3.1. Efficacy Analysis
A total of 94 volunteers was screened, and 50 subjects underwent randomization from October 2021 through April 2022. Forty-nine enrolled subjects successfully completed the trial according to the study design (The mean compliance with the treatment was 94 ± 2% in the active treated group and 90 ± 3% in the placebo group.The final distribution by sex did not show any significant differences between groups (The pre-run-in and post-run-in characteristics of the enrolled subjects are summarized in The study groups were adequately matched for anthropometric, hemodynamic, and laboratory parameters at baseline (At the end of the trial, no significant change was recorded after both treatments as regards anthropometric and hemodynamic variables (No significant change was observed during the placebo-controlled phase (Dietary supplementation with phytosterols was associated with significant improvement in plasma levels of TC, LDL-C, and Apo B-100 compared to baseline. The changes in TC (Cohen’s d = 0.04) and LDL-C (Cohen’s d = 0.04) were also significant compared to placebo (Sex, BMI, and Apo B-100 were not associated with the effect size.