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Grant Abstract

Grant Number: 5P50AT000474-03
PI Name: Barbara Timmermann
Project Title: Arizona Center for Phytomedicine Research (ACPRX)

Abstract: DESCRIPTION (Applicant's Abstract): The use of dietary supplements containing botanical products is rapidly expanding in the United States. While the public is using these products for a wide range of health-related problems, the safety and efficacy of the products and of their active components have not been tested. The multidisciplinary Arizona Center for Phytomedicine Research (ACPRx) will be established to promote the scientific study of botanicals available to the public as dietary supplements in order to advance the quality and quantity of scientific information about these products. During the first five years, the ACPRx will concentrate its efforts on the research of the safety and efficacy of several botanicals purported to have anti-inflammatory actions and to be specific in the treatment of arthritis or other chronic inflammatory diseases. These botanicals include Curcuma longa rhizome (powdered turmeric root), Zingiber officinale rhizome (powdered ginger root) and the gum resin of Boswellia serrata (boswellia). The three botanicals are commonly recommended for arthritis patients seen at the Integrative Medicine Clinic at the University of Arizona College of Medicine. The initial goals of the ACPRx will be to address the chemistry of active compounds or mixtures of compounds, mechanisms of action, oral bioavailability, pharmacodynamics, and pharmacokinetics. The effect of the botanicals on production of anti-inflammatory mediators will be evaluated in vitro, as well as in an animal model and in human subjects ex vivo. The research component will consist of three projects supported by two research and three administrative cores. Project 1 will isolate and chemically characterize the active constituents by the bioassay-guided approach, conduct biochemical studies to establish mechanism(s) of action of produce standardization of the three botanicals for projects 2 and 3. Project 2 will characterize the pharmacokinetics (following intravenous dosing) and the gastrointestinal absorption kinetics (absolute oral bioavailability, rates of absorption) of commercial formulations (as a function dose) as well as capsules containing pure chemical and active components. Pharmacokinetic and pharmacodynamic interaction among these botanicals will also be assessed. These experiments will use the Yucatan minipig. Project 3 will characterize the basic pharmacokinetics of how the human body handles the active botanical constituents and the pharmacodynamics of their anti-inflammatory activity. This clinical project will perform Phase I clinical trials with each of the three botanicals (from commercially available sources) alone and in combination. Administration Core I will be responsible for the day-to-day administrative details, exchange of data among investigators, house the NAPIS database, program coordination, pilot projects and evaluation of the ACPRx. Administration Cores 2 (Information Collection and Dissemination Unit) and 3 (Consumer and Market Assessment Unit) will act as the consumer education and public information units for the ACPRx. Research Core 1 (Botany/Agronomy) will identify and authenticate botanical ingredients while Core 2 (Analytical LC-MS-MS) will provide analytical support including dereplication, identification, quantitative analysis of active compounds, bioavailability, pharmacokinetic profiles, as well as identification of metabolites in animals and humans. In the future, the ACPRx will expand its research to other botanical dietary supplements in order to help not only the consumer but also health care practitioners.

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