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Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

NCT ID: NCT01043939

Last Updated: 2014-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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

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Cardiovascular Disease

Keywords

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childhood cancers cardiovascular disease childhood cancer survivor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Purple Grape Juice First

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

Group Type ACTIVE_COMPARATOR

Purple Grape Juice

Intervention Type OTHER

6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Apple Juice

Intervention Type OTHER

6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Apple Juice First

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

Group Type ACTIVE_COMPARATOR

Purple Grape Juice

Intervention Type OTHER

6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Apple Juice

Intervention Type OTHER

6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Interventions

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Purple Grape Juice

6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Intervention Type OTHER

Apple Juice

6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Intervention Type OTHER

Other Intervention Names

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clear apple juice

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cindy K Blair, MPH

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

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Minnesota General Clinical Research Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2009-01497

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009NTLS074

Identifier Type: -

Identifier Source: org_study_id