A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- University of Minnesota
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
- Change in High Sensitivity C-Reactive Protein (Hs-CRP)(4 weeks)
- Change in Oxidized LDL(4 weeks)
- Change in Myeloperoxidase (MPO)(4 weeks)