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A Randomized, Double-Blind Pilot Trial of Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

18 Years
65 Years
Not Enrolling
Focus of the Study: Normal Volunteers

Thank you

Trial Information

A Randomized, Double-Blind Pilot Trial of Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

Inclusion Criteria:

- Men and women age 18 to 65 years old, inclusive

- Women and men must agree to use an effective form of birth control prior to study
entry and for the duration of study participation

- Willingness to abstain from foods containing resveratrol for 3 days prior to single
dose administration and for 7 days after dosing. (Examples include red grapes, grape
juice, peanuts, peanut butter.)

- Abstain from vitamin supplements from 2 weeks before study dosing and for 7 days
following study dosing

- Eastern Cooperative Oncology Group performance status ≤ 1 (Karnofsky > 70%)

- Participants must have normal organ and hepatic functions

- Participants must abstain from alcohol beverages 72 hours prior to dosing with the
study agent, and for 7 days after dosing.

Exclusion Criteria:

- Participants who require daily medication, either prescription or over the counter
(with the exception of birth control pills) will be considered ineligible.
Participants who occasionally use medication (such as for pain relief or allergies)
will be considered eligible; however, these participants must agree to refrain from
using prn medications starting at midnight prior to the inpatient period and for
seven days following dosing.

- Any cancer diagnosis within the past 5 years (except basal cell carcinoma or squamous
cell carcinoma).

- Participants may not be currently receiving any other investigational agent(s) or
have taken any within the past 9 months.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition of resveratrol and/or piperine.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Blood levels of study drugs

Outcome Description:

Blood levels of Resveratrol/Piperine will be measured

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Howard H Bailey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:

CO 10308



Start Date:

March 2011

Completion Date:

March 2012

Related Keywords:

  • Focus of the Study: Normal Volunteers
  • Resveratrol
  • Piperine



University of Wisconsin Madison,, Wisconsin  53792-5666