Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.
PRIMARY OBJECTIVES: I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in healthy adult participants. SECONDARY OBJECTIVES: I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug. OUTLINE: Participants receive oral resveratrol once daily for 4 weeks. Patients complete a daily diary documenting adverse events and an intake calendar for recording the daily intake of any non-routine medications. Participants undergo blood sample collection periodically. Lymphocytes are isolated and analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA assay will be used for quantitative analyses. Urine samples are collected periodically and drug and metabolite levels will be analyzed. After completion of study treatment, participants are followed for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
42
Arizona Cancer Center - Tucson
Tucson, Arizona, United States
Modulation of CYP enzyme activities
Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).
Time frame: From baseline to end of resveratrol intervention
Changes in Phase II enzyme activity
GST activity and GST-pi level in blood lymphocytes and serum bilirubin levels will be used to assess Phase II enzyme activity. Paired t-tests of differences in values from baseline to end of intervention will be used, with a 2-sided significance level of 0.0167 for the three tests.
Time frame: From baseline to end of resveratrol intervention
Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Any adverse events will be presented descriptively.
Time frame: Up to 6 weeks
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