Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

NCT ID: NCT01324089

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-03-31

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).

Conditions

Focus of the Study: Normal Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Resveratrol 2.5 grams x 1 dose

Group Type: ACTIVE_COMPARATOR

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Resveratrol 2.5 grams

Arm 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Arm 3

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

Group Type: OTHER

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Resveratrol

Resveratrol 2.5 grams

Intervention Type: DIETARY_SUPPLEMENT

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

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

Intervention Type: DIETARY_SUPPLEMENT

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

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard H Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

R21CA149560

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\HEM-ONC

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00072

Identifier Type: REGISTRY

Identifier Source: secondary_id

2010-0356

Identifier Type: OTHER

Identifier Source: secondary_id

CO 10308

Identifier Type: -

Identifier Source: org_study_id