Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

NCT01043939 | Completed Phase 1 Results DMC

• 2 other identifiers: 2009NTLS074NCI-2009-01497
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

childhood cancers; cardiovascular disease; childhood cancer survivor

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Change in Oxidized LDL

  4 weeks

• Change in Myeloperoxidase (MPO)

  4 weeks

• Change in High Sensitivity C-Reactive Protein (Hs-CRP)

  4 weeks

Study Arms (2)

Purple Grape Juice First

ACTIVE COMPARATOR

After 4 week run-in period, drink 6 ounces of purple grape juice twice daily, then 4 week washout, week 12 drink 6 ounces of clear apple juice for 4 weeks twice daily

Other: Purple Grape Juice; Other: Apple Juice

Apple Juice First

ACTIVE COMPARATOR

After 4 week run-in period, drink 6 ounces of clear apple juice twice daily, then 4 week washout, week 12 drink 6 ounces of purple grape juice for 4 weeks twice daily

Other: Purple Grape Juice; Other: Apple Juice

Interventions

Purple Grape Juice OTHER

6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Apple Juice First; Purple Grape Juice First

Apple Juice OTHER

6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Also known as: clear apple juice

Apple Juice First; Purple Grape Juice First

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Minnesota General Clinical Research Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Cindy K. Blair, MPH
• Organization: Masonic Cancer Center, University of Minnesota

blair016@umn.edu

612-624-9668

Study Officials

• Cindy K Blair, MPH

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 31, 2014
• Results First Posted: November 29, 2012

Record last verified: 2014-12

Locations

US (1)