Botanical Dietary Supplements for Women's Health

促进女性健康的植物膳食补充剂

• 批准号: 8607805
• 负责人: RICHARD B VAN BREEMEN
• 金额: $ 6.07万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8607805
• 关键词: Address; Adopted; Agreement; Animal Model; Basic Science; Biological Assay; Biological Testing; Biometry; Botanicals; Chemicals; Chemistry; Cimicifuga racemosa; Clinical Research; Clinical Trials; Consumption; Development; Drug Prescriptions; Estrogens; Ethics; Evaluation; Faculty; Funding; Goals; Grant; Health; Hepatic; Hormones; Humulus; In Vitro; Industry; Light; Medicine; Metabolism; Ophthalmology; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacognosy; Pharmacy facility; Phase I Clinical Trials; Phase II Clinical Trials; Reporting; Research; Research Personnel; Safety; Sales; Standardization; Surveys; Trifolium pratense; United States National Institutes of Health; Universities; Woman; Women' s Health; base; carcinogenesis; college; dietary supplements; disorder prevention; falls; in vivo; medical schools; metabolomics; middle age; programs; public health relevance; research study; vision science

DESCRIPTION (provided by applicant): The UIC/NIH Center for Botanical Dietary Supplements Research ("UIC/NIH Botanical Center" and "Center") was established in the fall of 1999 to address issues of standardization, quality, safety and efficacy of botanical dietary supplements (BDS). The Center adopted a multi-disciplinary strategy to achieve its basic and clinical research goals. Participating faculty and co-investigators are drawn from the College of Pharmacy's Dept. of Medicinal Chemistry and Pharmacognosy & College of Medicine's Dept. of Ophthalmology and Visual Sciences, Biostatistics Section. Through the Center's subcontractor agreement, faculty with Northwestern University's Feinberg School of Medicine, Department of OBGYN are also represented. The Center focuses its studies on botanicals that are reported to have potential benefit for women's health, and emphasizes the study of their safety profiles, as well as efficacy and mechanism of action. Botanical extracts are subjected to rigorous chemical evaluations (Project 1: Metabolomic characterizations) followed by both in vitro and in vivo biological testing. The Center will study the interaction of frequently used botanicals with estrogen hormones using bioassay and animal models (Project 2). Additionally, botanicals which have already demonstrated an adequate safety profile during previous Center clinical trials will be candidates for a clinical trial to evaluate their safety and efficacy profile in the presence of prescription drugs (Project 3). The trials will study the impact of the botanicals black cohosh, red clover and hops on ethical drugs, from drug classes which undergo hepatic metabolism and are frequently used by mid-life women. Thus, a clearer safety profile of drug-botanical interactions is sought during this grant cycle. Based on an anticipated safety results from a currently conducted Phase I trial, the Center will seek independent funding for a Phase II trial of hops. In order to achieve this agenda for determining the safety of BDS that have been chemically- and biologically-standardized, the renewed BRC research program which emphasizes the safety of botanicals for women's health will be organized around three Projects and four Cores: Project 1: Metabolomic Characterization of Botanical Chemistry and Synergy, Project 2: Botanical Modulation of Estrogen Carcinogenesis, Project 3: Metabolism, Safety and Efficacy, Core A: Administrative and Development, Core B: Botanical Integrity, Core C: Bioassay & Core D: Analytical. The experiments proposed in this application will greatly enhance the scientific understanding of the mechanism of action of botanicals and therefore their efficacy within an enhanced view of safety profiling.

描述（由申请人提供）：UIC/NIH 植物膳食补充剂研究中心（“UIC/NIH 植物中心”和“中心”）成立于 1999 年秋季，旨在解决植物膳食补充剂的标准化、质量、安全性和功效问题膳食补充剂（BDS）。中心采取多学科战略来实现其基础和临床研究目标。参与的教师和共同研究人员来自药学院药物化学和生药学系以及医学院眼科和视觉科学系生物统计学科。通过该中心的分包商协议，西北大学范伯格医学院妇产科的教职人员也派代表参加。该中心的研究重点是据报道对妇女健康具有潜在益处的植物药，并强调对其安全性、功效和作用机制的研究。植物提取物经过严格的化学评估（项目 1：代谢组学表征），然后进行体外和体内生物学测试。该中心将利用生物测定和动物模型研究常用植物药与雌激素的相互作用（项目2）。此外，在之前的中心临床试验中已表现出足够安全性的植物药将成为临床试验的候选药物，以评估其在处方药存在下的安全性和有效性（项目 3）。这些试验将研究植物药黑升麻、红三叶草和啤酒花对伦理药物的影响，这些药物属于经过肝脏代谢并经常被中年女性使用的药物类别。因此，在此资助周期内寻求更清晰的药物-植物相互作用的安全性概况。根据目前进行的第一阶段试验的预期安全结果，该中心将为啤酒花的第二阶段试验寻求独立资金。为了实现确定已化学和生物标准化的 BDS 安全性的议程，新的 BRC 研究计划将围绕三个项目和四个核心进行组织，该计划强调植物药对妇女健康的安全性： 项目 1：代谢组学植物化学和协同作用的表征，项目 2：雌激素致癌作用的植物调节，项目 3：代谢、安全性和功效，核心 A：管理和功效开发，核心 B：植物完整性，核心 C：生物测定和核心 D：分析。本申请中提出的实验将极大地增强对植物药作用机制的科学理解，从而增强对安全性分析的认识。