Clinical trial NCT00721877: Resveratrol in Healthy Adult Participants
Official title: Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, no Evidence of Disease
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-07-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility 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%

Primary outcomes:
measure: Modulation of CYP enzyme activities
timeFrame: From baseline to end of resveratrol intervention
Secondary outcomes:
measure: Changes in Phase II enzyme activity
timeFrame: From baseline to end of resveratrol intervention
measure: Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center - Tucson
state: Arizona
Study officials:
affiliation: Arizona Cancer Center - Tucson
name: Hsiao-Hui (Sherry) Chow
role: PRINCIPAL_INVESTIGATOR
References: