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Coronary Artery DiseaseDICA-NUTSNCT03728127

Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

A study testing Brazilian cardioprotective diet and Brazilian cardioprotective diet plus 30g/day of mixed nuts in people with Coronary Artery Disease and Myocardial Infarction, run by Hospital do Coracao at 9 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Brazilian cardioprotective diet and Brazilian cardioprotective diet plus 30g/day of mixed nuts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
9 sitesBrazil
Study dates
3 Jan 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Clinical indication of myocardial revascularization surgery (graf /bypass);
  • HIV positive in treatment/AIDS;
  • Chronic inflammatory diseases;
  • Cancer;
  • Chemical dependency/alcoholism;
  • Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
Show all 12Show fewer
  • Pregnancy or lactation;
  • Wheelchair users without conditions of anthropometric evaluation;
  • Extreme obesity (BMI ≥40kg / m²);
  • Use of dietary supplements;
  • Rejection/allergy to oilseed consumption;
  • Participation in other randomized studies at the time of enrollment.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Brazil9 sites

  • Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR)

    Curitiba

  • Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG)

    Goiânia

  • Universidade Federal de Alagoas (UFAL)

    Maceió

  • Universidade Federal do Rio Grande do Norte

    Natal, Rio Grande do Norte

  • Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90620-000

  • Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS)

    Porto Alegre

  • Instituto Nacional de Cardiologia (INC)

    Rio de Janeiro

  • Universidade Federal do Maranhão (UFMA)

    São Luís

  • Hospital do Coração (HCor)

    São Paulo

Other trials in Brazil

About this study

Official title: Effect of the Brazilian Cardioprotective Diet and Nuts on Cardiometabolic Parameters in Post-acute Myocardial Infarction: a Randomized Clinical Trial (DICA-NUTS Study)

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.

Being tested
Brazilian cardioprotective diet, Brazilian cardioprotective diet plus 30g/day of mixed nuts
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brazilian cardioprotective dietDietary supplement

    Brazilian cardioprotective diet prescription

  • Brazilian cardioprotective diet plus 30g/day of mixed nutsDietary supplement

    Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)

Study groups in NCT03728127
Study groupRoleWhat they receive
DicaBr group and nuts (DCBN)ExperimentalBrazilian cardioprotective diet plus 30g/day of mixed nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)
Receives: Dietary Supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts
DicaBr group (DCB)Active comparatorBrazilian cardioprotective diet
Receives: Dietary Supplement: Brazilian cardioprotective diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL-c

    Low-density lipoprotein cholesterol (LDL-c), in mg/dL: LDL-c will be detected by Martins´mathematical formula

    Measured: Changes in LDL-c after 16 weeks

Secondary outcomes (18)

  1. TC

    Total cholesterol (TC), in mg/dL

    Measured: Changes in TC after 16 weeks

  2. HDL-c

    High-density lipoprotein cholesterol (HDL-c), in mg/dL

    Measured: Changes in HDL-c after 16 weeks

  3. TG

    Serum triglycerides (TG), in mg/dL

    Measured: Changes in TG after 16 weeks

  4. 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

    Measured: Changes in VLDL after 16 weeks

  5. 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

    Measured: Changes in NHDL-c after 16 weeks

  6. 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

    Measured: Changes in TG/HDL-c after 16 weeks

  7. 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

    Measured: Changes in Castelli I index after 16 weeks

  8. 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

    Measured: Changes in Castelli II index after 16 weeks

  9. FG

    Fasting glucose (FG), in mg/dL

    Measured: Changes in FG after 16 weeks

  10. INS

    Serum insulin (INS), in mU/L

    Measured: Changes in INS after 16 weeks

  11. HbA1C

    glycated hemoglobin (HbA1C), in %

    Measured: Changes in HbA1C after 16 weeks

  12. HOMA-IR

    Homeostasis model assessment-insulin resistance, defined according to: [FG (in mmol) x INS (in UI/mL) ÷ 22.5]

    Measured: Changes in HOMA-IR after 16 weeks

  13. BW

    Body weight, in kg

    Measured: Changes in BW after 16 weeks

  14. 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

    Measured: Changes in BMI after 16 weeks

  15. WC

    Waist circumference (WC), in cm

    Measured: Changes in WC after 16 weeks

  16. HC

    Hip circumference, in cm

    Measured: Changes in HC after 16 weeks

  17. WHR

    Waist-to-hip ratio (WHR); waist circumference (in cm) and hip circumference (in cm) will be combined to report WHR

    Measured: Changes in WHR after 16 weeks

  18. WHt

    Waist-to-height ratio (WHt); waist circumference (in cm) and height (in meters) will be combined to report WtH, in cm/m

    Measured: Changes in WHt after 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2018
  2. Study start3 Jan 2019
  3. Primary completion13 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728127
Sponsor's protocol ID
DICA-NUTS
Other IDs
U1111-1259-8105
Acronym
DICA-NUTS
Status last verified
Feb 2022
First submitted
29 Oct 2018
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41856832

  • 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.

    PubMed 39354558

  • 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.

    PubMed 34470656

Questions about this trial

What is this clinical trial studying?

A study testing Brazilian cardioprotective diet and Brazilian cardioprotective diet plus 30g/day of mixed nuts in people with Coronary Artery Disease and Myocardial Infarction, run by Hospital do Coracao at 9 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-c (time frame: Changes in LDL-c after 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728127, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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