A well-controlled clinical trial previously demonstrated the efficacy of a novel softgel dietary supplement providing 1.8 g/day esterified
plant sterols and stanols, as part of the National
Cholesterol Education Program Therapeutic Lifestyle Changes diet, to improve the fasting
lipid profile of men and women with primary
hypercholesterolemia (fasting
low-density lipoprotein [
LDL] cholesterol ≥ 130 and <220 mg/dL [≥ 3.37 and <5.70 mmol/L]). The purpose of this randomized, double blind, placebo-controlled crossover study (conducted July 2011 to January 2012) was to support these previous findings in a similar, but independent, sample with a different lead investigator and research site. Repeated measures analysis of covariance was used to compare outcomes for
sterol/stanol and placebo treatment conditions using the baseline value as a covariate. Forty-nine subjects were screened and 30 (8 men and 22 women) were randomized to treatment (all completed the trial). Baseline (mean ± standard error of the mean) plasma
lipid concentrations were: total
cholesterol 236.6 ± 4.2 mg/dL (6.11 ± 0.11 mmol/L),
high-density lipoprotein (
HDL) cholesterol 56.8 ± 3.0 mg/dL (1.47 ± 0.08 mmol/L),
LDL cholesterol 151.6 ± 3.3 mg/dL (3.92 ± 0.09 mmol/L), non-
HDL cholesterol 179.7 ± 4.6 mg/dL (4.64 ± 0.12 mmol/L), and
triglycerides 144.5 ± 14.3 mg/dL (1.63 ± 0.16 mmol/L). Mean placebo-adjusted reductions in plasma
lipid levels were significant (P<0.01) for
LDL cholesterol (-4.3%), non-
HDL cholesterol (-4.1%), and total
cholesterol (-3.5%), but not for
triglycerides or
HDL cholesterol. These results support the efficacy of 1.8 g/day esterified
plant sterols/stanols in softgel capsules, administered as an adjunct to the National
Cholesterol Education Program Therapeutic Lifestyle Changes diet, to augment reductions in atherogenic
lipid levels in individuals with
hypercholesterolemia.