Resveratrol in Healthy Adult Participants

NCT00721877 | Completed Phase 1

• 7 other identifiers: NCI-2009-0089507-0376-04BIO07-054CDR0000656389UAZ06-8-01P30CA023074N01CN35158
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Modulation of CYP enzyme activities

  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).

  From baseline to end of resveratrol intervention

Secondary Outcomes (2)

• Changes in Phase II enzyme activity

  From baseline to end of resveratrol intervention

• Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  Up to 6 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

Participants receive oral resveratrol once daily for 4 weeks.

Drug: resveratrol; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

resveratrol DRUG

Given orally

Arm I

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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%

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Arizona Cancer Center - Tucson

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Hsiao-Hui (Sherry) Chow

  Arizona Cancer Center - Tucson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 25, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 8, 2014

Record last verified: 2013-03

Locations

US (1)