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Safety assessment of common foods enriched with natural nonesterified plant sterols

European Journal of Clinical Nutrition volume 63, pages 684–691 (2009)Cite this article

Abstract

Background/Objectives: To assess safety during a diet based on low-fat foods enriched with nonesterified wood-derived plant sterols and mineral nutrients related to serum phytosterol, sex hormone and fat-soluble vitamin metabolism.

Subjects/Methods: Seventy-one study participants (52 women, 19 men) with mild-to-moderate hypercholesterolemia completed the double-blind, placebo-controlled feeding trial lasting for 15 weeks. The subjects were randomly allocated to the sterol group receiving food items enriched with mineral nutrients as well as with a total of 1.25, 2.5 and 5.0 g per day of plant sterols during the first, second and third 5-week periods, respectively, or to the placebo group receiving similar food items without plant sterols. This outpatient clinical trial with free-living subjects was carried out at two hospital clinics.

Results: Two significant findings were observed. Serum sitosterol concentrations increased from 2.84 to 5.35 mg l−1 (P<0.004 vs placebo) but those of serum total plant sterols did not because of compensatory changes in other phytosterols. The highest plant sterol levels did not exceed 0.6% of total serum sterols. Serum α-tocopherol concentrations decreased in the sterol group by 10% (P<0.0002), but the between-group difference disappeared after adjusting for the change in the carrier (LDL cholesterol).

Conclusions: Fifteen-week consumption of natural nonesterified plant sterol-enriched food does not cause any serious adverse effects during such a period. However, serum α-tocopherol levels were somewhat reduced in the sterol group suggesting that long-term effects of plant sterols on serum fat-soluble vitamin concentrations should be further explored, especially in relation to very low-fat diets.

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Acknowledgements

This study was partly supported by TEKES, Finland. We are grateful for the assistance of Pirjo Härkönen, RN, Eija Lahdensuo, RN, and Marjo Mannelin, MSc, for their contribution in this study.

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Authors and Affiliations

  1. Department of Health Promotion and Chronic Disease Prevention, Division of Biochemistry, National Public Health Institute, University of Helsinki, Finland

    J Tuomilehto & P Högström

  2. Department of Public Health, University of Helsinki, Finland

    J Tuomilehto

  3. South Ostrobothnia Central Hospital, Seinäjoki, Finland

    J Tuomilehto

  4. Department of Medicine, Division of Cardiology, Helsinki University Central Hospital and Biomedicum, Helsinki, Finland

    M J Tikkanen

  5. Department of Public Health Science and General Practice, Oulu University Hospital, Oulu, Finland

    S Keinänen-Kiukaanniemi

  6. Oulu Deaconess Institute, Oulu, Finland

    S Keinänen-Kiukaanniemi

  7. Department of Applied Food Chemistry and Microbiology, University of Helsinki, Finland

    V Piironen & J Toivo

  8. Department of Public Health and Clinical Nutrition, University of Kuopio, Kuopio, Finland

    J T Salonen & K Nyyssönen

  9. Department of Clinical Chemistry, Helsinki University Central Hospital, Finland

    U-H Stenman & H Alfthan

  10. Department of Pharmacology and Toxicology, University of Helsinki, Finland

    H Karppanen

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  1. J Tuomilehto
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  6. J Toivo
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  7. J T Salonen
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  8. K Nyyssönen
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  10. H Alfthan
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  11. H Karppanen
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Corresponding author

Correspondence to M J Tikkanen.

Additional information

Guarantor: MJ Tikkanen.

Contributors: JT was responsible for supervision and planning of the study and participated in writing the article, MJT for interpretation of the results and writing the article, PH for coordination of the study and statistical analysis of data. SK-K coordinated the study at the Oulu centre, VP and JT developed the quantitative method and performed the measurement of plant sterols. JTS and KN determined the concentrations of fat-soluble vitamins. U-HS and HA carried out the hormone determinations, and HK was the inventor of the plant sterol preparation and responsible for planning and designing the study. SK-K, VP, JT, JTS, KN, U-HS, HA and HK helped in finalizing the article.

Duality of interest

Dr Heikki Karppanen is the main inventor of the wood sterol-mineral salt concept, which has been patented in several countries. If sold, he may receive patent-based royalties.

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Tuomilehto, J., Tikkanen, M., Högström, P. et al. Safety assessment of common foods enriched with natural nonesterified plant sterols. Eur J Clin Nutr 63, 684–691 (2009). https://doi.org/10.1038/ejcn.2008.11

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