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Resveratrol in Healthy Adult Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00721877
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 24, 2008
First Posted Date  ICMJE July 25, 2008
Last Update Posted Date October 8, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
Modulation of CYP enzyme activities [ Time Frame: From baseline to end of resveratrol intervention ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2008)
Comparison of CYP enzyme activity as assessed by plasma caffeine and paraxathine levels from baseline to end of resveratrol intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Changes in Phase II enzyme activity [ Time Frame: From baseline to end of resveratrol intervention ]
    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 ]
    Any adverse events will be presented descriptively.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2008)
  • Assessment of modulation of phase II enzyme activity as assessed by GST activity and GST-pi levels in blood lymphocytes and serum bilirubin level from baseline to end of resveratrol intervention
  • Safety as measured by assessing the frequency and severity of adverse events, blood chemistry, and hematology
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resveratrol in Healthy Adult Participants
Official Title  ICMJE Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy, no Evidence of Disease
Intervention  ICMJE
  • Drug: resveratrol
    Given orally
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Arm I
Participants receive oral resveratrol once daily for 4 weeks.
Interventions:
  • Drug: resveratrol
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2008)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00721877
Other Study ID Numbers  ICMJE NCI-2009-00895
NCI-2009-00895 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
07-0376-04
BIO07-054
CDR0000656389
07-0376-04 ( Other Identifier: Arizona Cancer Center - Tucson )
UAZ06-8-01 ( Other Identifier: DCP )
P30CA023074 ( U.S. NIH Grant/Contract )
N01CN35158 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hsiao-Hui (Sherry) Chow Arizona Cancer Center - Tucson
PRS Account National Cancer Institute (NCI)
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP