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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01043939
First received: January 5, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Other: Purple Grape Juice
Other: Apple Juice
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score) [ Time Frame: 4 weeks (change since baseline) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change in Oxidized LDL [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress

  • Change in Myeloperoxidase (MPO) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress

  • Change in High Sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation


Enrollment: 24
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Purple grape juice
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:
  • Apple juice
  • 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 Name: Purple grape juice
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:
  • Apple juice
  • clear 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.

  Eligibility

Ages Eligible for Study:   10 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043939

Locations
United States, Minnesota
Minnesota General Clinical Research Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Cindy K Blair, MPH Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01043939     History of Changes
Other Study ID Numbers: 2009NTLS074, NCI-2009-01497
Study First Received: January 5, 2010
Results First Received: December 4, 2011
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
childhood cancers
cardiovascular disease
childhood cancer survivor

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014