Status:
COMPLETED
Resveratrol in Healthy Adult Participants
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Healthy, no Evidence of Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 effe...
Eligibility Criteria
Inclusion
- Criteria:
- Healthy adult participants meeting the following criteria:
- Limit cruciferous vegetables to no more than one serving each week for about 6 weeks
- Limit resveratrol-containing foods (i.e., wine, peanuts, mulberries, grapes, cranberries, blueberries, and huckleberries) to no more than one serving each per day for about 6 weeks
- No caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) or food items that have been reported to affect drug/carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) beginning 72 hours before and until 8 hours after each set of CYP probe drug administration
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelet count \>= 100,000/uL
- Total bilirubin =\< 2.0 mg/dL
- AST/ALT =\< 1.5 times upper limit of normal (ULN)
- Creatinine =\< ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have a resting systolic blood pressure \>= 100 mm Hg at screening and prior to probe drug administration
- Must not consume more than three drinks of alcohol per week on average
- No prior invasive cancers (i.e., non-skin cancer) within the past 5 years
- No history of allergic reactions to resveratrol-containing products or CYP probe drugs (e.g, caffeine, dextromethorphan, losartan, or buspirone)
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- No over-the-counter medications beginning 72 hours before and until 8 hours after each CYP probe drug administration
- No participation in another clinical intervention trial within the past 3 months
- No concurrent medications or supplements that are known CYP enzyme inducers or inhibitors
- No concurrent herbal medicines, dietary supplements, or above-standard vitamins or minerals (a standard daily multivitamin or mineral supplement is acceptable)
- Non-smoking, defined as not currently smoking or stopped smoking more than 1 year ago
- Normal liver and renal function
- Able and willing to adhere to the following dietary restrictions:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00721877
Start Date
August 1 2008
End Date
July 1 2009
Last Update
October 8 2014
Active Locations (1)
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1
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024