Solid Sitostanol Formulations Lower LDL-Cholesterol

固体谷甾烷醇制剂降低低密度脂蛋白胆固醇

• 批准号: 6622250
• 负责人: Curtis A Spilburg
• 金额: $ 23.51万
• 依托单位: LIFELINE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-04-01 至 2005-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6622250
• 关键词: antihypercholesterolemic agent; cholesterol; clinical trials; dietary supplements; dosage forms; food additives; gastrointestinal absorption /transport; human subject; human therapy evaluation; hypercholesterolemia; lipid metabolism; low density lipoprotein; nutrition related tag; patient oriented research; sitosterols; water solubility

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.

描述（扫描自申请人摘要）： 食品和胶囊中的水基甾醇/甾烷醇制剂体系 肠胆固醇吸收。这种方法不含脂肪， 与现有的不灵活的以石油为基础的战略相比， 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固醇对 轻度高胆固醇血症成人的LDL-胆固醇降低维持在 美国心脏协会第一阶段饮食将采用两种给药策略 考察在第一，制定大豆甾醇将干混速溶 提供方便的早餐，每天一次给药方案。在第二 战略，大豆甾烷醇将提供胶囊，以确定最佳的 剂量和给药方案。这些方法中的每一种都将在受试者中进行测试 有血脂管理问题的人不属于候选人的儿童 由于长期安全性问题，将招募他汀类药物治疗，并且他们的 LDL-胆固醇降低监测，同时消耗大豆甾醇在即时 早餐同样，服用他汀类药物的成年人， LDL-胆固醇水平将接受大豆甾烷醇胶囊，以确定 使用该辅助治疗降低LDL-胆固醇的程度。积极 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。 拟定商业应用： 一个新的配方系统允许植物甾醇和甾烷醇是有效的胆固醇 水介质中的吸收抑制剂。当这些化合物被掺入胶囊或食品中时，这将用于确定LDL胆固醇的降低。