Research Project
6072169
Plant sterols, such as sitostanol, lower the level of human serum cholesterol by inhibiting its absorption from the small intestine. Even though sitostanol has minimal toxicity and is not absorbed itself, previous attempts to use this plant stanol for cholesterol lowering have been complicated by its low solubility in water and dietary oils. Using an innovative mass spectrometry method to replace conventional long-term clinical trials, a new aqueous sitostanol formulation has been shown to reduce human cholesterol absorption by 37%. Importantly, this was achieved with only 300 mg of sitostanol, an amount that is 5- to 10-fold less than that previously reported to be effective. In order to develop a composition and dose size for a commercial preparation, this study will evaluate by mass spectrometry various solid sitostanol formulations as inhibitors of human cholesterol absorption. The work described here will produce a flexible solid formulation that can be used in a tablet for a dietary supplement or as a solid additive for a food ingredient. The versatility of this formulation and the acknowledged safety of sitostanol will provide better therapy for individuals with mildly elevated serum cholesterol, a group that is currently not served by conventional pharmaceuticals. PROPOSED COMMERCIAL APPLICATIONS: Plant sterols can serve as cholesterol absorption inhibitors since they are safe and well tolerated. This proposal describes studies to prepare a solid sitostanol formulation that can be used as a dietary supplement or as a food ingredient.
