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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Other: Purple Grape Juice; Other: Apple Juice

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Minnesota General Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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; 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; Other Names: clear apple juice
Active Comparator: 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	Other: 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; 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; Other Names: clear apple juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Cindy K Blair, MPH, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: cardiovascular disease; childhood cancers; childhood cancer survivor
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2009NTLS074; NCI-2009-01497 (Registry Identifier: National Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No