Resveratrol in Healthy Adult Participants

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Resveratrol

Criteria

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%