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植物饮食补充剂研究中心（“ UIC/NIH植物中心”和“中心”）于1999年秋季建立，以解决植物饮食补充剂（BDS）（BDS）的标准化，质量，安全性和有效性的问题。该中心采用了多学科策略来实现其基本和临床研究目标。参与的教职员工和共同研究者来自药学学院的药物化学系和药学和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Feinberg医学院的教职员工也代表了Obgyn系。该中心将其研究重点放在据报道对妇女健康有潜在利益的植物上，并强调研究其安全概况以及作用机理。植物提取物受到严格的化学评估（项目1：代谢组性表征），然后是体外和体内生物学测试。该中心将使用生物测定和动物模型研究经常使用的植物药与雌激素的相互作用（项目2）。此外，在上一次中心临床试验期间已经表现出足够的安全性的植物学将是临床试验的候选者，以评估处方药存在下的安全性和功效（项目3）。这些试验将研究植物性黑色同座，红三叶草和啤酒花对伦理药物的影响，这些药物是从事肝代谢的药物类别，并且经常被中年妇女使用。因此，在此赠款周期中寻求了药物相互作用的更明显的安全性。基于当前进行的I期试验的预期安全结果，该中心将寻求独立的啤酒花试验资金。 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和功效，核心A：行政和发展，核心B：植物完整性，核心C：生物测定和核心D：分析。本应用程序中提出的实验将大大增强对植物作用机理的科学理解，因此在增强的安全分析视野中其功效。