Clinical trial NCT03728127: Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 488
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria: Patients ≥ 40 years with previous AMI (60 to 180 days).

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: LDL-c
timeFrame: Changes in LDL-c after 16 weeks
Secondary outcomes:
measure: TC
timeFrame: Changes in TC after 16 weeks
measure: HDL-c
timeFrame: Changes in HDL-c after 16 weeks
measure: TG
timeFrame: Changes in TG after 16 weeks
measure: VLDL-c
timeFrame: Changes in VLDL after 16 weeks
measure: NHDL-c
timeFrame: Changes in NHDL-c after 16 weeks
measure: TG/HDL-c
timeFrame: Changes in TG/HDL-c after 16 weeks
measure: Castelli I index
timeFrame: Changes in Castelli I index after 16 weeks
measure: Castelli II index
timeFrame: Changes in Castelli II index after 16 weeks
measure: FG
timeFrame: Changes in FG after 16 weeks
measure: INS
timeFrame: Changes in INS after 16 weeks
measure: HbA1C
timeFrame: Changes in HbA1C after 16 weeks
measure: HOMA-IR
timeFrame: Changes in HOMA-IR after 16 weeks
measure: BW
timeFrame: Changes in BW after 16 weeks
measure: BMI
timeFrame: Changes in BMI after 16 weeks
measure: WC
timeFrame: Changes in WC after 16 weeks
measure: HC
timeFrame: Changes in HC after 16 weeks
measure: WHR
timeFrame: Changes in WHR after 16 weeks
measure: WHt
timeFrame: Changes in WHt after 16 weeks
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul
state: Rio Grande Do Sul
city: Curitiba
country: Brazil
facility: Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR)
city: Goiânia
country: Brazil
facility: Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG)
city: Maceió
country: Brazil
facility: Universidade Federal de Alagoas (UFAL)
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS)
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia (INC)
city: São Luís
country: Brazil
facility: Universidade Federal do Maranhão (UFMA)
city: São Paulo
country: Brazil
facility: Hospital do Coração (HCor)
Study officials:
affiliation: Hospital do Coracao
name: Aline Marcadenti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Alexandre Cavalcanti, PhD
role: STUDY_DIRECTOR
affiliation: Hospital do Coracao
name: Bernardete Weber, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Angela Bersh-Ferreira, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Enilda Lara, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Rachel Machado, MSc
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Lucas Ribeiro, RD
role: STUDY_CHAIR
References:
citation: 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.