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

DOI
https://doi.org/10.1186/s13063-021-05494-0
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 16

Abstract

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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.

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