Effect of phytosterol capsule supplementation associated with the National Cholesterol Education Program Step 2 diet on low-density lipoprotein in children and adolescents with dyslipidemia: A double-blind crossover trial

Objective: To evaluate the effect of phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet on LDL-C levels in children and adolescents with dyslipidemia.

Methods: This is a randomized, double-blind, crossover trial conducted with children and adolescents (n = 31; mean ± SD, age 9.0 ± 2.22 years, BMI zscore 1.65 ± 1.47 kg/m²) with dyslipidemia. After a run-in period, the participants were randomly allocated to control or intervention groups. The intervention group received capsules containing 1.5 g/day of phytosterols, and the control group received capsules containing 2 g/day of sunflower oil for 8 weeks. Patients in both groups were instructed to follow the NCEP Step 2 diet during the study. The primary outcome was LDL-C and secondary outcomes were total cholesterol (TC), HDL-C, triglyceride, insulin, blood pressure, and anthropometric measures. Intention-to-treat analyses were performed using the proc mixed procedure in SAS.

Results: The rate of change for LDL-C was not different between intervention and control groups (p=0.30). No significant reduction was also observed for TC (p=0.47), HDL-C (p=0.97), insulin (p=0.27), triglycerides (p=0.38), systolic blood pressure (p=0.11), and diastolic blood pressure (p=0.57) compared to control group. Although we observed a high adherence to the capsule intake (95.7% in phytosterol and 93.8% in the control group), the low adherence to the diet may have contributed to explaining the results.

Conclusion: Daily phytosterol capsules supplementation associated with the NCEP Step 2 diet did not reduce LDL-cholesterol concentrations in children and adolescents with dyslipidemia.