Examination of encapsulated phytosterol ester supplementation on lipid indices associated with cardiovascular disease

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.