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Completed

NCT Number: NCT01043939

Purple Grape Juice in Improving Vascular Health in 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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Minnesota General Clinical Research Center

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Purple Grape Juice

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

Other

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

Primary outcomes

  1. Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)

    Time frame: 4 weeks (change since baseline)

    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 outcomes

  1. Change in Oxidized LDL

    Time frame: 4 weeks

    Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress

  2. Change in Myeloperoxidase (MPO)

    Time frame: 4 weeks

    Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress

  3. Change in High Sensitivity C-Reactive Protein (Hs-CRP)

    Time frame: 4 weeks

    Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors

Acronym: JAVA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2010
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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