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.

Publisher: BioMed Central Country of Publication: England NLM ID: 101152213 Publication Model: Electronic Cited Medium: Internet ISSN: 1475-2891 (Electronic) Linking ISSN: 14752891 NLM ISO Abbreviation: Nutr J Subsets: MEDLINE

Original Publication: London : BioMed Central, 2002-

Myocardial Infarction* ; Cholesterol, LDL*/blood ; Nuts*; Humans ; Male ; Female ; Middle Aged ; Brazil ; Diet/methods ; Diet/statistics & numerical data ; Adult ; Aged

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.
(© 2024. The Author(s).)

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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.

Keywords: Cholesterol, LDL; Diet, Healthy; Myocardial Infarction; Nuts; Randomized Controlled Trial [Publication Type]

ClinicalTrials.gov NCT03728127

0 (Cholesterol, LDL)

Date Created: 20241001 Date Completed: 20241002 Latest Revision: 20241029

20250114

PMC11445998

10.1186/s12937-024-01020-5

39354558