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Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes

Phase 1
18 Years
Not Enrolling

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Trial Information

Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes


I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in
healthy adult participants.


I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate
safety in participants treated with this drug.


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.

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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study

- 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

- 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%

Type of Study:


Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Modulation of CYP enzyme activities

Outcome Description:

Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).

Outcome Time Frame:

From baseline to end of resveratrol intervention

Safety Issue:


Principal Investigator

Hsiao-Hui (Sherry) Chow

Investigator Role:

Principal Investigator

Investigator Affiliation:

Arizona Cancer Center - Tucson


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma



Arizona Cancer Center - TucsonTucson, Arizona  85724-5024