Many claims suggesting health beneficial effects of black tea and its components exist in the scientific and lay literature. One such presumed health benefit of tea consumption is decreased risk of cancer. In the United States, each year there are 93,800 new cases and 47,700 deaths due to colon cancer. Among cancer diseases, the evidence for the importance of diet and nutrition is strongest for colon cancer. Therefore, there is a need to find ways to prevent this disease. The overall goal of WellGen, Inc. is to find and develop value-added dietary supplements using sound scientific information. This proposal, entitled "Preciinical Evaluation of Black Tea Extracts" is consistent with our primary goal. Scientific information will be generated in model systems before evaluation in humans. Based on this knowledge, black tea dietary supplements will be developed. Black tea extracts, theaflavin mixtures derived from green tea, and purified chemicals that occur in black tea will be evaluated in three mouse models. All compounds will be evaluated in two mouse ear inflammation assays. Selected compounds will be evaluated in a Min mouse model for colon cancer. The following specific aims are designed to accomplish the overall goal for the 6 months of the Phase 1 study. 1. Prepare standardized, modified theaflavin extracts from decaffeinated green tea 2. Prepare from catechin precursors the following pure compounds: theatlavin(TF-1), theaflavin-3-monogallate and theaflavin-3'-monogallate ( the combination of these two isomers are referred to as TF-2), and theaflavin-3,3'-digallate (TF-3) (200 mg each to evaluate in mouse ear models) 3. Evaluate decaffeinated black tee extract, theaflavin extracts and four pure theaflavin compounds in the 12-O-tetradecanoylphorbol-13 acetate (TPA) and arachidonic acid (AA) induced mouse ear models. 4. Evaluate decaffeinated black tea extract and theaflavin extracts in a Min mouse model 5. Conceptualize and analyze prototype product (dietary supplement) development strategy 6. Plan for biomarker endpoint colon cancer clinical studies
