A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors
- To evaluate the effect of PGJ on endothelial function, a key measure of vascular health
and considered a barometer for cardiovascular disease risk.
- To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Cindy K Blair, MPH
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
|Minnesota General Clinical Research Center||Minneapolis, Minnesota 55455|