Key result
BALANCE Program fails to alter plasma apolipoproteins despite reducing total and non-HDL cholesterol.
Why the study?
The study aimed to evaluate the impact of the Brazilian Cardioprotective Nutrition Program (BALANCE Program) on plasma apolipoproteins and lipid biomarkers over three years in individuals undergoing secondary cardiovascular prevention.
Does the BALANCE Program improve plasma levels of apolipoproteins in patients undergoing secondary cardiovascular prevention?
RCT (n=276)
Blinding maintained for statisticians, data managers, and laboratory staff only
1:1 allocation ratio, stratified by study site and performed in blocks
Yes
Does the BALANCE Program improve plasma levels of apolipoproteins in patients undergoing secondary cardiovascular prevention?
An intensive cardioprotective dietary program improved dietary adherence and reduced total cholesterol, but did not significantly alter apolipoprotein profiles in patients with established cardiovascular disease.
Does not support apolipoprotein targeting with BALANCE in secondary prevention; extends evidence on differential dietary lipid effects.
Objective This study aimed to evaluate the impact of the Brazilian Cardioprotective Nutrition Program (BALANCE Program) on the plasma levels of various apolipoproteins (A-I, A-II, B, C-II, C-III, and E) and lipid biomarkers over a three-year follow-up period in individuals undergoing secondary cardiovascular prevention. Subjects and methods This exploratory analysis included 276 patients aged 45 years or older with a history of cardiovascular disease within the preceding decade. Participants were randomly assigned to one of two groups and monitored over three years: the BALANCE Program group (intervention group; n = 123) and the control (conventional nutritional advice; n = 153). Assessments of clinical and lifestyle data, anthropometry, food intake, plasma apolipoproteins, and lipid profiles were conducted at baseline and at the 3-year follow-up. Intervention adherence was measured utilizing the BALANCE dietary index. Results By the end of the follow-up period, adherence was significantly higher in the intervention group (mean difference BALANCE-control [95% CI]: 2.09 points [-0.19; 4.37]), mainly due to increased consumption of fruits, vegetables, legumes, and low-fat dairy products. There were no significant differences in plasma apolipoprotein levels between the groups throughout the study. Nevertheless, significant reductions were observed in the total cholesterol and non-HDL cholesterol levels in the BALANCE group compared to the control group (mean difference intervention-control [95% CI]: -9.95 mg/dL [-18.5; -1.39] and -8.86 mg/dL [-17.53; -0.2], respectively). Conclusion Following three years of intervention, despite higher adherence to the BALANCE Program, there were no significant changes in plasma apolipoprotein concentrations or overall lipid biomarkers.
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Marcadenti et al. (2025) conducted an RCT in Secondary cardiovascular prevention (n=276). Brazilian Cardioprotective Nutrition Program (BALANCE Program) vs. Conventional nutritional advice was evaluated on Plasma levels of various apolipoproteins (A-I, A-II, B, C-II, C-III, and E). The BALANCE Program did not significantly alter plasma apolipoprotein concentrations over 3 years, although it significantly reduced total and non-HDL cholesterol.
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