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Abstract
This randomized, placebo-controlled, crossover trial assessed the lipid-altering efficacy of a dietary supplement (tablet form) providing 1.8 g/day free (non-esterified) plant sterols and stanols versus placebo for 6 weeks as part of a therapeutic lifestyle changes (TLC) diet in 32 men and women with primary hypercholesterolaemia. Mean ± SE baseline (end of a 5-week TLC diet lead-in) lipid concentrations (mmol/l) were total cholesterol (TC), 5.88 ± 0.08; non-high-density lipoprotein cholesterol (non-HDL-C), 4.71 ± 0.09; low-density lipoprotein cholesterol (LDL-C), 4.02 ± 0.08; HDL-C, 1.17 ± 0.06 and triglycerides (TGs), 1.51 ± 0.12. Differences from control in responses (plant sterol/stanol − control) were significant (p < 0.05) for LDL-C ( − 4.9%), non-HDL-C ( − 3.6%) and TC ( − 2.8%). HDL-C and TG responses were not significantly different between treatment conditions. These results indicate that 1.8 g/day free plant sterols/stanols administered in a tablet produced favourable lipoprotein lipid changes in men and women with hypercholesterolaemia.
Acknowledgements
The authors wish to thank Arianne Schild of Provident Clinical Research/Biofortis North America for assistance with statistical analysis and Rachel Hubacher and Nicholas Shera, both formerly with Provident Clinical Research/Biofortis North America, for technical assistance.
Declaration of interest: This trial was funded by Pharmavite, LLC, Northridge, CA, USA. KCM, ALL, MSR and MRD were, at the time this study was conducted, employees of Provident Clinical Research, which has received research grant support and consulting fees from Pharmavite, LLC, the manufacturer of the product studied. BHJ, ES and JRB are employees of Pharmavite, LLC, the manufacturer of the product studied.