Phase 1
Completed N=24
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
Source: ClinicalTrials.gov NCT01043939 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score) — 0.06; 0.22 units on a scale — p=0.25
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score) |
0.06; 0.22 | 0.25 |
| SECONDARY Change in Oxidized LDL |
4.66; 1.57 | 0.29 |
| SECONDARY Change in Myeloperoxidase (MPO) |
0.95; 1.03 | 0.15 |
| SECONDARY Change in High Sensitivity C-Reactive Protein (Hs-CRP) |
1.42; 1.06 | 0.37 |
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
Data sourced from ClinicalTrials.gov (NCT01043939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.