Clinical trial NCT01043939: Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
Official title: A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: childhood cancers
cardiovascular disease
childhood cancer survivor
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)
timeFrame: 4 weeks (change since baseline)
Secondary outcomes:
measure: Change in Oxidized LDL
timeFrame: 4 weeks
measure: Change in Myeloperoxidase (MPO)
timeFrame: 4 weeks
measure: Change in High Sensitivity C-Reactive Protein (Hs-CRP)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minnesota General Clinical Research Center
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Cindy K Blair, MPH
role: PRINCIPAL_INVESTIGATOR
References: