Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors (JAVA)

University of Minnesota (UMN)

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Disease

Treatments: Other: Purple Grape Juice; Other: Apple Juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01043939

2009NTLS074

NCI-2009-01497 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Purple Grape Juice First

Active Comparator group

Description:

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

Treatment:

Other: Apple Juice

Other: Purple Grape Juice

Apple Juice First

Active Comparator group

Description:

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

Treatment:

Other: Apple Juice

Other: Purple Grape Juice