Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01043939
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2010-01-05
Brief Title:
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JAVA
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-01497 | REGISTRY | National Cancer Institute | None |