Trials (Sep 2021)
Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial
- Aline Marcadenti,
- Bernardete Weber,
- Angela Cristine Bersch-Ferreira,
- Rachel Helena Vieira Machado,
- Camila Ragne Torreglosa,
- Enilda Maria de Sousa Lara,
- Lucas Ribeiro da Silva,
- Renato Hideo Nakagawa Santos,
- Debora Harumi Kodama Miyada,
- Erica Regina Ribeiro Sady,
- Rosana Perim Costa,
- Leopoldo Piegas,
- Erlon Oliveira de Abreu-Silva,
- Alexandre Schaan de Quadros,
- Camila Weschenfelder,
- Júlia Lorenzon dos Santos,
- Gabriela Corrêa Souza,
- Suena Medeiros Parahiba,
- Ana Paula Trussardi Fayh,
- Danielle Soares Bezerra,
- Ana Paula Perillo Ferreira Carvalho,
- Malaine Morais Alves Machado,
- Sandra Mary Lima Vasconcelos,
- Jéssika Araújo,
- José Albuquerque de Figueiredo Neto,
- Luciana Pereira Pinto Dias,
- Francisca Eugenia Zaina Nagano,
- Cássia Cristina Paes de Almeida,
- Annie Seixas Bello Moreira,
- Débora Pinto Gapanowicz,
- Eduardo Purgatto,
- Marcelo Macedo Rogero,
- Geni Rodrigues Sampaio,
- Elizabeth Aparecida Ferraz da Silva Torres,
- Graziela Biude Silva Duarte,
- Alexandre Biasi Cavalcanti
Affiliations
- Aline Marcadenti
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Bernardete Weber
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Angela Cristine Bersch-Ferreira
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Rachel Helena Vieira Machado
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Camila Ragne Torreglosa
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Enilda Maria de Sousa Lara
- Health Knowledge Implementation Laboratory (LICS), Hospital do Coração (HCor)
- Lucas Ribeiro da Silva
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Renato Hideo Nakagawa Santos
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Debora Harumi Kodama Miyada
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Erica Regina Ribeiro Sady
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Rosana Perim Costa
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Leopoldo Piegas
- Division of Cardiology, Hospital do Coração (HCor)
- Erlon Oliveira de Abreu-Silva
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- Alexandre Schaan de Quadros
- Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
- Camila Weschenfelder
- Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
- Júlia Lorenzon dos Santos
- Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
- Gabriela Corrêa Souza
- Division of Nutrition, Hospital de Clínicas de Porto Alegre (HCPA)
- Suena Medeiros Parahiba
- Post-Graduation Program in Food, Nutrition and Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS)
- Ana Paula Trussardi Fayh
- Department of Nutrition, Universidade Federal do Rio Grande do Norte (UFRN)
- Danielle Soares Bezerra
- Faculty of Health Science of Trairi, Universidade Federal do Rio Grande do Norte (FACISA-UFRN)
- Ana Paula Perillo Ferreira Carvalho
- Clinical Nutrition Unit, Hospital de Clínicas, Universidade Federal de Goiás (HC-UFG/EBSERH)
- Malaine Morais Alves Machado
- Clinical Nutrition Unit, Hospital de Clínicas, Universidade Federal de Goiás (HC-UFG/EBSERH)
- Sandra Mary Lima Vasconcelos
- Faculty of Nutrition, Universidade Federal de Alagoas (UFAL)
- Jéssika Araújo
- Faculty of Nutrition, Universidade Federal de Alagoas (UFAL)
- José Albuquerque de Figueiredo Neto
- Department of Cardiology, Universidade Federal do Maranhão (UFMA)
- Luciana Pereira Pinto Dias
- Department of Cardiology, Universidade Federal do Maranhão (UFMA)
- Francisca Eugenia Zaina Nagano
- Complexo Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR)
- Cássia Cristina Paes de Almeida
- Universidade Federal do Paraná (UFPR)
- Annie Seixas Bello Moreira
- Instituto Nacional de Cardiologia (INC)
- Débora Pinto Gapanowicz
- Instituto Nacional de Cardiologia (INC)
- Eduardo Purgatto
- Department of Food Science and Experimental Nutrition/Food Research Center, Faculty of Pharmaceutical Sciences, Universidade de São Paulo (USP)
- Marcelo Macedo Rogero
- Department of Nutrition, School of Public Health, Universidade de São Paulo (USP)
- Geni Rodrigues Sampaio
- Department of Nutrition, School of Public Health, Universidade de São Paulo (USP)
- Elizabeth Aparecida Ferraz da Silva Torres
- Department of Nutrition, School of Public Health, Universidade de São Paulo (USP)
- Graziela Biude Silva Duarte
- Department of Food Science and Experimental Nutrition, Faculty of Pharmaceutical Science, Universidade de São Paulo (USP)
- Alexandre Biasi Cavalcanti
- HCor Research Institute (IP-HCor), Hospital do Coração (HCor)
- DOI
- https://doi.org/10.1186/s13063-021-05494-0
- Journal volume & issue
-
Vol. 22,
no. 1
pp. 1 – 16
Abstract
Abstract Background Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DI eta CA rdioprotetora Br asileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI). Methods DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data. Discussion It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br. Trial registration ClinicalTrials.gov Identifier NCT03728127 . First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.
Keywords