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21 in placebo*

protease) in the lungs of ferrets; however, lycopene supplementation reversed the smoke-induced suppression of apo-ptosis and prevented the smoke-induced elevation of BAD phosphorylation.14 These findings, along with other recent studies,15 begin to elucidate the potential chemopreventive capacity and limitations of carotenoids, as well as the mechanisms underlying the effects of b-carotene on lung cancer observed in human trials.

Evidence from Pharmacokinetic and Pharmacodynamic Research

Limited pharmacokinetic research was conducted before the trials, and determinations of an optimal dose and the duration of supplementation were not established. Single-dose studies of b-carotene that demonstrated peak plasma response within 24 to 48 hours were conducted in healthy young men before the trials.16 Chronic-dose studies, ranging from 15 to 180mg/day b-carotene, were conducted in healthy participants at the same time as the trials.17-19 The chronic-dose studies began to reveal large interindividual variation in response to the varying dosages. Along with limited information on the bioavailability of b-carotene was the issue of identifying responders from nonresponders, a phenomenon later reported in trial participants.20 Human nutrition research was not conducted to test the effects of b-carotene supplementation in high-risk groups such as smokers and drinkers of alcohol in the ATBC and CARET. The publication of adverse effects in human trials led to animal research as the only ethical approach to examine the interaction of multiple risk behaviors and a pharmaceutical dose supplementation as well as the complex molecular pathways leading to lung carcinogenesis.

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