Post-launch monitoring supports safety of phytosterol/stanols

By Stephen Daniells

- Last updated on GMT

Related tags: Sterol

Using phytosterol and stanol enriched margarines in everyday life
stabilises cholesterol levels in a free-living population, and
concerns over adverse effects seem unfounded with lower than
recommended intakes being observed.

The study, carried out by the Dutch National Institute for Public Health and the Environment and published in the Journal of Nutrition​, justifies the importance of post-monitoring of functional foods to confirm their efficacy and safety in free-living populations. "The consumption of products enriched with plant sterol or stanol esters lowers serum total and LDL-cholesterol concentrations, thereby most likely reducing the risk of coronary heart disease,"​ wrote lead author Heidi Fransen. "However, using plant sterol (not plant stanol) enriched products elevates serum plant sterol concentrations in humans. This may be unwanted because the health effects of elevated serum plant sterol concentrations are still controversial,"​ she added. Numerous clinical trials carried out in controlled settings led researchers to report that daily consumption of 1.5 to 3 grams of phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease. The new study used data from the Dutch Doetinchem cohort study. Over 4500 subjects were examined initially between 1994 and 1998 and then again five years later (1999 to 2003). Sixty-seven people were found to be regular plant sterol-enriched margarine consumers, and 13 people were consumers of plant stanol-enriched margarines. These subjects were matched with 81 non-consumers. Blood samples were taken to evaluate the serum values of plant sterols or stanols. Fransen and co-workers report that the average intake of plant sterols was 1.1 grams per day, while the average intake of plant stanols was 0.6 grams per day, both of which are significantly lower than the two grams per day recommended intake. Among plant sterol users, blood levels of the plant sterols sitosterol and campesterol increased by 22 and 103 per cent, respectively. Among plant stanol users blood levels of sitostanol and campestanol rose by 197 and 196 per cent, respectively. "To our knowledge, these data are the first to show changes in serum cholesterol, plant sterol, and plant stanol concentrations after (long-term) consumption of plant sterol and stanol enriched margarines in a free-living population in a non-experimental setting,"​ said the researchers. "Whether the increased serum sterol concentrations result in adverse side effects needs to be investigated in future post-launch monitoring studies." Some concerns have been raised that plant serum sterols might be considered as markers for atherosclerosis, however, the lower than recommended daily intake appears to show that the concern raised by certain EU Member States regarding over consumption of phytosterols/-stanols seem unfounded. "Data from these monitoring studies can be used in future risk-benefit analyses of plant sterol or stanol ester-enriched to assess their overall effect in the population,"​ concluded the researchers. Source: Journal of Nutrition​ May 2007, Volume 137, Pages 1301-1306 "Customary Use of Plant Sterol and Plant Stanol Enriched Margarine Is Associated with Changes in Serum Plant Sterol and Stanol Concentrations in Humans"​ Authors: H.P. Fransen, N. de Jong, M. Wolfs, H. Verhagen, W.M.M. Verschuren, D. Lutjohann, K. von Bergmann, J. Plat, and R.P. Mensink

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