Natural Foods Merchandiser

Moving Beyond Margarine

Can you get the benefits of fruits and vegetables from fortified margarine and salad dressing? To some degree, the answer is yes. You've most likely already seen sterol-containing bread spreads, but expect to see fortified yogurts, milk, orange juice and more soon, because they can lower cholesterol. There's enough proof, in fact, that the U.S. Food and Drug Administration is finalizing a health claim that would allow manufacturers to state a connection between reduced heart-disease risk and sterol consumption.

"The sterols or stanols are really the active component in the functional foods," says Phil Harvey, Ph.D., director of science and quality assurance and chief science officer of the National Nutritional Foods Association in Newport Beach, Calif. "Those active ingredients have been shown to have benefits with cholesterol."

Sterols occur naturally in plants and animals. Cholesterol is a sterol found in animals; plant-derived sterols are called phytosterols. The difference between sterols and stanols is that stanols are saturated, meaning their chemical bonds are slightly different, though the terms are sometimes used interchangeably. Phytosterols, because of their molecular similarity to cholesterol, interfere with cholesterol absorption in the gut by competing for the intestinal spaces where cholesterol is transferred to the bloodstream, according to work published in 2000 in the British Medical Journal. When cholesterol is blocked in this way, it is excreted rather than absorbed, resulting in reduced serum cholesterol.

Science Of Sterols
Results of dozens of U.S. and European studies show that consuming 2 to 3 grams of plant-derived sterols per day can lower LDL cholesterol (the so-called bad cholesterol) by about 15 percent and total cholesterol by about 10 percent. In a 1999 review of 16 published human studies, significant sterol-related reductions were reported in 15. The review, published in the American Journal of Medicine, included 590 subjects who, on average, reduced their total cholesterol by 10 percent and their LDL cholesterol by 13 percent. In a British Medical Journal report in 2000, results of a meta-analysis showed phytosterols lower LDL cholesterol, though the effects differ depending on the dose. HDL cholesterol and triglycerides were not affected. In another study, researchers determined a maximum effect on LDL cholesterol to be 14 percent when sterol intake was between 2 and 2.5 grams per day. These effects did not depend on dietary cholesterol intake or cholesterol-lowering medications, according to research published in 2000 in the Journal of Nutrition.

Scientists have also shown that margarine with sterols improves LDL levels and reduces the need for statin drugs in patients with high cholesterol. In the September 2003 issue of the Journal of Heart and Lung Transplantation, researchers reported that they'd treated 17 stable cardiac-transplant patients (16 were on statin therapy) with sterol-containing margarine. Those eating the margarine lowered their total cholesterol by 17 percent and their LDL cholesterol by 22 percent. Twelve of the 17 patients lowered their cholesterol sufficiently to have their statin doses reduced. Eight of those 12 maintained the lowered LDL levels for six weeks.

Some researchers suggest that a strict diet containing plant sterols is as effective as cholesterol-lowering drugs. In the July 2003 issue of the Journal of the American Medical Association, researchers involved 46 adults in a randomized, controlled trial to determine whether a diet low in saturated fats and rich in plant sterols and fiber could reduce cholesterol levels as well as the commonly prescribed lovastatin. After a month, those on the low-fat diet with added sterols and fiber lowered their LDL cholesterol by 28.6 percent; those taking the statin drug had a 30.9 percent reduction. The researchers concluded, "In this study, diversifying cholesterol-lowering components in the same dietary portfolio increased the effectiveness of diet as a treatment" for high cholesterol.

Health Claim
Results of these and other trials prompted the FDA to issue an interim final health rule in 2000, allowing the following claim: "A diet low in saturated fat and cholesterol and including two servings of foods containing plant sterol or stanol esters—supplying at least 1.3 grams plant sterols or 3.4 grams plant stanol esters—may reduce the risk of heart disease." This applied initially to two companies that had filed the initial petition, and only for spreads and salad dressings. But earlier this year, the FDA agreed to allow a wider range of companies making other phytosterol-containing foods to use the claim.

"We really don't anticipate the need for the health claim to be finalized at this point," says Barbara Bentson, director of regulatory and scientific affairs at Minneapolis-based Cargill Health & Food Technologies, a sterol supplier. The FDA's expansion of the rule in February, Bentson says, "essentially allows marketers to introduce products with sterols as long as the food application they're going out in is GRAS [Generally Regarded As Safe, a federal designation] and meets the criteria for the health claim."

To qualify for the health claim, foods must contain at least 400 milligrams of phytosterols per serving and at least 80 percent combined weight of the plant sterols beta-sitosterol, campesterol, stigmasterol, sitostanol and campestanol.

Right now a limited number of sterol-enhanced products are in the marketplace—the spreads and some supplements, Bentson says. Benecol and Take Control are the two leading margarine-like spreads that can help lower cholesterol when therapeutic doses are maintained. Harvey says the amount you need for therapeutic benefit comes with both financial and caloric costs. "You have to use it a lot, not just a small amount every day. You have to have continuous use for it to have an effect," he says. Take Control requires one tablespoon twice daily; Benecol requires 1.5 tablespoons daily in three 1.5-teaspoon doses.

Harvey is interested to see what effect the new trans fat labeling regulation will have on these margarines. "Margarine does have higher trans fats because of the [manufacturing] process," he says. "Are people going to shy even further away from that?"

Monica Neufang, a spokeswoman for McNeil Nutritionals, makers of the Benecol spreads and soft gels, says, "Benecol Light spread is not formulated with trans fats, and the Benecol Regular spread has been reformulated and will be available in November." She anticipates most food marketers will reformulate in anticipation of the labeling requirement.

"Just the concept of an ingredient that helps to lower cholesterol would be a natural fit with products that consumers view as healthy."Bentson sees sterol-enhanced products as being an up-and-coming big seller. "Just the concept of an ingredient that helps to lower cholesterol would be a natural fit with products that consumers view as healthy," she says. "So anything people might think of as healthy—cereals, breads, yogurts, that kind of thing—are all natural considerations for incorporating sterols."

The Swiss dairy company Emmi has introduced an Emmi Benecol yogurt drink in Europe. The low-fat drink is said to lower cholesterol with daily consumption. "More products are available in Europe right now," Neufang says, "because the market is more advanced [and] the consumers are more aware of and educated about the benefits of functional foods."

Enhanced milks might also be making their way to market. A team from the Nestlé Research Center in Switzerland tested the cholesterol absorption-inhibiting properties of a phytosterol-fortified milk made partly with vegetable oil. According to results published this year in the European Journal of Clinical Nutrition, cholesterol absorption was reduced from 70 percent with regular milk to 40 percent with the plant-sterol-containing milk.

With solid science backing sterols and the FDA's nod of approval by way of a health claim, retailers can expect to see from marketers a wave of consumer education and a variety of sterol-containing functional foods for lowering cholesterol.

Dena Nishek is a Boulder, Colo.-based freelance writer.

Natural Foods Merchandiser volume XXIV/number 11/p. 24, 28-29

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