Brazilian Cardioprotective Nutritional Program Trial
Brazilian Cardioprotective Nutritional Program Trial
There are no studies exploring the benefits of a diet composed of typical Brazilian food in
 the secondary prevention of cardiovascular diseases. Randomized studies show that the
 Mediterranean diet is beneficial for patients with established cardiovascular disease or in
 risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of
 main references for dietary guidelines for treatment and prevention of CVD in Brazil and the
 world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are
 not widely available, may be expensive or are not part of population eating habits. So, the
 prescription of the Mediterranean diet intervention for cardiovascular disease to the
 Brazilian population may not be feasible, leading to a low adherence. In this context,
 patients with established CVD have a low compliance to nutritional prescription. The BALANCE
 Program, considers 3 concepts: a) A dietary prescription guided by nutritional content
 recommendations from the Brazilian national guidelines; b) A nutritional education program
 based on fun, playful strategies and suggestions of affordable foods; and c) Intensive
 follow-up through one-on-one visits, group sessions, and phone calls. This is the first
 proposal to use these concepts concurrently with the objective to increase adherence of
 secondary prevention patients to the diet proposed by the guidelines. Therefore, The primary
 outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction,
 stroke, myocardial revascularization, amputation for peripheral arterial disease, or
 hospitalization for unstable angina.
The BALANCE Program will investigate the effect of the Program in reducing cardiovascular
 events, such as cardiac arrest, acute myocardial infarction, stroke, myocardial
 revascularization, amputation for peripheral arterial disease, hospitalization for unstable
 angina, or death in patients with established cardiovascular disease. Moreover the aim is to
 evaluate the effect of the dietary program on reducing cardiovascular risk factors, such as
 body mass index, waist circumference, blood pressure, total cholesterol, low density
 lipoprotein (LDL), triglycerides and fasting glucose. Also the objective is to compare the
 dietary patterns after interventions, the effect of the intervention among nutrients and
 energy consumption and, finally, to evaluate the BALANCE Program comprehension.

 The BALANCE Program is a randomized, multicenter, national trial with allocation concealment
 and intention-to-treat analysis. The elegibility criteria is patients aged 45 years or more
 with any evidence of established cardiovascular disease to the BALANCE program or control
 groups. BALANCE Program is composed by 3 concepts: a) a diet that provides 50-60% of energy
 from carbohydrate, 10-15% from protein, 25-35% from total fat, <7% from saturated fatty
 acids, <10% polyunsaturated fatty acids, <20% monounsaturated fatty acids, <1% trans fats,
 <200 mg/day cholesterol, 20-30 g/day fiber, and <2,400 mg/day sodium; b) Nutrition education
 program based on ludic strategies and indication of affordable foods; c) An intense follow up
 by individual and group visits and phone calls. For Control group, generalized advices to
 follow a low fat, low energy, low sodium and low cholesterol diet are given. The primary
 composite outcome is the occurrence of of death (any cause), cardiac arrest, acute myocardial
 infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease
 or hospitalization for unstable angina. Blinded assessors will adjudicate clinical events and
 analysis will follow the intention-to-treat principle. Were enrolled 2534 patients in 35
 sites. Enrollment was open in March 2013 and ended in March 2015 and patients will be
 followed up to 48 months.
Inclusion Criteria:

 -  Any evidence of coronary artery disease (CAD) over the preceding 10 years, as defined
 by any of the following criteria:

 -  defined by previous myocardial infarction,

 -  stable or unstable angina,

 -  history of atherosclerotic stenosis ≥70% of the diameter of any coronary artery
 on conventional or computed tomographic (CT) coronary angiography,

 -  history of angioplasty, stenting, or coronary artery bypass surgery)

 -  Any evidence of stroke in the preceding 10 years

 -  Peripheral Arterial Disease over the preceding 10 years, as defined by any of the
 following criteria:

 -  ankle/arm ratio <0.9 of systolic blood pressure in either leg at rest,
 angiography or Doppler demonstrating >70% stenosis in a cardiac artery,

 -  intermittent claudication,

 -  vascular surgery for atherosclerotic disease,

 -  amputation due to atherosclerotic disease,

 -  aortic aneurysm

 Exclusion Criteria:

 -  Refusal to provide Informed Consent Statement

 -  neurocognitive or psychiatric condition that may hinder collection of reliable
 clinical data (defined at the trial investigator's discretion)

 -  Life expectancy less than 6 months

 -  Pregnancy or lactation

 -  Liver failure with a history of encephalopathy or anasarca

 -  Renal Failure with indication for dialysis

 -  Congestive heart failure

 -  Previous organ transplantation

 -  Wheelchair use

 -  Any restrictions to receiving an oral diet.