NCT01324089

Brief Summary

There is some evidence that when resveratrol (a substance which is found in red grapes, peanuts and chocolate) is combined with Piperine (a substance found in pepper) it is more effective in fighting cancer. The purpose of this study is to see if resveratrol in combination with piperine is more effective than taking resveratrol alone. Since investigators don't know what dose of piperine to use in combination with resveratrol, two different doses of piperine will be studied. Twenty-four participants, equal numbers of males and females, will receive a single dose of resveratrol (2.5 grams) without piperine, resveratrol (2.5 grams) with piperine (5 mg), or resveratrol (2.5 grams) with piperine (25 mg).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 13, 2019

Status Verified

May 1, 2013

Enrollment Period

8 months

First QC Date

March 8, 2011

Last Update Submit

December 12, 2019

Conditions

Focus of the Study: Normal Volunteers

Keywords

ResveratrolPiperine

Outcome Measures

Primary Outcomes (1)

  • Blood levels of study drugs

    Blood levels of Resveratrol/Piperine will be measured

    30 days

Secondary Outcomes (1)

  • Side effects of study drugs

    30 days

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Resveratrol 2.5 grams x 1 dose

Dietary Supplement: Resveratrol

Arm 2

EXPERIMENTAL

Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose

Dietary Supplement: Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose

Arm 3

OTHER

Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose

Dietary Supplement: Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose

Interventions

ResveratrolDIETARY_SUPPLEMENT

Resveratrol 2.5 grams

Arm 1
Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 doseDIETARY_SUPPLEMENT

Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose

Arm 2
Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 doseDIETARY_SUPPLEMENT

Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose

Arm 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Resveratrolpiperine

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Howard H Bailey, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 28, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

December 13, 2019

Record last verified: 2013-05

Locations

US(1)