Phase 1 N=24 Randomized Treatment

Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT01043939 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score) — 0.06; 0.22 units on a scale — p=0.25

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Purple Grape Juice (Other); Apple Juice (Other)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Oct 2010

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

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.

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

View full record on ClinicalTrials.gov →

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.