Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors (JAVA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Cindy Blair, Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT01043939

First received: January 5, 2010

Last updated: October 29, 2012

Last verified: October 2012

History of Changes

Results First Received: December 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cardiovascular Disease
Interventions:	Other: Purple Grape Juice Other: Apple Juice

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the Metabolic Syndrome Study in Childhood Cancer Survivors and the Long-Term Follow-up Clinic, both at the University of Minnesota, Minneapolis, MN between October 2009 and May 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 recruited; 6 drop-outs during 4 week run-in period, prior to randomization due to now-show for first clinic visit or concerns regarding time, compliance, or blood draws.

Reporting Groups

	Description
Arm 1 Purple Grape Juice Then Apple Juice	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 2 Apple Juice Then Purple Grape 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).

Participant Flow for 3 periods

Period 1: First Intervention

	Arm 1 Purple Grape Juice Then Apple Juice	Arm 2 Apple Juice Then Purple Grape Juice
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Period 2: Washout Period

	Arm 1 Purple Grape Juice Then Apple Juice	Arm 2 Apple Juice Then Purple Grape Juice
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Period 3: Second Intervention

	Arm 1 Purple Grape Juice Then Apple Juice	Arm 2 Apple Juice Then Purple Grape Juice
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes groups randomized to receive purple grape juice first and apple juice first

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	24
Age [units: participants]
<=18 years	19
Between 18 and 65 years	5
>=65 years	0
Age [units: years] Mean ± Standard Deviation	15.8 ± 2.6
Gender [units: participants]
Female	7
Male	17
Region of Enrollment [units: participants]
United States	24
Weight ^[1] [units: kilograms] Mean ± Standard Deviation	60 ± 13.8
Height ^[2] [units: Centimeters] Mean ± Standard Deviation	165 ± 11.6
Body Mass Index ^[3] [units: kg/m^2] Mean ± Standard Deviation	22 ± 3.2
Systolic blood pressure [units: mmHg] Mean ± Standard Deviation	111 ± 9.6
Diastolic blood pressure [units: mmHg] Mean ± Standard Deviation	59 ± 8.3
Fasting glucose [units: mg/dL] Mean ± Standard Deviation	78 ± 7.0
Fasting insulin [units: mU/L] Mean ± Standard Deviation	6.3 ± 4.7
Low-density lipoprotein (LDL) Cholesterol [units: mg/dL] Mean ± Standard Deviation	95 ± 20.1
High-density lipoprotein (HDL) Cholesterol [units: mg/dL] Mean ± Standard Deviation	50 ± 10.9
Triglycerides [units: mg/dL] Mean ± Standard Deviation	78 ± 33.7

[1]	Measured in kilograms at beginning of study.
[2]	Measured in centimeters are beginning of study.
[3]	Measured in kilograms/m^2 at beginning of study.

Outcome Measures

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1. Primary:

Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score) [ Time Frame: 4 weeks (change since baseline) ]

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2. Secondary:

Change in Oxidized LDL [ Time Frame: 4 weeks ]

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3. Secondary:

Change in Myeloperoxidase (MPO) [ Time Frame: 4 weeks ]

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4. Secondary:

Change in High Sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Cindy K. Blair, MPH
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-624-9668
e-mail: blair016@umn.edu

No publications provided

Responsible Party:	Cindy Blair, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT01043939 History of Changes
Other Study ID Numbers:	2009NTLS074, NCI-2009-01497
Study First Received:	January 5, 2010
Results First Received:	December 4, 2011
Last Updated:	October 29, 2012
Health Authority:	United States: Institutional Review Board

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