Benecol - Healthcare Professionals

What is plant Stanol Ester

Small amounts of plant stanols occur naturally in many foodstuffs. When added to foods, plant stanols effectively reduce the absorption of all sterols from the digestive tract, hence also decreasing serum cholesterol levels.
Benecol® products contain plant stanol ester and have been developed for people who wish to reduce their serum cholesterol levels through diet.

Effectiveness of PLANT STANOL ESTER

Esterified plant stanols have been proven to reduce cholesterol in a number of randomised, placebo-controlled double-blind clinical trials. Cholesterol-lowering effects have been noted:

• in normo- and hypercholesterolaemic individuals
• in women and men, as well as children
• in patients with coronary heart disease
• in patients with type 1 diabetes
• in patients with type 2 diabetes  
• in conjunction with cholesterol-lowering statin therapy

Additive Effect to Healthy - Low-Saturated Fat, Low-Cholesterol - Diets

The plant stanol ester specific cholesterol-lowering effect is of a similar magnitude irrespective of the fat content or quality of the background diet or if the dietary cholesterol intake is high or low. Importantly, plant stanol ester adds to the effect of other dietary changes.

Additive Effect to Statin Medication

Statins are the most widely used cholesterol-lowering drugs currently available. They reduce serum cholesterol concentrations by inhibiting the synthesis of cholesterol. Since statins and stanols have different cholesterol-lowering mechanisms, they act additively in a clinical treatment. For example, the addition of plant stanol margarine to the diets of heart transplant patients reduced cholesterol levels 22% more than statin did on its own. Subsequently, 70% of the patients were able to reduce their statin intake by adding stanol ester margarine to their diets.

Stanol Dosage

Concerning esterified plant stanols, the combined data of various clinical studies shows that optimum LDL reduction is achieved with an intake of about 2 g/d. Greater quantities do not reduce serum LDL levels much further (1). The minimum amount of plant stanol required to significantly lower cholesterol is approximately 0.8-1.0 g/d. However, most of the studies focused on higher intake levels, about 2-3 g/d of plant stanols in their esterified, fat-soluble forms.

Frequency of Consumption

Most studies on the consumption of stanol assessed the effects of taking two or more doses of stanol a day. However, Plat and Mensink (2) showed that one daily intake of 2.5 g of esterified plant stanols at lunchtime for 4 weeks was as effective in lowering serum LDL-cholesterol concentrations as when the dose was split over three meals.

Dual Effect of PLANT STANOL

Plant stanol reduce both cholesterol and plant sterol levels in serum. This may be of importance since elevated plant sterol concentrations have been identified as an independent risk factor for coronary heart disease (CHD). Two ABC transporters (ABCG5 and ABCG8) play an important role in the regulating the intestinal absorption of plant sterols by resecreting previously absorbed plant sterols from the enterocytes back into the intestinal lumen. Mutations in these transporter proteins lead to a rare congenital disease called sitosterolaemia, which is characterised by:

• severely elevated serum plant sterol concentrations,
• normal to moderately increased serum cholesterol concentrations, and
• a high risk of developing CHD at a very early age.

It was recently shown that polymorphisms in the ABCG5 and ABCG8 genes contribute to modifying serum plant sterol levels in healthy, non-sitosterolaemic individuals. Furthermore, several epidemiological studies have shown that the risk of developing heart disease seems to be increased even at more "normal" plant sterol levels (3-5). Since statins were shown to increase serum plant sterol concentrations (6, 7), patients should probably not be treated with statins alone but with a combination therapy focusing simultaneously on improving the serum lipoprotein profile and lowering serum plant sterol concentrations.

Safety of PLANT STANOL ESTER

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

• safe to use,
• well tolerated, and
• have no adverse effects.

Furthermore, as plant stanols are absorbed minimally, the lack of bioavailability after ingestion of plant stanol ester make adverse systemic effects of plant stanols highly unlikely. Plant stanol ester have been generally recognised as safe (GRAS) in the USA.

They were also evaluated by food authorities in several EU member states before entering the individual markets. Furthermore, European food authorities evaluated the use of stanols and sterols in foods and recommend a daily intake of 1-3 g phytosterols and stanols (8).

As a consequence of the reduced absorption of cholesterol, the absorption of fat-soluble components other than cholesterol, such as vitamins and antioxidants, may also be reduced. Like cholesterol, carotenoids and tocopherols are transported by lipoproteins. Since the number of LDL particles in circulation decreases 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 of randomised, placebo-controlled trials on the effects of plant sterols or stanols on fat-soluble vitamins and antioxidants were summarised in 2003 (1). Significant reductions were only seen in clinical trials for hydrocarbon carotenoids. These reductions are probably caused by reduced absorption and 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 carotenoid and tocopherol levels remained within the normal ranges. Clinical trials also showed that when following the recommended diet, including consumption of vegetables and fruit, carotenoid levels did not decrease (9, 10). Plasma concentrations of retinol (vitamin A), 25-hydroxyvitamin D and vitamin K are unaffected by dietary plant sterols and stanols.

Benecol Food Applications

Benecol products have been developed for people who wish to reduce their serum cholesterol levels through diet. Each Benecol-labelled food contains enough plant stanol esters to lower cholesterol. This effect occurs when the product is consumed on a daily basis at normal dietary levels.
Benecol foods are also good for the heart thanks to their low fat content and a nutritionally desirable fatty acid profile. At their best, Benecol products allow consumers to follow a heart-friendly diet.

The most popular Benecol products are yoghurt drink and spread.

Although, chemically speaking, plant stanol ester is a fat, it can be added to many low-fat foods. Benecol food applications vary from high-fat margarines to dairy and cereal foods in which plant stanol ester is the only source of fat in the product.

Click here for a list of countries and the products available in each one.

Randomised, placebo-controlled trials were conducted for each new Benecol product to ensure that the cholesterol-lowering effect of plant stanol ester is not impaired by the change in product platform.

References:

1. Katan MB et al. Efficacy and Safety of plant Stanols and Sterols in the Management of Blood Cholesterol Levels. Mayo Clin Proc. 2003;78:965-78.
2. Plat J and Mensink RP. Effects on Serum Lipids, Lipoproteins and Fat Soluble Antioxidant Concentrations of Consumption Frequency of Margarines and Shortenings Enriched with plant Stanol Esters. Eur J Clin Nutr. 2000;54:671-76.
3. Glueck et al. Relationships of Serum Plant Sterols (Phytosterols) and Cholesterol in 595 Hypercholesterolemic Subjects, and Familial Aggregation of Phytosterols, Cholesterol, and Premature Coronary Heart Disease in Hyperphytosterolemic Probands and Their First-Degree Relatives. Metabolism. 1991;40:842-48.
4. Sudhop T et al. Serum Plant Sterols as a Potential Risk Factor for Coronary Heart Disease. Metabolism. 2002;51:1519-21.
5. Assmann G et al. Elevation in Plasma Sitosterol Concentration Is Associated with an Increased Risk for Coronary Events in the PROCAM Study. Circulation. 2003;108 (Suppl. IV-730):3300.
6. Miettinen TA et al. Noncholesterol Sterols and Cholesterol Lowering by Long-Term Simvastatin Treatment in Coronary Patients: Relation to Basal Serum Cholestanol. Arterioscler Thromb Vasc Biol. 2000;20:1340-46.
7. Gylling H and Miettinen TA. Baseline Intestinal Absorption and Synthesis of Cholesterol Regulate Its Response to Hypolipidaemic Treatments in Coronary Patients. Atherosclerosis. 2002;160:477-81.
8. European Commission, Scientific Committee on Foods, General View on the Long-Term Effects of the Intake of Elevated Levels of Phytosterols from Multiple Dietary Sources, with Particular Attention to the Effects on α-Carotene, 26 September 2002.
9. Hallikainen MA et al. Effects of Low-Fat Stanol Ester Enriched Margarines on Concentrations of Serum Carotenoids in Subjects with Elevated Serum Cholesterol Concentrations. Eur J Clin Nutr. 1999;53:966-69.
10. Noakes M et al. An Increase in Dietary Carotenoids When Consuming Plant Sterols or Stanols Is Effective in Maintaining Plasma Carotenoid Concentrations. Am J Clin Nutr. 2002;75:79-86.