This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objectives will be accomplished by performing a study in which a group of people will consume a defined amount of potato chips containing a known amount of endogenous acrylamide over a period of six weeks. Biomarkers for acrylamide exposure will be determined and changes in biomarker concentrations over time will be assessed. The design of this study is based on similar types of investigations in which the effect of the consumption of nuts on blood lipid levels was determined (1;2). Further, information obtained in a pilot study is also used to determine exclusion criteria and to verify sample size calculations. The study participants will be randomly- divided in a potato chips-eating group and a control group. The volunteers of the potato chips-eating group will be asked to eat a certain amount of potato chips daily over a period of five weeks, while the control group will receive a product known to be low in its acrylamide concentration. The cumulative intake of acrylamide through potato chips will be compared with the biomarker concentrations measured over the duration of the study. Correlations between the cumulative exposure and these biomarker concentrations are to be assessed. Known confounders such as exposure to tobacco smoke and profound changes in dietary behavior or life-style within an approximately four month prior to and during the study will be assessed and taken into consideration. Thirty-six subjects are needed in one group to detect a 12% change in biomarker levels. This calculation is based on an one-sided test at the 0.05 level and 80% power assuming an intra-subject variability of 20% and an analytical variability of 15%. Because a potato chips eating group and a control group is needed, a total of 100 subjects is needed (including a drop-out rate of about 30%). This study is the first to investigate whether there is an overall effect of acrylamide intake on biomarker concentrations and is not designed to study the impact of gender, race or ethnicity on the outcome in this pilot; this can be done in future studies.
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