Trial record 1 of 1 for:     Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
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Resveratrol in Healthy Adult Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00721877
First received: July 24, 2008
Last updated: February 21, 2014
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Healthy, no Evidence of Disease
Drug: resveratrol
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Modulation of CYP enzyme activities [ Time Frame: From baseline to end of resveratrol intervention ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Changes in Phase II enzyme activity [ Time Frame: From baseline to end of resveratrol intervention ] [ Designated as safety issue: No ]
    GST activity and GST-pi level in blood lymphocytes and serum bilirubin levels will be used to assess Phase II enzyme activity. Paired t-tests of differences in values from baseline to end of intervention will be used, with a 2-sided significance level of 0.0167 for the three tests.

  • Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
    Any adverse events will be presented descriptively.


Enrollment: 42
Study Start Date: August 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Participants receive oral resveratrol once daily for 4 weeks.
Drug: resveratrol
Given orally
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721877

Locations
United States, Arizona
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
Investigators
Principal Investigator: Hsiao-Hui (Sherry) Chow Arizona Cancer Center - Tucson
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00721877     History of Changes
Other Study ID Numbers: NCI-2009-00895, NCI-2009-00895, 07-0376-04, BIO07-054, CDR0000656389, 07-0376-04, UAZ06-8-01, P30CA023074, N01CN35158
Study First Received: July 24, 2008
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protective Agents
Enzyme Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Pharmacologic Actions
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014