Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

Study Overview
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Brief Summary
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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).

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

Conditions
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Focus of the Study: Normal Volunteers

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Resveratrol 2.5 grams x 1 dose | Dietary Supplement: Resveratrol<br>* Resveratrol 2.5 grams<br>|
| Experimental: Arm 2<br>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<br>* Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose<br>|
| Other: Arm 3<br>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<br>* Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resveratrol, Piperine