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The phytosterol phenomenon

Despite recent governmental support of statin drugs, manufacturers of plant-derived compounds that naturally lower cholesterol see a bright future. JOYSA WINTER reports on the latest trends, including the combining of sterols with other ingredients to target specific health conditions, and the advent of oils infused with phytosterols

As rates of heart disease and obesity continue to soar worldwide, makers of plant sterols and stanols are optimistic. While scientists laboured for much of the 1990s to find ways to blend these natural cholesterol-lowering compounds, which are hydrophobic, into beverages and other non-oil-based formulas, such formulation challenges are now a thing of the past.

The few hurdles standing in the way of widespread consumer use today include the cumbersome regulatory processes of the European Union, which prohibit sterols from dietary supplements altogether and severely limit their incorporation into food products; the high-powered marketing campaigns of pharmaceutical companies, which in August succeeded in making cholesterol-lowering statins an over-the-counter drug in the UK; and the challenge of educating consumers, who may be more inclined to just ?pop a pill? prescribed by their doctor (even if this pill has side effects) than alter their diets and seek out sterol-fortified food products or supplements.

But sterols manufacturers are rising to these challenges. Cognis Nutrition & Health, one of the leading producers of sterols and sterol esters, sold under the brand name Vegapure, reports its sales have grown steadily since entering the market in 2002. Forbes MediTech, the maker of Reducol, reports sales of $14.16 million in 2004, up from $11.58 million in 2003. The Canadian company forecasts $17-$17.8 million in 2005. And Finnish company Raisio Life Sciences reports sales of its stanol ester product Benecol grew by almost 40 per cent during the first three quarters of 2004 over 2003.

Cargill, the maker of a sterols/sterol esters blend called CoroWise, crossed two major milestones recently. First, its ingredient has appeared in the first sterols-fortified yoghurt available on the American market. Two cups a day of Yoplait Healthy Heart, by General Mills, provides 0.8g of plant sterols — the same amount found in 70 carrots, 44 apples or 26 oranges.

Then, the company received word that Coca-Cola has received approval from UK food authorities to market Europe?s first cholesterol-lowering juice. The company launched an orange juice with Cargill?s CoroWise ingredient under its Minute Maid brand in the US in 2003.

New players are also entering the playing field. In November, US food giant Bunge announced a new alliance with Procter & Gamble and Peter Cremer North America, part of German chemicals firm Cremer, to produce and market a new line of phytosterol ingredients, including sterol esters, free sterols and spray-dried esters. The companies estimate that by 2008, global demand for phytosterols will top 10,000 tonnes, a figure that represents a potential market value of $200-$250 million. In 1999, demand was around 4,000 tonnes.

In short, the future looks promising. ?In Europe, regulations preclude the sale of phytosterols in supplements, but the market potential is quite significant in North America,? says Laura Brennan, Cognis? marketing manager, heart health. ?The recent shift in the guidelines for cholesterol measurement by the US government?s National Cholesterol Education Program means that the number of people who need to manage cholesterol is expected to nearly triple.?

What?s ahead
One of the hot new trends in the phytosterol category is the combining of sterols with other health-promoting ingredients, to target specific medical conditions.

?Combining stanols or sterols with another beneficial ingredient is definitely a coming trend,? says Anu Hopia at Raisio Life Sciences. ?In research literature, this has been discussed and studied actively for some time now. Among the combinations people have studied are sterols with soy protein and soluble fibre for heart health.? Masterfoods USA, a division of Mars Inc, has introduced CocoaVia Bars, which contain at least 100mg of cocoa flavanols and 1.5g of sterol esters per bar. Additionally, each bar contains 1g of fibre, and is a good source of calcium and a source of vitamins C, E, B6 and B12, and folic acid. Sold only in the US via the Internet, the company recommends consuming two of the 80-calorie bars per day.

?With the Mars scientific research on cocoa flavanols focusing on the potential heart-healthy benefits, adding soy sterol esters provided another channel to impact heart health,? says Marlene Machut, of the Health, Science and Nutrition Communications division at Masterfoods USA. ?The flavanols appear to impact blood flow and healthy blood vessels, while the sterols induce an LDL cholesterol reduction.? The CholestSafe dietary supplement manufactured by FoodScience of Vermont combines red yeast rice (Monascus porporeus), policosanols, co-Q10, chromium polynicotinate, EPA, artichoke leaf extract and guggul lipids with 166.5mg of soy-derived phytosterols to support healthy cholesterol levels.

The ModuChol supplement by Canada-based Essential Phytosterolins Inc, a subsidiary of South African Essential Sterolin Products, contains 0.65g of sterol esters per capsule. Other products in the line include Moducare, advertised as a clinically tested immune health booster, which contains 20mg of sterols and 0.2mg of sterolins. The company?s latest launch, in spring of 2004, called ModuProst, pairs its Harzol blend of sterols and sterolins with saw palmetto extract, nettles, lycopene and green tea as a supplement for prostate health.

SourceOne Global Partners is so confident in the market potential of sterol fortification, it already has a patent application pending for the combination of its antioxidant and anti-inflammatory ingredient Sytrinol, with its non-GMO soy-derived sterols ingredient SterolSource, which is currently sold in supplements. This, despite the fact the results from its double-blind, placebo-controlled study on Sytrinol-SterolSource combining won?t be concluded until this spring.

The theory behind this combination is to target cholesterol levels from both of its sources: food intake and production in the liver. ?Plant sterols block cholesterol absorption from the foods that are consumed, but ingested cholesterol has a minor effect on overall lipid profiles, compared to cholesterol produced in the body,? explains Richard Staack, PhD, vice president of business development, technology and science. ?More than 75 per cent of cholesterol is the result of the liver?s imbalanced production of cholesterol, where sterols have no impact. But Sytrinol has been proven to work at the hepatic level.?

Finally, America?s third-largest food company, General Mills, has jumped on board by licensing MultiBene ingredient from Finland?s MultiBene Group. The company expects to be marketing foods made with the ingredient — which combines plant sterols with calcium, magnesium and potassium — by mid-2005. After four years, it finally cleared the EU?s Novel Foods approval process in March 2004; the initial markets for MultiBene-fortified yoghurts, cereals, soy-based drinks and cereal bars include the US, Canada and Mexico. Published clinical trials show benefits in bone health and blood pressure reduction, with yoghurts, breads and meat products made with MultiBene lowering serum cholesterol by 12-13 per cent.

This new trend toward blends, however, doesn?t mean straight-sterol supplementation is going out of vogue.

?Cognis is seeing more blends, but our focus remains on sterols alone, based on the strong science regarding their ability to reduce cholesterol,? Brennan says. ?As we work with our customers in identifying ingredients for heart health, for example, the fundamental question is: ?What clinical science is there to support this product, and what claims can be made???

?In the food industry, sterol blends are not as popular in large part because the health message is so powerful on its own,? adds Franz Timmermann, PhD, Cognis? global market segment manager, functional foods. ?Blends of sterols and other ingredients would need to be clinically proven before being introduced into foods and beverages.?

Hurdles to cross
To date, many of these innovative new product launches are restricted to the US because in Europe, sterol esters have only been approved for milk-based products, cheeses, yoghurts, soy drinks, fat spreads and dressings under Novel Foods regulations.

?This restricts any new product categories quite effectively,? says Leena Morander, product development manager at Teriaka. ?Chocolates, chews or pastilles could be an easy way to carry food without the need of refrigeration — we have developed a nice chocolate with Diminicol ? but in Europe there is no chance to market it.?

Forbes Medi-Tech has also been anxiously waiting for the European market to open up. ?We have the technology to incorporate sterols into a wide variety of food and beverage matrices,? explains Darren Seed, manager of investor relations. ?We are excited about the upcoming market opportunities in Europe but have been awaiting further regulatory approvals.?

In March, those approvals finally came, when the company received an opinion of substantial equivalence from European regulatory authorities for seven other food categories: yellow fat spreads (margarines), fermented milk-type products, soy drinks, low-fat cheese-type products, yoghurt-type products, spicy sauces and salad dressings. ?Our sales opportunities have increased significantly with the approval of Reducol in these key food groups,? says President and CEO Charles Butt.

Forbes was ready to move when this news came, as it recently completed an expansion of its Texas manufacturing facility, increasing its annual capacity by 50 per cent to 1,500 metric tonnes.

Opportunities with oils
Another avenue of innovation is the addition of phytosterols into oils. Japanese firm the Kao Corporation has created a cooking oil made from soybeans and canola that has been processed to include higher concentrations of the naturally occurring component called diacylglycerol (DAG) — at 80 per cent. (A majority of the DAG, 70 per cent, appears in the (1,3) form, which, studies show, is less likely to be stored as body fat.) This specialised oil is sold in the US under the Enova brand name, with partner ADM. Kao then blended this oil with four per cent plant sterols, sold under the Econa brand, which is currently on the market in Japan. As the phytosterols are fully blended with the DAG, Econa is a clear, transparent oil.

A Kao study, reported at the American Heart Association?s scientific sessions in November, showed that the simultaneous use of the drug pravastatin (10mg/day) with the use of phytosterol/DAG oil in place of ordinary cooking oil at home for 12 weeks lowered total and LDL cholesterol levels five per cent on average from baseline values.

One company specializing in such sterol/DAG fortification is Israel-based Enzymotec. The company?s MultOil ingredient combines 25 per cent phytosterol-esters and 15 per cent DAG through a unique trans-esterification technology. MultOil is designed for use either as a substitute to cooking oil or as an ingredient in foods, such as spreads, salad dressings or mayonnaise. It can also be used in liquid and semi-liquid forms. MultOil has also been used in the company?s new phosphatidylserine (PS)-based product line, which includes HeartPS and OmegaPS. These products are available in either fluid or waxy forms for utilization in dietary supplements and functional foods.

New Zealand?s Olivado has created an avocado extract sold as an oil and in 500mg capsules. Olivado Avocado Oil can be used in cooking up to 255oC, or as a cold dressing. New Zealand avocados have among the highest beta-sitosterol levels in the world — up to 950mg per 100g content compared to 750mg for avocados grown elsewhere. By comparison, olive oil has only 250mg.

Washington-based Barlean?s sells an Omega Man Oil, which combines flax oil, pumpkin seed oil, lignans, and phospholipid and phytosterol complexes. The oil is marketed as a supplement for heart and sexual health, athletic performance and the development of lean muscle mass. Each 1tbsp serving contains 150mg of phytosterols and 2660mg of flax particulates. It is also sold in capsules.

Fighting pharma
One of the challenges remaining today is how to educate consumers — particularly in light of recent government actions supporting pharmaceuticals.

In May 2001, The National Cholesterol Education Program urged that the number of Americans taking prescription cholesterol-lowering drugs be increased to 36 million from 13 million. And in August 2004, the UK became the first country in the world to make a statin drug available over the counter, without a prescription. A month supply of Zocor Heart-Pro (simvastatin) costs about $24.

In Europe, statins have not been challenged. Some doctors have expressed their doubts about the effects of sterol-fortified foods
Teriaka?s Morander says this action mirrors larger sentiments in Europe. ?In Europe, statins have not been challenged,? she says. ?They have been used as an effective medical way of lowering cholesterol. In Finland, some doctors have expressed their doubts about the effects of sterol-fortified foods.?

Statins are not without their risks, however. Beatrice Golomb, MD, PhD, an associate professor of medicine at the University of California-San Diego who has studied statins since 1999, notes that some evidence suggests that up to 20 per cent of patients taking statins encounter some type of side effect. Muscle weakness and fatigue are the most common symptoms, with cognitive symptoms being a close second. One possible reason for such reactions is that in addition to lowering cholesterol, statins decrease levels of the antioxidant co-Q10, which is vital to energy production in the body.

Greg Dodson, product manager at ADM, the maker of CardioAid sterols and sterol esters blend, points to a 2003 Mayo Clinic study that concluded that the addition of sterols to the diet is preferable to increasing statin dose. ?Both statin (drugs) and sterols address heart health by targeting cholesterol, but consumers are not able to recognise sterols with heart health at this time,? Dodson says. ?The next frontier will be fortifying foods that are perceived to be healthy; it has been hard for consumers to grasp the concept of eating foods high in fat to benefit the heart.?

At Cognis, marketing efforts are targeting both consumers and physicians. ?We are working on consumer and physician education programs with both our foods and dietary supplements customers,? Timmermann says. ?In Europe, one of the largest spread producers closed an agreement in the Netherlands with the leading health insurance company. People under the program who consume the cholesterol-reducing margarine will receive an annual reduction of 40E for health insurance.?

Still, these recommendations open the door for phytosterols, many in the industry say. ?Sterols consumption in the US falls far below the daily 1.3g needed to significantly lower blood cholesterol levels because few of us eat the recommended five daily servings of sterol-rich vegetables and fruits,? Cognis? Brennan says. ?Dietary supplements can help close this dietary gap. They are also a safe, natural alternative for those with low to moderate cholesterol levels.?

A study published in 2003 in the Journal of the American Medical Association showed that a low-fat diet supplemented with sterol esters and fibre may lower cholesterol as much as statins. After four weeks, the diet led to a 28.6 per cent decrease in the ?bad? low-density lipoprotein (LDL) form of cholesterol. Those taking statins had a 30.9 per cent reduction.

?What this means is that supplementation of sterols may be an option in lowering cholesterol for the large population who find it difficult to follow a low-fat diet or for those who prefer not to take cholesterol-lowering medications,? Brennan says.

Chocolates — for the heart
Chocolates may prove to be a fertile ground for incorporating phytosterols into the diet. This is because they can be substituted for some of the ?bad? fats normally found in chocolate, which helps preserve taste while also adding a heart-health benefit.

McNeil Nutritionals, a Johnson & Johnson company, recently expanded its line of cholesterol-lowering products into dietary supplement chews, called Benecol Smart Chews, which contain 0.85g of stanol esters per chew. Containing Raisio?s stanol ester ingredient Benecol, the chews are sold in both chocolate and caramel flavours. Masterfoods USA?s recently launched CocoaVia Bars, which pair 1.5g of sterol esters with cocoa flavanols.

Canadian-based Forbes Medi-Tech is also eager to jump on the chocolate bandwagon. ?We have formulated chocolate with sterols and are focusing on finding the right partner for a product in the US market,? says Darren Seed, manager of investor relations.

In 2002, researchers at the University Medical Centre Nijmegen, the Netherlands, conducted a randomised, double-blind, placebo-controlled trial on the effects of dietary chocolates enriched with a tall oil-derived phytosterol-phytostanol mixture, containing 18 per cent (w/w) sitostanol, compared with placebo dietary chocolates, in 70 subjects with primary hypercholesterolaemia.

Consumption of phytosterol-enriched chocolates significantly increased plasma lathosterol concentration (+20.7 per cent), reflecting an increased endogenous cholesterol synthesis in response to phytosterol-induced decreased intestinal cholesterol absorption. Furthermore, the enriched chocolates significantly increased both plasma sitosterol (+95.8 per cent) and campesterol (+64.1 per cent) levels, compared with the placebo.

The researchers concluded that chocolate enriched with phytosterols is effective in lowering blood total and LDL-cholesterol levels, and thus may reduce the risk of CHD.


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