PHARMACOLOGY OF COMBINED EPHEDRINE/CAFFEINE SUPPLEMENTS

麻黄碱/咖啡因复合补充剂的药理学

• 批准号: 6630531
• 负责人: CHRISTINE A HALLER
• 金额: $ 12.18万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-28 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6630531
• 关键词: alternative medicine; caffeine; cardiovascular function; central nervous system stimulants; clinical research; dietary supplements; drug interactions; drug quality /standard; ephedrine; exercise; human subject; nutrition related tag; pharmacokinetics; plant extracts; thermogenesis

DESCRIPTION (Applicant's Abstract): Dietary supplements containing plant-derived ephedrine (ma huang) and caffeine (guarana) are widely promoted and used for weight loss, body building and exercise enhancement. Amidst reports of numerous adverse events, regulatory changes regarding ephedrine/caffeine-containing dietary supplements are being considered including changes in warning statements, dose limits and product claims. Few scientific studies have addressed the pharmacologic effects of plant-derived ephedrine and caffeine during rest or exercise. Drs Haller and Benowitz propose clinical research studies aimed at generating pharmacokinetic and pharmacodynamic data on ma huang/guarana-containing supplements to guide regulatory policy regarding the safety of marketing these products. Specific studies will examine the following: Hypothesis 1. These products are not subject to the same pre-market testing requirements as drugs and may contain more or less quantities of active constituents than declared on the product label. We aim to meausre levels of ephedrine alkaloids and methylxanthines in 4 lots of 6 commercial brands and perform a broad screen for drugs and contaminants. Hypothesis 2: Plant-derived ephedrine and caffeine may have different pharmacological properties than pure rug onus. Other herbal ingredients in commercial products may augment the stimulant effects of ephedrine and caffeine. We aim to characterize the pharmacokinetics of plant-derived ephedrine and caffeine taken in combination with other herbs as marketed compared to pure ephedrine and caffeine, alone and in combination, and measure clinical effects under resting conditions. Hypothesis 3: Increases in heart rate and blood pressure that occur during exercise may be augmented by sympathomirruetic effects of ephedrine and caffeine taken together. Other herbal ingredients in thermogenic supplements may aggravate these stimulant effects. We aim to compare the clinical effects of plant-derived ephedrine and caffeine dietary supplements compared to pure ephedrine and caffeine alone and together when taken prior to strenuous exercise. Additional studies will address the effects of individual risk factors such as gender, hypertension and diabetes and dose response and multiple dose regimens. The long-term objective for the proposed studies is to develop Dr. Haller into an independent career clinical researcher in this field of study.

描述（申请人摘要）：膳食补充剂含有 植物来源的麻黄碱（麻黄）和咖啡因（瓜拉那）得到广泛推广 并用于减肥、健身和增强运动。之中 大量不良事件的报告，有关监管的变化 正在考虑含麻黄碱/咖啡因的膳食补充剂 包括警告声明、剂量限制和产品声明的变化。很少 科学研究已经解决了植物来源的药理作用 休息或运动时服用麻黄碱和咖啡因。哈勒博士和贝诺维茨博士提议 旨在产生药代动力学和 含麻黄/瓜拉那补充剂的药效学数据来指导 有关这些产品营销安全的监管政策。具体的 研究将检验以下内容： 假设 1. 这些产品不是 须遵守与药品相同的上市前测试要求，并且可能包含 活性成分的数量多于或少于产品上声明的数量 标签。我们的目标是测量 4 种药物中麻黄碱生物碱和甲基黄嘌呤的含量 大量 6 个商业品牌，对药品和药物进行广泛筛选 污染物。假设2：植物来源的麻黄碱和咖啡因可能具有 与纯地毯不同的药理特性。其他草药 商业产品中的成分可能会增强刺激作用 麻黄碱和咖啡因。我们的目标是表征药代动力学 植物来源的麻黄碱和咖啡因与其他草药组合服用 与单独或组合销售的纯麻黄碱和咖啡因相比，以及 测量静息条件下的临床效果。假设 3：增加 运动期间发生的心率和血压可能会增加 麻黄碱和咖啡因一起服用会产生交感神经作用。其他 生热补充剂中的草药成分可能会加剧这些兴奋剂 影响。我们的目的是比较植物源麻黄碱和 咖啡因膳食补充剂与纯麻黄碱和咖啡因的单独比较 剧烈运动前一起服用。额外的研究将 解决性别、高血压等个体风险因素的影响 糖尿病与剂量反应和多剂量方案。长期目标 拟议的研究旨在将哈勒博士发展为独立的职业 该研究领域的临床研究员。