Spots Global Cancer Trial Database for Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers

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Trial Identification

Brief Title: Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers

Official Title: A Pilot Study Evaluating the Bioavailability and Mucosal Bioactivity of the Dietary Supplement, Avmacol®, in Healthy Volunteers With Optimization of Buccal Cell Biomarkers

Study ID: NCT02800265

Conditions

Healthy

Interventions

Avmacol

Study Description

Brief Summary: Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to evaluate both bioavailability and its bioactivity in cheek cells.

Detailed Description: Avmacol is an over-the counter dietary supplement containing broccoli seed and sprout extracts in tablet form. Natural plant substances within Avmacol, called phytochemicals, are hypothesized to stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke. The purpose of this study is twofold: 1) to assess the protective effects of Avmacol on the mucosa (cheek cells) of healthy volunteers, and 2) to assess the collection of cheek cells by scraping, as a less invasive method of studying drug effects in the body compared to drawing blood or a tissue biopsy. Ultimately, these results will be used to design a larger study of Avmacol in patients with tobacco-related head and neck cancer. Avmacol will be studied as a way to possibly prevent a second cancer from developing in these patients.