Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

Cardiovascular Disease Clinical Trial

— JAVA  

Official title:

A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043939
• Other study ID #: 2009NTLS074
• Secondary ID: NCI-2009-01497
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2010
• Last updated: December 9, 2014
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Purple Grape Juice
6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
• Apple Juice
6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Locations

Country	Name	City	State
United States	Minnesota General Clinical Research Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change in Oxidized LDL	Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress	4 weeks	No
Secondary	Change in Myeloperoxidase (MPO)	Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress	4 weeks	No
Secondary	Change in High Sensitivity C-Reactive Protein (Hs-CRP)	Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation	4 weeks	No