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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1259-8105 | Other Identifier | Universal Trial Number - World Health Organization (UTN-WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DicaBr group and nuts (DCBN) | Experimental | Brazilian cardioprotective diet plus 30g/day of mixed nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts) |
|
| DicaBr group (DCB) | Active Comparator | Brazilian cardioprotective diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brazilian cardioprotective diet | Dietary Supplement | Brazilian cardioprotective diet prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-c | Low-density lipoprotein cholesterol (LDL-c), in mg/dL: LDL-c will be detected by Martins´mathematical formula | Changes in LDL-c after 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| TC | Total cholesterol (TC), in mg/dL | Changes in TC after 16 weeks |
| HDL-c | High-density lipoprotein cholesterol (HDL-c), in mg/dL | Changes in HDL-c after 16 weeks |
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Inclusion Criteria: Patients ≥ 40 years with previous AMI (60 to 180 days).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aline Marcadenti, PhD | Hospital do Coracao | Principal Investigator |
| Alexandre Cavalcanti, PhD | Hospital do Coracao | Study Director |
| Bernardete Weber, PhD | Hospital do Coracao | Study Chair |
| Angela Bersh-Ferreira, PhD | Hospital do Coracao | Study Chair |
| Enilda Lara, PhD | Hospital do Coracao | Study Chair |
| Rachel Machado, MSc | Hospital do Coracao | Study Chair |
| Lucas Ribeiro, RD | Hospital do Coracao | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Rio Grande do Norte | Natal | Rio Grande do Norte | Brazil | |||
| Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41856832 | Derived | Marcadenti A, Bersch-Ferreira AC, Vieira Machado RH, Nakagawa Santos RH, de Abreu-Silva EO, da Silva A, Stein E, Bressan J, Hebert JR, Zhao L, Rogero MM. 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. Nutr Metab Cardiovasc Dis. 2026 Jun;36(6):104625. doi: 10.1016/j.numecd.2026.104625. Epub 2026 Feb 11. | |
| 39354558 |
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Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.
Data will be available after the main paper publication.
Link for design paper (study protocol):
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| Brazilian cardioprotective diet plus 30g/day of mixed nuts | Dietary Supplement | Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts) |
|
| TG | Serum triglycerides (TG), in mg/dL | Changes in TG after 16 weeks |
| VLDL-c | Very low-density lipoprotein cholesterol (VLDL-c), in mg/dL; serum triglycerides, (in mg/dL) divided by 5 will be used to report VLDL-c in mg/dL | Changes in VLDL after 16 weeks |
| NHDL-c | Non-HDL cholesterol (NHDL-c), in md/dL; total cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report NHDL-c in mg/dL | Changes in NHDL-c after 16 weeks |
| TG/HDL-c | TG/HDL-c ratio (TG/HDL-c), in mg/dL; serum triglycerides (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report TG/HDL-c in mg/dL | Changes in TG/HDL-c after 16 weeks |
| Castelli I index | TC/HDL-c ratio, in mg/dL; total cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report Castelli I index in mg/dL | Changes in Castelli I index after 16 weeks |
| Castelli II index | LDL-c/HDL-c ratio, in mg/dL; low-density lipoprotein cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report Castelli II index in mg/dL | Changes in Castelli II index after 16 weeks |
| FG | Fasting glucose (FG), in mg/dL | Changes in FG after 16 weeks |
| INS | Serum insulin (INS), in mU/L | Changes in INS after 16 weeks |
| HbA1C | glycated hemoglobin (HbA1C), in % | Changes in HbA1C after 16 weeks |
| HOMA-IR | Homeostasis model assessment-insulin resistance, defined according to: [FG (in mmol) x INS (in UI/mL) ÷ 22.5] | Changes in HOMA-IR after 16 weeks |
| BW | Body weight, in kg | Changes in BW after 16 weeks |
| BMI | Body mass index (BMI), in kg/m^2; weight (in kg) and height (in meters) will be combined to report BMI in kg/m^2 | Changes in BMI after 16 weeks |
| WC | Waist circumference (WC), in cm | Changes in WC after 16 weeks |
| HC | Hip circumference, in cm | Changes in HC after 16 weeks |
| WHR | Waist-to-hip ratio (WHR); waist circumference (in cm) and hip circumference (in cm) will be combined to report WHR | Changes in WHR after 16 weeks |
| WHt | Waist-to-height ratio (WHt); waist circumference (in cm) and height (in meters) will be combined to report WtH, in cm/m | Changes in WHt after 16 weeks |
| Porto Alegre |
| Rio Grande do Sul |
| 90620-000 |
| Brazil |
| Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR) | Curitiba | Brazil |
| Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG) | Goiânia | Brazil |
| Universidade Federal de Alagoas (UFAL) | Maceió | Brazil |
| Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS) | Porto Alegre | Brazil |
| Instituto Nacional de Cardiologia (INC) | Rio de Janeiro | Brazil |
| Universidade Federal do Maranhão (UFMA) | São Luís | Brazil |
| Hospital do Coração (HCor) | São Paulo | Brazil |
| Derived |
| Bersch-Ferreira AC, Weschenfelder C, Vieira Machado RH, Nakagawa Santos RH, Riley TM, da Silva LR, Miyada DHK, Sady ERR, de Abreu-Silva EO, Laranjeira LN, de Quadros AS, Dos Santos JL, Souza GC, Parahiba SM, Fayh APT, Bezerra DS, Carvalho APPF, Machado MMA, Vasconcelos SML, Santos MVR, de Figueiredo Neto JA, Dias LPP, Zaina Nagano FE, de Almeida CCP, Moreira ASB, de Oliveira RD, Rogero MM, Sampaio GR, da Silva Torres EAF, Weber B, Cavalcanti AB, Marcadenti A. 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. 2024 Oct 1;23(1):118. doi: 10.1186/s12937-024-01020-5. |
| 34470656 | Derived | Marcadenti A, Weber B, Bersch-Ferreira AC, Machado RHV, Torreglosa CR, de Sousa Lara EM, da Silva LR, Santos RHN, Miyada DHK, Sady ERR, Costa RP, Piegas L, de Abreu-Silva EO, de Quadros AS, Weschenfelder C, Dos Santos JL, Souza GC, Parahiba SM, Fayh APT, Bezerra DS, Carvalho APPF, Machado MMA, Vasconcelos SML, Araujo J, de Figueiredo Neto JA, Dias LPP, Nagano FEZ, de Almeida CCP, Moreira ASB, Gapanowicz DP, Purgatto E, Rogero MM, Sampaio GR, da Silva Torres EAF, Duarte GBS, Cavalcanti AB. Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial. Trials. 2021 Sep 1;22(1):582. doi: 10.1186/s13063-021-05494-0. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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