Resveratrol in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy, no Evidence of Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm I

Participants receive oral resveratrol once daily for 4 weeks.

Group Type EXPERIMENTAL

resveratrol

Intervention Type DRUG

Given orally

pharmacological study

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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resveratrol

Given orally

Intervention Type DRUG

pharmacological study

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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pharmacological studies

Eligibility Criteria

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Inclusion 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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes