Cardiovascular DiseasePhase 1JAVANCT01043939
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
A Phase 1 study testing Purple Grape Juice and Apple Juice in people with Cardiovascular Disease, run by University of Minnesota at 1 site in United States.
Trial summary
Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Purple Grape Juice and Apple Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with cancer > 5 years ago
- Off-maintenance therapy for > 36 months
- Age 10-30 years
- Reside within a 50 mile radius of the University of Minnesota
Who cannot join
- Pregnant or planning to become pregnant
- Start of oral contraceptives < or = 3 months prior to study enrollment
- Current smoker
- Diabetes (type 1 and 2)
- Antibiotic use < 2 weeks prior to study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota General Clinical Research Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors
Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.
Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.
Read the detailed description
Primary Objective:
- To evaluate the effect of PGJ on endothelial function, a key measure of vascular health and considered a barometer for cardiovascular disease risk.
Secondary Objective:
- To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.
Outline:
Patients undergo a 4-week washout period and refrain from consuming any type of juice, juice drink (less than 100% juice), wine or grapes. Patients are then randomized to 1 of 2 arms.
Arm 1: Beginning in week 4, patients consume 6 ounces of purple grape juice (PGJ) twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume apple juice (AJ) as in Arm 2.
Arm 2: Beginning in week 4, patients consume 6 ounces of AJ twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume PGJ as in Arm 1.
- Conditions
- Cardiovascular Disease
- Being tested
- Purple Grape Juice, Apple Juice
- Keywords
- childhood cancers, cardiovascular disease, childhood cancer survivor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purple Grape JuiceOther
6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
Apple JuiceOther
Also called clear apple juice
6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
| Study group | Role | What they receive |
|---|---|---|
| Purple Grape Juice First | Active comparator | After 4 week run-in period, drink 6 ounces of purple grape juice twice daily, then 4 week washout, week 12 drink 6 ounces of clear apple juice for 4 weeks twice daily Receives: Other: Purple Grape Juice; Other: Apple Juice |
| Apple Juice First | Active comparator | After 4 week run-in period, drink 6 ounces of clear apple juice twice daily, then 4 week washout, week 12 drink 6 ounces of purple grape juice for 4 weeks twice daily Receives: Other: Purple Grape Juice; Other: Apple Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)
Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.
Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during \& after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function.
Measured: 4 weeks (change since baseline)
Secondary outcomes (3)
Change in Oxidized LDL
Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress
Measured: 4 weeks
Change in Myeloperoxidase (MPO)
Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress
Measured: 4 weeks
Change in High Sensitivity C-Reactive Protein (Hs-CRP)
Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy K Blair, MPH, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043939
- Sponsor's protocol ID
- 2009NTLS074
- Other IDs
- NCI-2009-01497
- Acronym
- JAVA
- Status last verified
- Dec 2014
- First submitted
- 5 Jan 2010
- Last updated
- 31 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT01043939
- Acronym / sponsor ID
- JAVA / 2009NTLS074
- Conditions
- Cardiovascular Disease
- Keywords
- childhood cancers, cardiovascular disease, childhood cancer survivor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 29 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.
Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.
Detailed description
Primary Objective:
- To evaluate the effect of PGJ on endothelial function, a key measure of vascular health and considered a barometer for cardiovascular disease risk.
Secondary Objective:
- To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.
Outline:
Patients undergo a 4-week washout period and refrain from consuming any type of juice, juice drink (less than 100% juice), wine or grapes. Patients are then randomized to 1 of 2 arms.
Arm 1: Beginning in week 4, patients consume 6 ounces of purple grape juice (PGJ) twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume apple juice (AJ) as in Arm 2.
Arm 2: Beginning in week 4, patients consume 6 ounces of AJ twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume PGJ as in Arm 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purple Grape Juice First | Active comparator | Other: Purple Grape Juice, Other: Apple JuiceAfter 4 week run-in period, drink 6 ounces of purple grape juice twice daily, then 4 week washout, week 12 drink 6 ounces of clear apple juice for 4 weeks twice daily |
| Apple Juice First | Active comparator | Other: Purple Grape Juice, Other: Apple JuiceAfter 4 week run-in period, drink 6 ounces of clear apple juice twice daily, then 4 week washout, week 12 drink 6 ounces of purple grape juice for 4 weeks twice daily |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with cancer > 5 years ago
- Off-maintenance therapy for > 36 months
- Age 10-30 years
- Reside within a 50 mile radius of the University of Minnesota
Key exclusion criteria (5 listed)
- Pregnant or planning to become pregnant
- Start of oral contraceptives < or = 3 months prior to study enrollment
- Current smoker
- Diabetes (type 1 and 2)
- Antibiotic use < 2 weeks prior to study enrollment
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 |
|---|---|---|
| Purple Grape Juice6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization | Other | Apple Juice First, Purple Grape Juice First |
| Apple JuiceAlso: clear apple juice6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization | Other | Apple Juice First, Purple Grape Juice First |
Primary outcome
Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)
Time frame: 4 weeks (change since baseline)
Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function. Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during \& after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function.
3 secondary outcomes
Change in Oxidized LDL
Time frame: 4 weeks
Change in Myeloperoxidase (MPO)
Time frame: 4 weeks
Change in High Sensitivity C-Reactive Protein (Hs-CRP)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cindy K Blair, MPH principal investigator
Masonic Cancer Center, University of Minnesota
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 Purple Grape Juice and Apple Juice in people with Cardiovascular Disease, run by University of Minnesota 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 4 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 31 Dec 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?
Yes. Results are posted in the registry (first posted 29 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score) (time frame: 4 weeks (change since baseline)). 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 31 Dec 2014.