Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

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

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).

Study Overview

• Status: Completed
• Conditions: Focus of the Study: Normal Volunteers
• Intervention / Treatment: Dietary supplement: Resveratrol; Dietary supplement: 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 25 mg x 1 dose

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Resveratrol 2.5 grams x 1 dose	Dietary supplement: Resveratrol; Resveratrol 2.5 grams
Experimental: Arm 2; 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; Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose
Other: Arm 3; 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; Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood levels of study drugs	Blood levels of Resveratrol/Piperine will be measured	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of study drugs	Adverse events or side effects	30 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 25, 2011
• First Posted (Estimate): March 28, 2011

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Resveratrol; Piperine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Cytochrome P-450 Enzyme Inhibitors; Antioxidants; Resveratrol; Piperine
• Other Study ID Numbers: CO 10308; A534260 (Other Identifier: UW Madison); SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison); R21CA149560 (U.S. NIH Grant/Contract); NCI-2012-00072 (Registry Identifier: NCI Trial ID); 2010-0356 (Other Identifier: Institutional Review Board)