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NCT03728127: DICA-NUTS

Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

Completed NA Last updated 1 March 2023
What this trial tests

NA trial testing Brazilian cardioprotective diet in Coronary Artery Disease in 488 participants. Completed in 31 December 2022.

Timeline
3 January 2019
Primary endpoint
13 December 2021
31 December 2022

Quick facts

Lead sponsorHospital do Coracao
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment488
Start date3 January 2019
Primary completion13 December 2021
Estimated completion31 December 2022
Sites9 locations across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital do Coracao

Who can join

40 and older, any sex, with Coronary Artery Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronary artery disease (CAD) is the leading cause of death worldwide. Dietary patterns and functional foods may play an important role in the management of cardiovascular risk factors such as overweight and dyslipidemia, as well as inflammation and oxidative stress. However, little is known regarding the effect of diets or specific nutrients on these parameters in individuals with acute myocardial infarction (AMI). The Brazilian Cardioprotective Diet (DicaBr) is based on Brazilian nutritional guidelines and also in a unique and ludic nutritional strategy. In a pilot study, this diet was effective in reducing blood pressure (intragroup comparison) and body weight (intergroup comparison) in individuals with established cardiovascular disease (CVD). However, the effectiveness of this dietary pattern supplemented with different kind of nuts is unknown. The aim of this study is to evaluate the effect of the DicaBr supplemented or not with 30g/day of different nuts on cardiometabolic parameters in patients with recent AMI. In this parallel randomized controlled trial, 388 patients ≥40 years with a recent diagnosis of AMI (60 to 180 days) will be allocated to one of two study groups: 1) DicaBr group (DCB, control group); or 2) DicaBr group supplemented with mixed nuts (DCBN, intervention group). All patients will receive the same dietary prescription, the DCBN group also will receive 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazilian nuts). A pilot study including 100 individuals who will receive only peanuts (30g/day) will be conducted. The primary outcome will be LDL-cholesterol (LDL-c) levels after 16 weeks. In the baseline and at the end of the study (16 weeks), lipid and glycemic profile and anthropometric indexes will be evaluated in both groups; inflammatory and oxidative stress markers, and adipokines will be evaluated in a subsample. It is expected that DicaBr supplemented with nuts will be superior to DicaBr alone to benefit patients with AMI regarding cardiometabolic parameters.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial.
    Marcadenti A, Weber B, Bersch-Ferreira AC, Machado RHV, et al · · 2021 · cited 4× · PMID 34470656 · DOI 10.1186/s13063-021-05494-0
  2. 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.
    Bersch-Ferreira ÂC, Weschenfelder C, Vieira Machado RH, Nakagawa Santos RH, et al · · 2024 · cited 2× · PMID 39354558 · DOI 10.1186/s12937-024-01020-5
  3. Absolute and Relative Agreement between the Current and Modified Brazilian Cardioprotective Nutritional Program Dietary Index (BALANCE DI) and the American Heart Association Healthy Diet Score (AHA-DS) in Post Myocardial Infarction Patients.
    Weschenfelder C, Sapp P, Riley T, Petersen K, et al · · 2022 · cited 1× · PMID 35405989 · DOI 10.3390/nu14071378
  4. Derivation and Validation of a Food Inflammatory Index Calibrated to Brazilian Dietary Patterns in Adults After Acute Myocardial Infarction.
    Dias AR, Bersch-Ferreira AC, Vieira Machado RH, de Abreu-Silva EO, et al · · 2026 · PMID 42182545 · DOI 10.7759/cureus.109280
  5. Supplementation with mixed nuts does not improve inflammatory biomarkers or dietary inflammatory potential in post-myocardial infarction: a secondary analysis of the DICA-NUTS trial.
    Marcadenti A, Bersch-Ferreira AC, Vieira Machado RH, Nakagawa Santos RH, et al · · 2026 · PMID 41856832 · DOI 10.1016/j.numecd.2026.104625
  6. Abstracts from the World Congress of Cardiology/Brazilian Congress of Cardiology 2022
    The Editorial Team (on behalf of the World Heart Federation). · · 2023

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