OBJECTIVE: As opposed to traditional food based delivery we examined the efficacy of ingesting encapsulated phytosterol esters on indices of lipid health in hypercholesterolemic adults.
METHODS: We performed a randomized, double-blinded, parallel-group, placebo-controlled, clinical intervention examining 54 men and women (20-70 y of age) with a low-density lipoprotein cholesterol (LDL-C) level > /=3.33 mmol/L. Participants were not taking cholesterol-lowering medications. Treatment consisted of ingesting 2.6 g of encapsulated phytosterol esters (n = 25) or a matching placebo (n = 29) for 12 wk.
RESULTS: Total cholesterol (TC) levels at baseline (mean +/- SD) were 6.29 +/- 0.7 mmol/L in the phytosterol group and 6.00 +/- 0.7 mmol/L in the placebo group. Baseline LDL-C levels were 4.27 +/- 0.7 mmol/L in the treatment group and 4.00 +/- 0.8 mmol/L in the placebo group. Analysis of variance and Tukey's least significant difference post hoc analyses revealed a significant within-group reduction in TC (-0.23 +/- 0.4 mmol/L, P < 0.05) and LDL-C (-0.22 +/- 0.5 mmol/L, P < 0.05) for the phytosterol treatment group. Mean reductions in TC and LDL-C were greater than placebo (P < 0.05). Percentages of change from baseline for TC were -3.52% (95% confidence interval -6.44 to -0.40) for phytosterol treatment and 2.64% (95% confidence interval 0.30-5.60) for placebo. Those for LDL-C were -5.00% (95% confidence interval -9.92 to -0.08) for phytosterol and 4.89 (95% confidence interval 0.24-9.5) for placebo. No other significant effects were observed.
CONCLUSION: Encapsulated phytosterol ester ingestion appears to positively modulate LDL-C. Given that the reduction in LDL-C was not as extensive as in food-based trials, future investigations should examine potential timing and dose issues relative to encapsulated delivery.