Randomized Controlled Trial
doi: 10.1186/s12937-024-01020-5.
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
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- PMID: 39354558
- PMCID: PMC11445998
- DOI: 10.1186/s12937-024-01020-5
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Randomized Controlled Trial
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.
.
Abstract
Background: Nuts consumption is related to cardioprotective effects on primary cardiovascular prevention, but studies conducted in secondary prevention are small, scarce and controversial. The objective of this trial was to evaluate the effects of a regional and sustainable cardioprotective diet added or not with an affordable mixed nuts on cardiometabolic features in patients with previous myocardial infarction.
Methods: DICA-NUTS study is a national, multi-center, and superiority-parallel randomized clinical trial. Males and females over 40 years old diagnosed with previous myocardial infarction in the last 2 to 6 months were included. Patients were allocated into two groups: the Brazilian Cardioprotective diet (DICA Br) supplemented with 30 g/day of mixed nuts (10 g of peanuts; 10 g of cashew; 10 g of Brazil nuts) (intervention group, n = 193); or only DICA Br prescription (control group, n = 195). The primary outcome was low-density lipoprotein cholesterol means (in mg/dL) after 16 weeks. Secondary outcomes were other lipid biomarkers, glycemic and anthropometric data and diet quality.
Results: After adjustment for baseline values, participating study site, time since myocardial infarction and statin treatment regimen (high potency, moderate and low potency/no statins), no significant difference was found between the groups in low-density lipoprotein cholesterol concentrations (intervention-control difference: 3.48 mg/dL [-3.45 to 10.41], P = 0.32). Both groups improved their overall diet quality at the end of the study without differences between them after 16 weeks (intervention-control difference: 1.05 (-0.9 to 2.99); P = 0.29). Other lipids, glycemic profile and anthropometrics were also not different between study groups at the end of the study.
Conclusion: Adding 30 g/day of mixed nuts to the DICA Br for 16 weeks did not change lipid, glycemic and anthropometric features in the post-myocardial infarction setting.
Trial registration: This study is registered on ClinicalTrials.gov website under number NCT03728127 and its World Health Organization Universal Trial Number (WHO-UTN) is U1111-1259-8105.
Keywords: Cholesterol, LDL; Diet, Healthy; Myocardial Infarction; Nuts; Randomized Controlled Trial [Publication Type].
© 2024. The Author(s).
Conflict of interest statement
The authors declare no competing interests.
Figures
DICA-NUTS study flowchart. MI: myocardial infarction; AIDS: acquired immunodeficiency syndrome; CABG: coronary artery bypass graft surgery; BMI: body mass index; ITT: intention-to-treat
Subgroup analyses on DICA-NUTS trial regarding low-density lipoprotein cholesterol levels (LDL-c, primary outcome) after 16 weeks of follow up. MI: myocardial infarction; STEMI: ST-Elevation MI. Type of MI was obtained from medical records; previous medical diagnosis (stroke, type-2 diabetes mellitus, hypertension, and dyslipidemia) were self-reported
References
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- Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation. 2011;124(22):2458–73 Erratum in: Circulation. 2015; 131(15):e408. - PubMed
-
- Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44(38):3720–826. - PubMed
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- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
- NUPs: 25000.009770/2018-86 and 25000.184506/2020-45/Hcor as part of the "Hospitais de Excelência a Serviço do SUS", in partnership with the Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) and Brazilian Ministry of Health. The sponsor had no role in study design; collection, management, analysis, and interpretation of data; and writing of the report.
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