Solid Sitostanol Formulations Lower LDL-Cholesterol

描述(摘自申请者摘要)：成立新的 食品和胶囊中的水基甾醇/甾醇配方系统降低 肠道胆固醇吸收。这种方法是无脂肪的，并提供了 与现有僵化的以石油为基础的战略相比有了明显的改进 增加消费者的卡路里负荷。一系列为期14周的双盲安慰剂 对照试验将检查配方类固醇对 轻度高胆固醇血症成人的低密度脂蛋白-胆固醇降低维持在 美国心脏协会第一步节食。两种给药策略将是 检查过了。首先，将配方大豆甾醇与Instant干混 早餐提供方便，每天给药一次养生法。在第二个 策略方面，大豆甾醇将以胶囊形式输送，以确定最佳 剂量和给药方案。这些方法中的每一种都将在受试者身上进行测试 他们有血脂管理方面的问题。不是候选人的孩子 由于长期的安全性考虑，他汀类药物将被纳入治疗方案，他们的 即食大豆类固醇时的低密度脂蛋白-胆固醇降低监测 早餐。同样，服用他汀类药物的成年人没有达到他们的目标 低密度脂蛋白-胆固醇水平将接受胶囊中的大豆甾醇来确定 使用这种辅助治疗的低密度脂蛋白-胆固醇的降低程度。正性 这些研究的结果将提供一种安全的非药物方法 降低胆固醇。 建议的商业应用： 一种新的配方系统使植物甾醇和甾醇成为有效的胆固醇 水介质中的吸收抑制剂。这将被用来确定当这些化合物被合并到胶囊或食品中时，低密度脂蛋白胆固醇的减少。

DESCRIPTION (Scanned from the Applicant's Abstract): 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. PROPOSED COMMERCIAL APPLICATION: 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.