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Safety assessment of common foods enriched with natural nonesterified plant sterols.
Eur J Clin Nutr. 2009 May; 63(5):684-91.EJ

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 alpha-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 alpha-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.

Authors+Show Affiliations

Department of Health Promotion and Chronic Disease Prevention, Division of Biochemistry, National Public Health Institute, University of Helsinki, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18270526

Citation

Tuomilehto, J, et al. "Safety Assessment of Common Foods Enriched With Natural Nonesterified Plant Sterols." European Journal of Clinical Nutrition, vol. 63, no. 5, 2009, pp. 684-91.
Tuomilehto J, Tikkanen MJ, Högström P, et al. Safety assessment of common foods enriched with natural nonesterified plant sterols. Eur J Clin Nutr. 2009;63(5):684-91.
Tuomilehto, J., Tikkanen, M. J., Högström, P., Keinänen-Kiukaanniemi, S., Piironen, V., Toivo, J., Salonen, J. T., Nyyssönen, K., Stenman, U. H., Alfthan, H., & Karppanen, H. (2009). Safety assessment of common foods enriched with natural nonesterified plant sterols. European Journal of Clinical Nutrition, 63(5), 684-91. https://doi.org/10.1038/ejcn.2008.11
Tuomilehto J, et al. Safety Assessment of Common Foods Enriched With Natural Nonesterified Plant Sterols. Eur J Clin Nutr. 2009;63(5):684-91. PubMed PMID: 18270526.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety assessment of common foods enriched with natural nonesterified plant sterols. AU - Tuomilehto,J, AU - Tikkanen,M J, AU - Högström,P, AU - Keinänen-Kiukaanniemi,S, AU - Piironen,V, AU - Toivo,J, AU - Salonen,J T, AU - Nyyssönen,K, AU - Stenman,U-H, AU - Alfthan,H, AU - Karppanen,H, Y1 - 2008/02/13/ PY - 2008/2/14/pubmed PY - 2009/6/17/medline PY - 2008/2/14/entrez SP - 684 EP - 91 JF - European journal of clinical nutrition JO - Eur J Clin Nutr VL - 63 IS - 5 N2 - 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 alpha-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 alpha-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. SN - 1476-5640 UR - https://www.unboundmedicine.com/medline/citation/18270526/Safety_assessment_of_common_foods_enriched_with_natural_nonesterified_plant_sterols_ L2 - https://doi.org/10.1038/ejcn.2008.11 DB - PRIME DP - Unbound Medicine ER -