Resveratrol in Healthy Adult Participants

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Healthy, no Evidence of Disease

Treatments

Other: laboratory biomarker analysis

Other: pharmacological study

Drug: resveratrol

Study type

Interventional

Funder types

NIH

Identifiers

NCT00721877

NCI-2009-00895 (Registry Identifier)

P30CA023074 (U.S. NIH Grant/Contract)

CDR0000656389

07-0376-04

UAZ06-8-01 (Other Identifier)

N01CN35158 (U.S. NIH Grant/Contract)

BIO07-054

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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%