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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01497 | Registry Identifier | National Cancer Institute |
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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.
Primary Objective:
Secondary Objective:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purple Grape Juice | Other | 6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks (change since baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxidized LDL | Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress | 4 weeks |
| Change in Myeloperoxidase (MPO) | Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy K Blair, MPH | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota General Clinical Research Center | Minneapolis | Minnesota | 55455 | United States |
30 recruited; 6 drop-outs during 4 week run-in period, prior to randomization due to now-show for first clinic visit or concerns regarding time, compliance, or blood draws.
Participants were recruited from the Metabolic Syndrome Study in Childhood Cancer Survivors and the Long-Term Follow-up Clinic, both at the University of Minnesota, Minneapolis, MN between October 2009 and May 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 Purple Grape Juice Then Apple Juice | Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2). |
| FG001 | Arm 2 Apple Juice Then Purple Grape Juice | Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Period |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive purple grape juice first and apple juice first |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat analysis | Posted | Aug 2011 | Least Squares Mean | Standard Error | units on a scale | 4 weeks (change since baseline) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Purple Grape Juice | 6 ounces of grape juice consumed twice daily in either the first or second intervention period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy K. Blair, MPH | Masonic Cancer Center, University of Minnesota | 612-624-9668 | blair016@umn.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Apple Juice | Other | 6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization |
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| 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 | 4 weeks |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Measured in kilograms at beginning of study. | Mean | Standard Deviation | kilograms |
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| Height | Measured in centimeters are beginning of study. | Mean | Standard Deviation | Centimeters |
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| Body Mass Index | Measured in kilograms/m^2 at beginning of study. | Mean | Standard Deviation | kg/m^2 |
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| Systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
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| Fasting glucose | Mean | Standard Deviation | mg/dL |
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| Fasting insulin | Mean | Standard Deviation | mU/L |
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| Low-density lipoprotein (LDL) Cholesterol | Mean | Standard Deviation | mg/dL |
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| High-density lipoprotein (HDL) Cholesterol | Mean | Standard Deviation | mg/dL |
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| Triglycerides | Mean | Standard Deviation | mg/dL |
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6 ounces of grape juice consumed twice daily in either the first or second intervention period |
| OG001 | Apple Juice | 6 ounces of clear apple juice consumed twice daily in either the first or second intervention period |
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| Secondary | Change in Oxidized LDL | Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress | Posted | Aug 2011 | Least Squares Mean | Standard Error | Units/Liter | 4 weeks |
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| Secondary | Change in Myeloperoxidase (MPO) | Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 4 weeks |
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| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | mg/L | 4 weeks |
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| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Apple Juice | 6 ounces of clear apple juice consumed twice daily in either the first or second intervention period | 0 | 24 | 0 | 24 |
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