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Safety of long-term consumption of plant sterol esters-enriched spread

European Journal of Clinical Nutrition volume 57, pages 681–692 (2003)Cite this article

Abstract

Objective: To evaluate both efficacy and safety in humans of long-term consumption of spreads containing plant sterol esters.

Design: Randomized double-blind placebo-controlled parallel trial.

Subjects: Hundred and eighty-five healthy volunteers (35–64 y).

Interventions: Volunteers daily consumed 20 g spread enriched with 1.6 g plant sterols as fatty acid esters or a control spread for 1 y. They continued their habitual diet and lifestyle. Outcome measures included efficacy markers such as total and LDL-cholesterol, a large range of safety parameters, and reporting of adverse events.

Results: Consumption of the plant sterol ester-enriched spread consistently lowered total and LDL cholesterol during the 1 y period on average by 4 and 6%, respectively (0.01<P<0.05). Plant sterols intake did on average not result in a lower carotenoid concentration (when expressed per LDL-cholesterol) after 52 weeks (P>0.05). However, carotenoid concentrations changed over time. Plant sterols intake reduced lipid adjusted α- and β-carotene-concentrations by only 15–25% after 1 y, relative to control. Lipid-adjusted fat-soluble vitamin concentrations remained unchanged. Plant sterol concentrations in serum were increased from 2.76 to 5.31 (µmol/mmol total cholesterol) for campesterol (P<0.0001) and from 1.86 to 2.47 (µmol/mmol total cholesterol) for β-sitosterol (P<0.0001). The increase in total plant sterol concentration in red blood cells (5.29–9.62 µg/g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, β-estradiol and progesterone) as well as all clinical chemical and hematological parameters measured were unaffected. Adverse events reported were not different between subjects consuming control spread and subjects consuming plant sterol esters-enriched spread.

Conclusions: Consumption of a plant sterol esters-enriched spread is an effective way to consistently lower blood cholesterol concentrations and is safe to use over a long period of time.

Sponsorship: Unilever.

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Acknowledgements

We thank all those involved in the conduct of the study, particularly R Buytenhek, J Catsburg, AJ de Vries, MR Hardeman, and WHJ Vaes for analytical support; K Povey for production of the spreads; and JM Leezer-de Hoog, FW Sieling, I van den Assum-Ziel and WAA Klöpping-Ketelaars, for their effort during the clinical part of the study. We also thank the volunteers for their enthusiastic participation.

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Authors and Affiliations

  1. Department of Nutritional Physiology, TNO Nutrition and Food Research, Zeist, The Netherlands

    H F J Hendriks & E J Brink

  2. Unilever Bestfoods North America, Englewood Cliffs, 07632, NJ, USA

    G W Meijer

  3. Department of Lipids and Atherosclerosis, TNO Prevention and Health, Gaubius Laboratory, Leiden, The Netherlands

    H M G Princen

  4. Unilever Health Institute, Vlaardingen, The Netherlands

    F Y Ntanios

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  1. H F J Hendriks
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Contributions

Guarantor: HFJ Hendriks.

Contributors: HFJH and EJB were responsible for the design, the execution, analysis and writing up of the paper. GWM was responsible for the design, execution and writing up of the paper. HGMP was responsible for the execution and writing up of the paper. FYN was responsible for the execution, analysis and writing up of the paper. HFJ wrote the manuscript, and all contributors approved the manuscript.

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Correspondence to H F J Hendriks.

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Hendriks, H., Brink, E., Meijer, G. et al. Safety of long-term consumption of plant sterol esters-enriched spread. Eur J Clin Nutr 57, 681–692 (2003). https://doi.org/10.1038/sj.ejcn.1601598

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