Focus of the Study: Normal VolunteersNCT01324089
Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol
A study testing Resveratrol, Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose and Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose in people with Focus of the Study: Normal Volunteers, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study: Normal Volunteers
- What is being tested?
- Resveratrol, Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose and Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Focus of the Study: Normal Volunteers
- Being tested
- Resveratrol, Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose, Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose
- Keywords
- Resveratrol, Piperine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Resveratrol 2.5 grams
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
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Resveratrol 2.5 grams x 1 dose Receives: Dietary Supplement: Resveratrol |
| Arm 2 | Experimental | Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose Receives: 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 Receives: Dietary Supplement: Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of study drugs
Blood levels of Resveratrol/Piperine will be measured
Measured: 30 days
Secondary outcomes (1)
Side effects of study drugs
Adverse events or side effects
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study: Normal VolunteersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Howard H Bailey, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324089
- Sponsor's protocol ID
- CO 10308
- Other IDs
- R21CA149560, A534260, SMPH\MEDICINE\HEM-ONC, NCI-2012-00072, 2010-0356
- Status last verified
- May 2013
- First submitted
- 8 Mar 2011
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Pilot Trial of Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol
- ClinicalTrials.gov ID
- NCT01324089
- Acronym / sponsor ID
- CO 10308
- Conditions
- Focus of the Study: Normal Volunteers
- Keywords
- Resveratrol, Piperine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Dietary Supplement: ResveratrolResveratrol 2.5 grams x 1 dose |
| Arm 2 | Experimental | Dietary Supplement: Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 doseResveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose |
| Arm 3 | Other | Dietary Supplement: Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 doseResveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolResveratrol 2.5 grams | Dietary supplement | Arm 1 |
| Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 doseResveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose | Dietary supplement | Arm 2 |
| Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 doseResveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose | Dietary supplement | Arm 3 |
Primary outcome
Blood levels of study drugs
Time frame: 30 days
Blood levels of Resveratrol/Piperine will be measured
1 secondary outcome
Side effects of study drugs
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard H Bailey, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol, Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose and Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose in people with Focus of the Study: Normal Volunteers, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels of study drugs (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.