Healthy, no Evidence of DiseasePhase 1NCT00721877
Resveratrol in Healthy Adult Participants
A Phase 1 study testing resveratrol, pharmacological study and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- resveratrol, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Criteria:
- Healthy adult participants meeting the following criteria:
- Limit cruciferous vegetables to no more than one serving each week for about 6 weeks
- Limit resveratrol-containing foods (i.e., wine, peanuts, mulberries, grapes, cranberries, blueberries, and huckleberries) to no more than one serving each per day for about 6 weeks
- No caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) or food items that have been reported to affect drug/carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) beginning 72 hours before and until 8 hours after each set of CYP probe drug administration
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelet count >= 100,000/uL
- Total bilirubin =< 2.0 mg/dL
- AST/ALT =< 1.5 times upper limit of normal (ULN)
- Creatinine =< ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have a resting systolic blood pressure >= 100 mm Hg at screening and prior to probe drug administration
- Must not consume more than three drinks of alcohol per week on average
- No prior invasive cancers (i.e., non-skin cancer) within the past 5 years
- No history of allergic reactions to resveratrol-containing products or CYP probe drugs (e.g, caffeine, dextromethorphan, losartan, or buspirone)
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- No over-the-counter medications beginning 72 hours before and until 8 hours after each CYP probe drug administration
- No participation in another clinical intervention trial within the past 3 months
- No concurrent medications or supplements that are known CYP enzyme inducers or inhibitors
- No concurrent herbal medicines, dietary supplements, or above-standard vitamins or minerals (a standard daily multivitamin or mineral supplement is acceptable)
- Non-smoking, defined as not currently smoking or stopped smoking more than 1 year ago
- Normal liver and renal function
- Able and willing to adhere to the following dietary restrictions:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center - Tucson
Tucson, Arizona, 85724-5024
About this study
Official title: Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in healthy adult participants.
SECONDARY OBJECTIVES:
- To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug.
OUTLINE:
Participants receive oral resveratrol once daily for 4 weeks.
Patients complete a daily diary documenting adverse events and an intake calendar for recording the daily intake of any non-routine medications.
Participants undergo blood sample collection periodically. Lymphocytes are isolated and analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA assay will be used for quantitative analyses. Urine samples are collected periodically and drug and metabolite levels will be analyzed.
After completion of study treatment, participants are followed for 2 weeks.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- resveratrol, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDrug
Given orally
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Participants receive oral resveratrol once daily for 4 weeks. Receives: Drug: resveratrol; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of CYP enzyme activities
Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).
Measured: From baseline to end of resveratrol intervention
Secondary outcomes (2)
Changes in Phase II enzyme activity
GST activity and GST-pi level in blood lymphocytes and serum bilirubin levels will be used to assess Phase II enzyme activity. Paired t-tests of differences in values from baseline to end of intervention will be used, with a 2-sided significance level of 0.0167 for the three tests.
Measured: From baseline to end of resveratrol intervention
Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Any adverse events will be presented descriptively.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hsiao-Hui (Sherry) Chow, Principal investigator, Arizona Cancer Center - Tucson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721877
- Sponsor's protocol ID
- NCI-2009-00895
- Other IDs
- NCI-2009-00895, 07-0376-04, BIO07-054, CDR0000656389, 07-0376-04, UAZ06-8-01, P30CA023074, N01CN35158
- Status last verified
- Mar 2013
- First submitted
- 24 Jul 2008
- Last updated
- 8 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
- ClinicalTrials.gov ID
- NCT00721877
- Acronym / sponsor ID
- NCI-2009-00895
- Conditions
- Healthy, no Evidence of Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Jul 2008 (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.
Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in healthy adult participants.
SECONDARY OBJECTIVES:
- To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug.
OUTLINE:
Participants receive oral resveratrol once daily for 4 weeks.
Patients complete a daily diary documenting adverse events and an intake calendar for recording the daily intake of any non-routine medications.
Participants undergo blood sample collection periodically. Lymphocytes are isolated and analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA assay will be used for quantitative analyses. Urine samples are collected periodically and drug and metabolite levels will be analyzed.
After completion of study treatment, participants are followed for 2 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: resveratrol, Other: pharmacological study, Other: laboratory biomarker analysisParticipants receive oral resveratrol once daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| resveratrolGiven orally | Drug | Arm I |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
Primary outcome
Modulation of CYP enzyme activities
Time frame: From baseline to end of resveratrol intervention
Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).
2 secondary outcomes
Changes in Phase II enzyme activity
Time frame: From baseline to end of resveratrol intervention
Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: Up to 6 weeks
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 8 Oct 2014.
Related trials for Healthy, no Evidence of Disease
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Active, not recruiting
The Parents in Appalachia Receive Education Needed for Teen Project
Healthy, Human Papilloma Virus Infection
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.
Hsiao-Hui (Sherry) Chow principal investigator
Arizona Cancer Center - Tucson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing resveratrol, pharmacological study and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) 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?
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 8 Oct 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Modulation of CYP enzyme activities (time frame: From baseline to end of resveratrol intervention). 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 8 Oct 2014.