Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01324089
First received: March 8, 2011
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Focus of the Study: Normal Volunteers
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
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind Pilot Trial of Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Blood levels of study drugs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Blood levels of Resveratrol/Piperine will be measured


Secondary Outcome Measures:
  • Side effects of study drugs [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Adverse events or side effects


Enrollment: 24
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324089

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Howard H Bailey, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01324089     History of Changes
Other Study ID Numbers: CO 10308, R21CA149560
Study First Received: March 8, 2011
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
Resveratrol
Piperine

Additional relevant MeSH terms:
Resveratrol
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014