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Nutrition and Disease

Continuous Dose-Response Relationship of the LDL-Cholesterol–Lowering Effect of Phytosterol Intake^1,2

³ Unilever R&D, 3130 AC Vlaardingen, The Netherlands ⁴ Division of Human Nutrition, Wageningen University, 6700 EV Wageningen, The Netherlands

Phytosterols (plant sterols and stanols) are well known for their LDL-cholesterol (LDL-C)–lowering effect. A meta-analysis of randomized controlled trials in adults was performed to establish a continuous dose-response relationship that would allow predicting the LDL-C–lowering efficacy of different phytosterol doses. Eighty-four trials including 141 trial arms were included. A nonlinear equation comprising 2 parameters (the maximal LDL-C lowering and an incremental dose step) was used to describe the dose-response curve. The overall pooled absolute (mmol/L) and relative (%) LDL-C–lowering effects of phytosterols were also assessed with a random effects model. The pooled LDL-C reduction was 0.34 mmol/L (95% CI: –0.36, –0.31) or 8.8% (95% CI: –9.4, –8.3) for a mean daily dose of 2.15 g phytosterols. The impacts of subject baseline characteristics, food formats, type of phytosterols, and study quality on the continuous dose-response curve were determined by regression or subgroup analyses. Higher baseline LDL-C concentrations resulted in greater absolute LDL-C reductions. No significant differences were found between dose-response curves established for plant sterols vs. stanols, fat-based vs. nonfat-based food formats and dairy vs. nondairy foods. A larger effect was observed with solid foods than with liquid foods only at high phytosterol doses (>2 g/d). There was a strong tendency (P = 0.054) towards a slightly lower efficacy of single vs. multiple daily intakes of phytosterols. In conclusion, the dose-dependent LDL-C–lowering efficacy of phytosterols incorporated in various food formats was confirmed and equations of the continuous relationship were established to predict the effect of a given phytosterol dose. Further investigations are warranted to investigate the impact of solid vs. liquid food formats and frequency of intake on phytosterol efficacy.

^* To whom correspondence should be addressed. E-mail: isabelle.demonty{at}unilever.com.

Manuscript received 24 June 2008. Initial review completed 22 July 2008. Revision accepted 18 November 2008.