Executive Summary - June 2002

Plant sterols have been evaluated in many different populations, under different circumstances over the past fifty years, and have consistently demonstrated the ability to reduce blood cholesterol in humans. The scientific substantiation supporting the health benefits of plant sterols has been well established and public health authorities, such as the US National Cholesterol Education Program (NCEP), are beginning to include plant sterols as part of their dietary recommendations (NCEP, 2001).

The need for cholesterol reduction is clear and visible. An estimated 101 million American adults, nearly half the adults in the US, have been classified as having borderline-high or higher total blood cholesterol concentrations (AHA, 2002a).

Public health campaigns continue to emphasize cholesterol control as a means of reducing coronary heart disease (CHD) risk, as exemplified by expanded objectives in the Healthy People 2010, developed by the U.S. National Institutes of Health and the U.S. Centers for Disease Control (NCHS, 2001) and the newly released guidelines of the U.S. National Cholesterol Education Program (NCEP, 2001). The primary focus of these programs is dietary modification, along with increased physical activity, and weight control. In most instances, drug therapy is initiated only after dietary modification has proven to be insufficient in achieving the desired goal (NCEP, 2001; 1993).

Clinical evidence has demonstrated that consumption of both plant sterols and stanols inhibit the intestinal absorption of cholesterol and produce decreases in total blood and LDL cholesterol. Reductions of blood cholesterol have been demonstrated in normocholesterolemic adults and children, hypercholesterolemic populations, diabetics, in individuals on cholesterol-lowering drugs, familial hypercholesterolemics, as well as in individuals with prior coronary events. The effectiveness of these substances has been demonstrated when incorporated into a variety of different foods including margarines or spreads, mayonnaise, pastilles or lozenges, low-fat yogurt, cereal, and bread. While there are a number of variables that affect the magnitude of this benefit, most clinical studies have demonstrated an 8-15% reduction in LDL cholesterol. No adverse clinical effects from the consumption of plant sterols have been reported. The only concern that has been expressed is a reduction of serum carotene levels observed in some of the studies. However, the impact on vitamin A status is theoretical at present and long-term monitoring is taking place. Furthermore, reduced serum carotene levels are readily counteracted by increased consumption of carotene-rich foods.

In the recent Executive Summary of the NCEP's Third Report on the Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, the NCEP recommends adding plant stanols and sterols to the diet to enhance LDL cholesterol-lowering therapy (NCEP, 2001). The FDA also published an interim final health claim rule in September, 2000, affirming the benefit of plant sterol and stanol esters in reducing blood cholesterol levels and reducing coronary heart disease risk (FDA, 2000).

Plant sterols are currently available primarily in spreads, but are being developed in a number of other convenient forms as well. Expansion of consumer choices could assist in meeting the needs of consumers concerned about cholesterol control. While consumers are aware of the need for cholesterol control, they are not as aware of the effectiveness of foods containing plant sterols. Commercialization and marketing of new food products containing ingredients such as Cargill CoroWise™ plant sterols and sterol derivatives could be a significant opportunity for functional food manufacturers to assist consumers in reducing the risk of CHD. Dietary consumption of plant sterols represents an effective method to lower total and LDL cholesterol, a major risk factor for CHD. Dietary consumption of plant sterols represents an effective method to lower total and LDL cholesterol, a major risk factor for CHD.