Amaral DA, Souza DS, Araujo GA, Curvello K, Heine M, Barretto MM, Reis NA, Vasconcelos SM, Vieira DC, Costa FA, Fontes JM, Neto JG, Navarro LN, Ferreira RC, Marinho PM, Abib RT, Longo A, Bertoldi EG, Ferreira LS, Borges LR, Azevedo NA, Martins CM, Kato JT, Izar MC, Asoo MT, de Capitani MD, Machado VA, Fonzar WT, Pinto SL, Silva KC, Gratao LH, Machado SD, de Oliveira SR, Bressan J, Caldas AP, Lima HC, Hermsdorff HH, Saldanha TM, Priore SE, Feres NH, Neves Ade Q, Cheim LM, Silva NF, Reis SR, Penafort AM, de Queiros AP, Farias GM, de los Santos ML, Ambrozio CL, Camejo CN, dos Santos CP, Schirmann GS, Boemo JL, Oliveira RE, Lima SM, Bortolini VM, Matos CH, Barretta C, Specht CM, de Souza SR, Arruda CS, Rodrigues PA, Berwanger O. The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial). Am Heart J. 2016 Jan;171(1):73-81.e1-2. doi: 10.1016/j.ahj.2015.08.010. Epub 2015 Aug 15.

  PMID: 26699603 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

4-azidobenzylcarazolol

Study Officials

• Bernardete Berwanger, NC, PhD

  Hospital do Coração

  PRINCIPAL INVESTIGATOR

• Otávio Berwanger, MD, PhD

  Hospital do Coração

  STUDY DIRECTOR

• Rafael M Soares, NC, MSc

  Hospital do Coração

  STUDY CHAIR

• Rosana P Costa, NC, MSc

  Hospital do Coração

  STUDY CHAIR

• Maria B Ross-Fernandes, NC, MSc

  Hospital do Coração

  STUDY CHAIR

• Enilda S Lara, NC, PhD

  Hopsital do Coração

  STUDY CHAIR

• Camila R Torreglosa, NC, MSc

  Hospital do Coração

  STUDY CHAIR

• Ângela C Bersch-Ferreira, NC, MSc

  Hospital do Coração

  STUDY CHAIR

• Jacqueline T da Silva, NC

  Hospital do Coração

  STUDY CHAIR

• Andrea P Galante, NC, PhD

  Hospital do Coração

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: March 5, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (35)