Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction (DICA-NUTS)

Hospital do Coracao

Status

Completed

Conditions

Coronary Artery Disease

Myocardial Infarction

Treatments

Dietary Supplement: Brazilian cardioprotective diet

Dietary Supplement: Brazilian cardioprotective diet plus 30g/day of mixed nuts

Study type

Interventional

Funder types

Other

Identifiers

NCT03728127

U1111-1259-8105 (Other Identifier)

DICA-NUTS

Details and patient eligibility

About

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.

Enrollment

488 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.