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


Phase 1
10 Years
30 Years
Not Enrolling
Both
Cardiovascular Disease

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)

Outcome Description:

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.

Outcome Time Frame:

4 weeks (change since baseline)

Safety Issue:

No

Principal Investigator

Cindy K Blair, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2009NTLS074

NCT ID:

NCT01043939

Start Date:

November 2009

Completion Date:

December 2010

Related Keywords:

  • Cardiovascular Disease
  • childhood cancers
  • cardiovascular disease
  • childhood cancer survivor
  • Cardiovascular Diseases

Name

Location

Minnesota General Clinical Research CenterMinneapolis, Minnesota  55455