The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial)

Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; Silva, Jacqueline T. da; Galante, Andrea; Lara, Enilda de Sousa; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Moriguchi, Emílio Hideyuki; Bruscato, Neide Maria; Kesties, Josiele; Vivian, Lilian; Carli, Waldemar de; Backes, Luciano Marcelo; Reolão, Bruna R.; Rodrigues, Milena P.; Baldissera, Dúnnia M.B.; Três, Gláucia Sarturi; Lisboa, Hugo Roberto Kurtz; B.J., João; Reolão, José Basileu Caon; Deucher, Keyla L.A.L.; Cantarelli, Maiara; Lucion, Aline; Rampazzo, Daniela; Bertoni, Vanessa Maria; Torres, Rosileide S.; Verríssimo, Adriana O.L.; Guterres, Aldair S.; Cardos, Andrea F.R.; Coutinho, Dalva B.S.; Negrão, Mayara G.; Alencar, Mônica F.A.; Pinho, Priscila Matos de; Barbosa, Socorro Nazaré Araújo Almeida; Carvalho, Ana Paula Perillo Ferreira; Taboada, Maria I.S.; Pereira, Sheila Alves P.; Heyde, Raul von der; Nagano, Francisca Eugenia Zaina; Baumgartner, Rebecca; Resende, Fernanda P.; Tabalipa, Ranata; Zanini, Ana C.; Machado, Michael J.R.; Araujo, Hevila; Teixeira, Maria Laura Verissimo; Souza, Gabriela Corrêa; Zuchinali, Priccila; Fracasso, Bianca M.; Ulliam, Karen; Schumacher, Marina Verdi; Pierotto, Moara; Hilário, Thamires de Souza; Carlos, Daniele M.O.; Cordeiro, Cintia G.N.C.; Carvalho, Daniele A.; Gonçalves, Marília S.; Vasconcelos, Valdiana B.; Bosquetti, Rosa; Pagano, R.; Romano, Marcelo Luz Pereira; Jardim, César; Abreu, Bernardo N; Marcadenti, Aline; Schmitt, Alessandra R.; Tavares, Ângela Maria Vicente; Faria, Christiane Carvalho; Silva, Flávia Moraes; Fink, Jaqueline S.; Kik, Raquel Milani El; Prates, Clarice F.; Vieira, Cristiane S.; Adorne, Elaine F.; Magedanz, Ellen Hettwer; Chieza, Fernanda Lourega; Silva, Ingrid S.; Teixeira, Joise M.; Trescastro, Eduardo P.; Pellegrini, Livia; Pinto, Jéssika C.; Telles, Cristina T.; Sousa, Antônio Carlos Sobral; Almeida, Andreza Santos; Costa, Ariane A.; Carmo, José A.C.; Silva, Juliana T.; Alves, Luciana Vieira Sousa; Sales, Saulo O.C.; Ramos, María Elena; Lucas, Marilia C.S.; Damiani, Monica; Cardoso, Patrícia Cristina; Ramos, Salvador S.; Dantas, Clenise F.; Lopes, Amanda; Cabral, Ana M.P.; Lucena, Ana C.A.; Medeiros, Auriene L.; Terceiro, Bernardino B.; Leda, Neuma M.F.S.; Baía, Sandra R.D.; Pinheiro, Josilene Maria Ferreira; Cassiano, Alexandra N.; Melo, Andressa N.L.; Cavalcanti, Anny K.O.; Souza, Camila V.S.; Queiroz, Dayanna Joyce Marques; Farias, Hercilla N.C.F.; Souza, Larissa Camila Ferreira; Santos, Letícia Sabino; Lima, Luana R.M.; Hoffmann, Meg S.; Ribeiro, Ana Graziela Araújo; Vasconcelos, Daniel França; Dutra, Eliane Said; Ito, Marina; Neto, José Albuquerque Figueiredo; Santos, Alexsandro F.; Sousa, Rosângela Maria Lopes de; Dias, Luciana Pereira Pinto; Lima, Maria Tereza Medeiros Aureliano de; Modanesi, Victor G.; Teixeira, Adriana Fonseca; Estrada, Luciana C.N.C.D.; Modanesi, Paulo Victor Gomes; Gomes, Adriana B.L.; Rocha, Bárbara Rafaela Santos da; Teti, Cristina; David, Marta M.; Palácio, Bruna M.; G.S., Délcio; Faria, Érica H.S.; Oliveira, Michelle C.F.; Uehara, Rose M.; Sasso, Sandramara; Cadinha, Ana C.A.H.; Pinto, Carla W.M.; Castilhos, Mariana P.; Costa, Mariana Fernandes; Kovacs, Cristiane; Magnoni, Daniel; Silva, Quênia; Germini, Michele Fca; Silva, Renata A. da; Monteiro, Aline S.; Santos, Karina G. dos; Moreira, Priscila; Amparo, Fernanda C.; Paiva, Catharina C.J.; Poloni, Soraia; Russo, Diana da Silva; Silveira, Izabele V.; Moraes, Maria Antonieta; Boklis, Mirena; Cardoso, Quinto I.; Moreira, Annie Seixas Bello; Damaceno, Aline M.S.; Santos, Elisa Maia dos; Dias, Glauber Monteiro; Pinho, Cláudia Porto Sabino; Cavalcanti, Adrilene C.; Bezerra, Amanda Silva de Macêdo; Queiroga, Andrey Vieira de; Rodrigues, Isa Galvão; Leal, Tallita V.; Sahade, Viviane; Amaral, Daniele A.; Souza, Diana S.; Araújo, Givaldo A.; Curvello, Karine Duarte; Heine, Manuella; Barretto, Marília M.S.; Reis, Nailson A.; Vasconcelos, Sandra Mary Lima; Vieira, Danielly C.; Costa, Francisco Assis Lima; Fontes, Jessica M.S.; Neto, Juvenal G.C.; Navarro, Laís Nanci Pereira; Ferreira, Raphaela Costa; Marinho, Patrícia Menezes; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo Gehling; Ferreira, Lauren S.; Borges, Lúcia Rota; Azevedo, Norlai Alves; Martins, Celma M.; Kato, Juliana Tieko; Izar, Maria C.O.; Asoo, Marina T.; Capitani, Mariana Dutilh de; Machado, Valéria A.; Fonzar, Waléria T.; Pinto, Sônia Lopes; Silva, Kellen C.; Gratão, Lúcia Helena Almeida; Machado, Sheila D.; Oliveira, Susane R.U. de; Bressan, Josefina; Caldas, Ana Paula Silva; Lima, Hatanne C.F.M.; Hermsdorff, Helen Hermana Miranda; Saldanha, Tânia M.; Priore, Sílvia Eloíza; Feres, Naoel H.; Neves, Adila de Queiroz; Cheim, Loanda Maria Gomes; Silva, Nilma F.; Reis, Sílvia R.L.; Penafort, Andreza M.; Queirós, Ana Paula O. de; Farias, Geysa Maria Nogueira; Santos, Mônica Lourdes Palomino de los; Ambrozio, Cíntia L.; Camejo, Cirília N.; Santos, Cristiano P. dos; Schirmann, Gabriela S.; Boemo, Jorge L.; Oliveira, Rosane E.C.; LIMA, SABRYNA DICKSAN SILVA MEIRA; Bortolini, Vera M.S.; Matos, Cristina; Barretta, Claiza; Specht, Clarice Maria; Souza, Simone Raimondi de; Arruda, Cristina Silva; Rodrigues, Priscila Aparecida; Berwanger, Otávio

doi:10.1016/j.ahj.2015.08.010

Cited by 36 publications

(44 citation statements)

References 19 publications

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“…A large randomized clinical trial has been recently proposed in patients with CAD based on novel dietary interventions with the potential for low cost and high feasibility for use in Brazil [37]. However, this protocol does not consider genetic differences regarding the interbred Brazilian population.…”

Section: Discussionmentioning

confidence: 99%

Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial

Portal¹,

Markoski²,

Quadros³

et al. 2016

Trials

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BackgroundCardiovascular disease has become a major health problem, and it has been associated with both environmental and genetic factors. Studies have shown that the Mediterranean Diet (MeDiet), or its components such as nuts and olive oil, may be strongly associated with the improvement of cardiovascular risk factors in specific populations. The purpose of the GENUTRI study is to investigate the interaction of genetics with cardiovascular risk factors in a non-Mediterranean population with coronary artery disease (CAD) according to three different diets: rich in pecan nuts, in extra-virgin olive oil or a control diet.Methods/designThe GENUTRI study is a single-center, randomized, open-label, parallel-group, 12-week pragmatic clinical trial conducted in patients aged 40 to 80 years and diagnosed with CAD. A standardized questionnaire will be applied to data collection and a blood sample will be obtained for lipid, glycemic and inflammatory profile evaluation. Polymorphisms in the CD36 and STAT3 genes will be detected using the TaqMan® SNP Genotyping Assay. Patients will be allocated in three groups: group 1: 30 g/day of pecan nuts; group 2: 30 ml/day of olive oil; and group 3: control diet. The primary outcome will consist of changes in LDL-cholesterol (in mg/dl) after 12 weeks of intervention.DiscussionStudies have shown the beneficial effects of diets rich in nuts and olive oil mainly in the Mediterranean population. GENUTRI is a clinical trial focusing on the effects of nuts or olive oil supplementation in Brazilian individuals. Additionally, we will try to demonstrate that genetic polymorphisms linked to cardiovascular disease may modulate the effects of different diets on biochemical and inflammatory markers among these subjects.Trial registrationClinicalTrials.gov Identifier: NCT02202265 (registered on 18 July 2014: first version).

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Section: Discussionmentioning

confidence: 99%

Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial

Portal¹,

Markoski²,

Quadros³

et al. 2016

Trials

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“…The intervention has the main purpose of developing a Brazilian cardioprotective diet that achieves standard nutritional recommendations for treatment of CVD and, concurrently, incorporates local food products to respect regional habits, multi-cultural factors and affordability. The main results of the BALANCE Program were previously published (19)(20)(21) showing diet quality improvement after a 48-months follow-up, but no differences in mortality or cardiovascular events.…”

Section: Introductionmentioning

confidence: 96%

Cost-effectiveness and diet quality in a 3-year follow-up of a randomised controlled trial (The BALANCE trial)

Torreglosa

Sarti

Ferreira

et al. 2020

Preprint

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Background: A healthy diet is essential to reduce cardiovascular disease (CVD) risk and mortality. However, recent studies lack conclusive evidence on the affordability of cardioprotective diets worldwide. The Brazilian Cardioprotective Nutritional Program Trial (BALANCE Program) is a randomized multicenter clinical trial that proposes regionally adapted cardioprotective diet that achieves nutritional recommendations and incorporates accessible and affordable foods. The study aim is to analyze cost-effectiveness of the BALANCE Program in comparison to generic dietary advice for individuals, based on diet costs and nutritional quality among patients with high adherence to the study protocol in both control and intervention groups. Methods: We conducted a cost-effectiveness analysis of subsample from the BALANCE Program (1,161 individuals with previous event of CVD and high adherence to study protocol enrolled in 35 research sites throughout Brazil) after a 3-year follow-up. Direct costs and nutritional quality of diets reported by participants were estimated at the individual level. Diet costs were based on market prices collected from five major supermarket chains. Effectiveness was measured in terms of diet quality, according to adherence to the Brazilian Health Eating Index Revised (BHEI-R). Mean differences were compared between groups using generalized estimating equation. Monte Carlo simulations were performed to comprise probabilistic sensitivity analysis regarding trends in the comparison between groups. Results: At baseline, mean direct diet costs were equal (U$3.9/day), and there were small differences in BHEI-R between groups (53.5 points in BALANCE Program, and 51.8 points in control group). After the 3-year follow-up, the intervention was associated with a mean cost saving of U$0.31/day (95%CI: -0.59; -0.04) and mean BHEI-R increase of 4.38 (95%CI: 2.81; 5.95). The intervention was dominant strategy in terms of cost-effectiveness due to higher effectiveness at lower costs in comparison with the control group. Conclusions : There was a statistically significant effect of the intervention regarding increase in diet quality and reduction in cost after 3 years compared to the control group. The BALANCE intervention may be an option to improve diet quality with lower costs among Brazilians with CVD. Trial registration NCT01620398. Registered June 2012. https://clinicaltrials.gov/ct2/show/NCT01620398

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“…For the analysis of 15 days, the collection of biochemical exams and the second 24HR were carried out. All the data in this study were collected by researchers that had been previously trained through the methodology of data collection developed by DICA Br (15).…”

Section: Methodsmentioning

confidence: 99%

“…DF intake: it was calculated through the collection of two 24HR that were done every 15 days, independently of the day of the week, with the help of a photograph album of foods in home measures developed for the DICA Br study. The computerized system Nutriquanti was used in the analysis of the 24HR (15). DF daily intake was classified as adequate (≥ 25 g/day) or inadequate (≤ 25 g/day) according to the Dietary Guide of the Brazilian Population from 2014, which follows the recommendation of nutrients from the WHO/FAO 2003 (13).…”

Section: Methodsmentioning

confidence: 99%

Intake of fibers and its association with cardiometabolic risk factors in individuals on a secondary prevention for cardiovascular diseases: a multicenter study.

et al. 2017

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Intake of fibers and its association with cardiometabolic risk factors in individuals on a secondary prevention for cardiovascular diseases: a multicenter study ResumenIntroducción: entre las medidas no farmacológicas para la prevención y el tratamiento de enfermedades cardiovasculares (ECV), que representan la principal causa de muerte en el mundo, la ingesta adecuada de fibra dietética (FD) ha mostrado desempeñar un papel importante. Objetivo: evaluar la asociación entre el consumo de FD y los factores de riesgo cardiometabólico en pacientes en prevención secundaria de ECV. Métodos: estudio transversal con datos de referencia de los participantes en el estudio DICA Br pertenecientes a los centros examinadores en los estados de Maranhão (MA), Bahía (BA) y Río de Janeiro (RJ). Se utilizaron medidas sociodemográficas, clínicas, conductuales, antropométricas y el consumo diario de FD de individuos de ambos sexos, con edades ≥ 45 años y manifiesta evidencia de aterosclerosis. La asociación entre en el consumo de FD y los factores de riesgo cardiometabólico se obtuvo por el modelo de regresión de Poisson. Resultados: fueron evaluados 141 sujetos y se observó alta frecuencia de consumo insuficiente de FA. Los participantes de los centros de RJ (RP = 0,63; IC 95% = 0,49-0,80), BA (RP = 0,79; IC 95%: 0,66-0,95), los ex fumadores (RP = 0,59; IC 95% = 0,78-0,45) y los no fumadores (OR = 0,62; IC 95%: 0,66-0,95) eran menos propensos a tener un consumo insuficiente FD. Las personas con sobrepeso mostraron un 28,0% más de probabilidades de tener una ingesta inadecuada de FD. Conclusión: los resultados indicaron que la mayoría de la población observada presentaba una ingesta inadecuada de FD y que el consumo bajo se asoció significativamente con el sobrepeso, el tabaquismo y el centro de desarrollo. AbstractIntroduction: Among the non-pharmacologic measures for the prevention and treatment of cardiovascular diseases (CVD), which are the first cause of death worldwide, the adequate intake of dietary fibers (DF) has shown an important role. Objective: To evaluate the association between the intake of DF and the cardio-metabolic risk factors in individuals on a secondary prevention for CVD. Methods: Transversal study with basal data of the study's DICA Br participants belonging to collaborative centers in the states of Maranhão (MA), Bahia (BA) and Rio de Janeiro (RJ). Sociodemographic and clinical data were used, as well as the daily intake of DF in individuals of both sexes, with age ≥ 45 years and manifest evidence of arteriosclerosis. The association between the intake of dietary fibers and the cardio-metabolic risk factors was obtained through Poisson's regression model. Results: With 141 evaluated individuals, high frequency of non-appropriateness of DF intake was observed. The participants in the centers of RJ (PR = 0.63; CI 95% = 0.49-0.80) and BA (PR = 0.79; CI 95% = 0.66-0.95), former smokers (PR = 0.59; CI 95% = 0.45-0.78) and non-smokers (PR = 0.62; CI 95% = 0.66-0.95) had fewer chances of having non appropriate in...

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The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial)

Cited by 36 publications

References 19 publications

Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial

Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial

Cost-effectiveness and diet quality in a 3-year follow-up of a randomised controlled trial (The BALANCE trial)

Intake of fibers and its association with cardiometabolic risk factors in individuals on a secondary prevention for cardiovascular diseases: a multicenter study.

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