The effect of the a regional cardioprotective nutritional program on inflammatory biomarkers and metabolic risk factors in secondary prevention for cardiovascular disease, a randomised trial.

BACKGROUND & AIMS: To evaluate the effect of the Brazilian Cardioprotective Diet Program (BALANCE Program) on inflammatory biomarkers, involved in the pathophysiology of the atherosclerosis, on inflammatory biomarkers, cardiovascular risk factors, and on plasma fatty acids in cardiovascular disease secondary prevention patients.

METHODS

In this substudy of the BALANCE Program randomized clinical trial, a total of 369 patients aged 45 years or older, who have experienced cardiovascular disease in the previous 10 years, were included. These patients were randomized into two groups and followed up for six months: BALANCE Program group and control group (conventional nutrition advice). In the initial and six-month final visits, anthropometry (body weight, height and waist circumference), food intake evaluation by 24-h dietary recall, plasma inflammatory biomarkers (IL-6, IL-8, IL-10, IL-12, tumor necrosis factor-α, adiponectin, and C-reactive protein levels), blood pressure, glycemia, insulinemia, lipid profile, and plasma fatty acids levels were evaluated.

RESULTS

The BALANCE Program group showed increased plasma alpha-linolenic acid levels (P = 0.008), reduction in waist circumference (P = 0.049) and BMI (P = 0.032). No difference was observed among plasma inflammatory biomarkers and clinical data.

CONCLUSION

After six months of follow-up, BALANCE Program led to a significant reduction on BMI and waist circumference in individuals in secondary prevention for cardiovascular disease. Although plasmatic alpha-linolenic acid has increased, there was no impact on plasma inflammatory biomarkers.

CLINICAL TRIAL REGISTRATION

NCT01620398.