Benecol - Healthcare Professionals

Safety of Plant Stanol Ester

Extensive safety studies in humans and animals showed that plant stanol ester is:

• safe to use,
• well tolerated and
• without adverse effects.

Furthermore, plant stanols are absorbed minimally. Hence, because of the lack of bioavailability after the ingestion of plant stanol esters, adverse systemic effects of plant stanols are highly unlikely. Plant stanol ester was deemed generally recognized as safe (GRAS) in the USA.

They were also evaluated by food authorities in several EU member countries before their introduction to the market in each country. Furthermore, food authorities in Europe evaluated the use of stanols and sterols in foods. Their recommendation is that a daily intake should range from 1-3 g phytosterols and stanols (5).

As a consequence of the reduced absorption of cholesterol, the absorption of fat-soluble components other than cholesterol, such as vitamins and antioxidants, might also be reduced. Like cholesterol, carotenoids and tocopherols are transported by lipoproteins. Since the number of LDL particles decreases in circulation after consumption of plant sterols or stanols, plasma concentrations of carotenoids and tocopherols also decrease. This is why these antioxidants are often standardised to plasma lipid concentrations. The results from randomised, placebo-controlled trials on the effects of plant sterols or stanols on fat-soluble vitamins and antioxidants were summarised in 2003 (3). Significant reductions were only seen in clinical trials for hydrocarbon carotenoids. In part, the reduction is likely to be due to reduced absorption, as well as to lower plasma concentrations of the carrier, LDL. After correcting for cholesterol levels, only the reduction in the β-carotene level remained. It is important, however, that the levels of carotenoids and tocopherols still remained within the normal ranges. Furthermore, clinical trials showed that when following dietary recommendations, including consumption of vegetables and fruit, the decrease in carotenoids was prevented (6, 7). Plasma concentrations of retinol (vitamin A), 25-hydroxyvitamin D and vitamin K are unaffected by dietary plant sterols and stanols.

References