Herbal and Botanical

All Drugs and Chemicals

Grape

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

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

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

Purple Grape Juice

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

Apple Juice

Cindy K Blair, MPH

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.

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.

Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

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

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.

Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress

Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress

Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation

University of Minnesota

6 ounces of grape juice consumed twice daily in either the first or second intervention period

6 ounces of clear apple juice consumed twice daily in either the first or second intervention period

Includes groups randomized to receive purple grape juice first and apple juice first

Entire Study Population

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Measured in kilograms at beginning of study.

Weight

Measured in centimeters are beginning of study.

Height

Measured in kilograms/m\^2 at beginning of study.

Body Mass Index

Systolic blood pressure

Diastolic blood pressure

Fasting glucose

Fasting insulin

Low-density lipoprotein (LDL) Cholesterol

High-density lipoprotein (HDL) Cholesterol

Triglycerides

Cindy K. Blair, MPH

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

Change in Oxidized LDL

Arm 2 Apple Juice Then Purple Grape Juice

Change in Myeloperoxidase (MPO)

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

Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).

Arm 1 Purple Grape Juice Then Apple Juice

Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors	NCT01043939	Cardiovascular ...	Purple Grape Ju... Apple Juice	10 Years - 30 Years	University of Minnesota
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors	NCT01043939	Cardiovascular ...	Purple Grape Ju... Apple Juice	10 Years - 30 Years	University of Minnesota

Spots Global Cancer Trial Database for purple grape juice