Colon CancerPhase 1NCT00578396
Phase I Biomarker Study of Dietary Grape-derived Low Dose Resveratrol for Colon Cancer Prevention
A Phase 1 study testing grapes in people with Colon Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This study is designed to investigate the dietary influence of grapes in colon cancer prevention. A natural compound found in the skin of grapes, resveratrol, may protect against cancer by acting as an antioxidant (a chemical compound or substance that helps reduce damages due to oxygen). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- grapes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2007
- 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
Who may be able to join
- 18 years of age or older, male or female
- Participants must sign informed consent for enrollment
- Participants must have values for tests included in CBC, CMPAN and UA within normal range or no greater than 1.5x ULN or less than 0.75x LLN at prestudy to proceed to registration
- Participants must have normal limited flexible sigmoidoscopic examination on Day 15 to proceed to re-registration
- To receive Day 28 limited flexible sigmoidoscopy, participants must have taken >80% of prescribed dose of red grapes (based on food diary review)
Who cannot join
- Pregnant or lactating (and/or elevated ßHCG at enrollment)
- Known history of diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
This study is designed to investigate the dietary influence of grapes in colon cancer prevention. A natural compound found in the skin of grapes, resveratrol, may protect against cancer by acting as an antioxidant (a chemical compound or substance that helps reduce damages due to oxygen). This compound is known to block colon cancer cell lines from growing in the laboratory. The purpose of this study is to determine the minimum amount of resveratrol-rich fresh red grapes needed to exhibit such signs of prevention.
Read the detailed description
It has long been recognized that dietary factors influence the risk of developing colon cancer, with populations consuming a higher proportion of fruits and vegetables having lower risk. A compound found in the skin of grapes, resveratrol, has been purported to have colon cancer prevention activity though the dosages obtained through the diet have always seemed too low to produce inhibitory effects against cancer cells in the laboratory. We have found that low concentrations of resveratrol inhibit the Wnt pathway, a key signaling pathway which is activated in over 85% of colon cancers. We have also found in a small pilot trial that low dosages of freeze-dried grape powder can directly inhibit Wnt signaling in the normal colon and that grape powder was more effective than resveratrol alone in blocking Wnt throughput. This suggests that components of grapes may have direct activity in inhibiting a key signaling pathway and that this may correlate with cancer prevention activity.
In this study, we will directly test the impact of a diet containing a specific amount of red grapes in the context of a controlled amount of other resveratrol containing foodstuffs on Wnt signaling in the colon. This grape-supplemented diet provides a low-dose of resveratrol in conjunction with other potentially active components contained within the grapes. Participants will be normal volunteers and molecular studies will be done on colon tissue obtained by a limited flexible sigmoidoscopy before, and after, the red grape-containing diet is ingested. Different dosages of grapes will be utilized. This study will define the effect of dietary grape-derived low dose resveratrol on biomarkers related to the Wnt pathway, and provide critical information as to the utility of this nutritional approach toward colon cancer prevention.
For this study, seedless red grapes will be used. Ten participants will be enrolled at each dose level of grapes as follows:
- Dose level 1: 1 lb/day fresh red grapes
- Dose level 2: 2/3 lb/day fresh red grapes
- Dose level 3: 1/3 lb/day fresh red grapes
Participants will be normal volunteers identified through advertisements, referrals, and community outreach.
Primary Objective:
Define the minimum dietarily achievable amount of resveratrol-rich fresh red grapes which are effective in inhibiting Wnt signaling in human colonic mucosa.
Secondary Objectives
- Define whether grape-supplemented diet affects colonic mucosa cell proliferation.
- Define any side-effects associated with the resveratrol-rich dietary program.
- Conditions
- Colon Cancer
- Being tested
- grapes
- Keywords
- Grapes and colon cancer prevention
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grapesDietary supplement
Also called dietary
1 pound of seedless red grapes
grapesDietary supplement
Also called dietary
2/3 lb/day fresh red grapes
grapesDietary supplement
Also called dietary
1/3 lb/day fresh red grapes
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Active comparator | 1 lb/day fresh red grapes Receives: Dietary Supplement: grapes |
| Dose Level 2 | Active comparator | 2/3 lb/day fresh red grapes Receives: Dietary Supplement: grapes |
| Dose Level 3 | Active comparator | 1/3 lb/day fresh red grapes Receives: Dietary Supplement: grapes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression and cellular localization of beta-catenin in intestinal mucosa: localization of β-catenin. Expression of Wnt pathway target genes in intestinal mucosa: Wnt target gene expression
Measured: 2 yrs
Secondary outcomes (3)
Define whether grape supplemented diet affects colonic mucosa cell proliferation. Ki67 staining method will be utilized on the pre- and post-resveratrol biopsy specimens.
Measured: 2 yrs
Define any side-effects associated with the resveratrol-rich dietary program. Laboratory testing is performed at specified timepoints in this protocol, along with history & physical, for the purposes of toxicity monitoring.
Measured: 2 yrs
Monitor resveratrol content of grapes throughout the course of the study. Grapes will be obtained from the same source as participants monthly throughout the study and the content of resveratrol will be measured.
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Non applicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Randall F Holcombe, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578396
- Sponsor's protocol ID
- OCRT07046
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2007
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Biomarker Study of Dietary Grape-derived Low Dose Resveratrol for Colon Cancer Prevention
- ClinicalTrials.gov ID
- NCT00578396
- Acronym / sponsor ID
- OCRT07046
- Conditions
- Colon Cancer
- Keywords
- Grapes and colon cancer prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Non applicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Gateway for Cancer Research
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Dec 2007 (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.
This study is designed to investigate the dietary influence of grapes in colon cancer prevention. A natural compound found in the skin of grapes, resveratrol, may protect against cancer by acting as an antioxidant (a chemical compound or substance that helps reduce damages due to oxygen). This compound is known to block colon cancer cell lines from growing in the laboratory. The purpose of this study is to determine the minimum amount of resveratrol-rich fresh red grapes needed to exhibit such signs of prevention.
Detailed description
It has long been recognized that dietary factors influence the risk of developing colon cancer, with populations consuming a higher proportion of fruits and vegetables having lower risk. A compound found in the skin of grapes, resveratrol, has been purported to have colon cancer prevention activity though the dosages obtained through the diet have always seemed too low to produce inhibitory effects against cancer cells in the laboratory. We have found that low concentrations of resveratrol inhibit the Wnt pathway, a key signaling pathway which is activated in over 85% of colon cancers. We have also found in a small pilot trial that low dosages of freeze-dried grape powder can directly inhibit Wnt signaling in the normal colon and that grape powder was more effective than resveratrol alone in blocking Wnt throughput. This suggests that components of grapes may have direct activity in inhibiting a key signaling pathway and that this may correlate with cancer prevention activity.
In this study, we will directly test the impact of a diet containing a specific amount of red grapes in the context of a controlled amount of other resveratrol containing foodstuffs on Wnt signaling in the colon. This grape-supplemented diet provides a low-dose of resveratrol in conjunction with other potentially active components contained within the grapes. Participants will be normal volunteers and molecular studies will be done on colon tissue obtained by a limited flexible sigmoidoscopy before, and after, the red grape-containing diet is ingested. Different dosages of grapes will be utilized. This study will define the effect of dietary grape-derived low dose resveratrol on biomarkers related to the Wnt pathway, and provide critical information as to the utility of this nutritional approach toward colon cancer prevention.
For this study, seedless red grapes will be used. Ten participants will be enrolled at each dose level of grapes as follows:
- Dose level 1: 1 lb/day fresh red grapes
- Dose level 2: 2/3 lb/day fresh red grapes
- Dose level 3: 1/3 lb/day fresh red grapes
Participants will be normal volunteers identified through advertisements, referrals, and community outreach.
Primary Objective:
Define the minimum dietarily achievable amount of resveratrol-rich fresh red grapes which are effective in inhibiting Wnt signaling in human colonic mucosa.
Secondary Objectives
- Define whether grape-supplemented diet affects colonic mucosa cell proliferation.
- Define any side-effects associated with the resveratrol-rich dietary program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Active comparator | Dietary Supplement: grapes1 lb/day fresh red grapes |
| Dose Level 2 | Active comparator | Dietary Supplement: grapes2/3 lb/day fresh red grapes |
| Dose Level 3 | Active comparator | Dietary Supplement: grapes1/3 lb/day fresh red grapes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older, male or female
- Participants must sign informed consent for enrollment
- Participants must have values for tests included in CBC, CMPAN and UA within normal range or no greater than 1.5x ULN or less than 0.75x LLN at prestudy to proceed to registration
- Participants must have normal limited flexible sigmoidoscopic examination on Day 15 to proceed to re-registration
- To receive Day 28 limited flexible sigmoidoscopy, participants must have taken >80% of prescribed dose of red grapes (based on food diary review)
Key exclusion criteria (2 listed)
- Pregnant or lactating (and/or elevated ßHCG at enrollment)
- Known history of diabetes
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 |
|---|---|---|
| grapesAlso: dietary1 pound of seedless red grapes | Dietary supplement | Dose Level 1 |
| grapesAlso: dietary2/3 lb/day fresh red grapes | Dietary supplement | Dose Level 2 |
| grapesAlso: dietary1/3 lb/day fresh red grapes | Dietary supplement | Dose Level 3 |
Primary outcome
Expression and cellular localization of beta-catenin in intestinal mucosa: localization of β-catenin. Expression of Wnt pathway target genes in intestinal mucosa: Wnt target gene expression
Time frame: 2 yrs
3 secondary outcomes
Define whether grape supplemented diet affects colonic mucosa cell proliferation. Ki67 staining method will be utilized on the pre- and post-resveratrol biopsy specimens.
Time frame: 2 yrs
Define any side-effects associated with the resveratrol-rich dietary program. Laboratory testing is performed at specified timepoints in this protocol, along with history & physical, for the purposes of toxicity monitoring.
Time frame: 2 yrs
Monitor resveratrol content of grapes throughout the course of the study. Grapes will be obtained from the same source as participants monthly throughout the study and the content of resveratrol will be measured.
Time frame: 2 yrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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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.
Randall F Holcombe, M.D. principal investigator
University of California, Irvine
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 grapes in people with Colon Cancer, run by University of California, Irvine 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 Jan 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Expression and cellular localization of beta-catenin in intestinal mucosa: localization of β-catenin. Expression of Wnt pathway target genes in intestinal mucosa: Wnt target gene expression (time frame: 2 yrs). 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 25 Jan 2021.