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Grant Abstract

Grant Number: 3P50AT000155-05S2
PI Name: Norman Farnsworth
Project Title: Botanical Dietary Supplements for Women's Health

Abstract: DESCRIPTION: (verbatim from the applicant's abstract) The Center for Dietary Supplements Research on botanicals will consist of a multidisciplinary team of investigators who will focus their initial efforts on the study of the clinical safety and efficacy of botanicals used to treat women's health with particular emphasis on therapies for menopause. Additional studies will address mechanisms of action, identification of active compounds, and characterization of metabolism, bioavailability and pharmacokinetics of active species contained in these botanicals. The research component will consist of four projects, which will be supported by three cores as follows: Project 1. This pharmacognosy project will carry out standardization of botanical dietary supplements and structure elucidation of active compounds using bioassay-guided fractionation in collaboration with Project 2. Project 2 will use bioassay-guided fractionation to isolate active compounds for structure elucidation, and then will carry out biochemical studies to determine the mechanism(s) of botanicals used for women's health. Project 3. Novel in vitro methods for the study of metabolism, absorption and toxicity of active compounds in botanicals will be developed and applied during this project. Immunotoxicity of botanical preparations will be evaluated. Project 4. This Clinical Project will carry out Phase I and Phase II clinical trials of black cohosh (Cimicifugae racemosa) and red clover (Trifolium pratense). Phase I studies will focus on human toxicity, absorption, distribution, metabolism and elimination of active compounds, and in Phase II, efficacy for the relief of menopausal symptoms will be evaluated. Core A. This Administrative Core will facilitate the exchange of data between investigators, coordinate data archiving, will provide administrative assistance and statistical support, and will coordinate meetings with the Advisory Committee. Core B. The Education and Information Core will be responsible for pharmacognosy curriculum development and the implementation of graduate and post-doctoral training programs, for the implementation of interactive on-line learning and continuing education programs, phone-in services for the public, and botanical information database searches. Core C. The LC-MS-MS Core will provide analytical support including: identification/dereplication and quantitative analysis of active compounds; bioavailability and pharmacokinetic profiles, and identification of urinary metabolites. With these research facilities in place, the Center will be positioned to expand its efforts in the future to include studies on other botanicals used for a wider range of human health issues.

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