Incorporation of a new water-based sterol/stanol formulation system in foods and capsules lowers intestinal cholesterol absorption. This methodology is fat-free and provides a distinct improvement over existing inflexible oil-based strategies that increase the consumer's caloric load. A series of 14-week, double blind placebo controlled trials will examine the effect of formulated sterols on LDL-cholesterol reduction in mildly hypercholesterolemic adults maintained on the American Heart Association Step I diet. Two dosing strategies will be examined. In the first, formulated soy sterols will be dry blended with Instant Breakfast to provide a convenient, once a day dosing regimen. In the second strategy, soy stanols will be delivered in capsules to determine the optimum dose and dosing regimen. Each of these methods will then be tested in subjects who have problems with lipid management. Children who are not candidates for statin therapy because of long-term safety concerns will be enrolled and their LDL-cholesterol reduction monitored while consuming soy sterols in Instant Breakfast. Similarly, adults on statin drugs who have not reached their target LDL-cholesterol level will receive soy stanols in capsules to determine the extent of LDL-cholesterol reduction using this adjunct therapy. Positive results from these studies will provide a safe non-pharmaceutical approach to cholesterol reduction.
A new formulation system allows plant sterols and stanols to be effective cholesterol absorption inhibitors in aqueous media. This will be used to determine the reduction in LDL cholesterol when these compounds are incorporated in capsules or a food product.
