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Grant Abstract

Grant Number: 2P50AT000155-11

Abstract: 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. PUBLIC HEALTH RELEVANCE: The UIC/NIH Botanical Center researches botanical dietary supplements (BDS) which have substantial impact on women's health, as determined by consumption via industry sales numbers and national surveys. BDS are consumed by women to promote good health and wellness as well as for the prevention of disease. A better understanding of the safety profile of BDS, as well as mechanism of action and the completion of clinical studies will have important public health relevance in light of the high consumption of BDS.

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