Trial Outcomes & Findings for Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors (NCT NCT01043939)
NCT ID: NCT01043939
Last Updated: 2014-12-31
Results Overview
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.
COMPLETED
PHASE1
24 participants
4 weeks (change since baseline)
2014-12-31
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
12
|
12
|
|
Washout Period
COMPLETED
|
12
|
12
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
12
|
|
Second Intervention
COMPLETED
|
12
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
Includes groups randomized to receive purple grape juice first and apple juice first
|
|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.8 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Weight
|
60 kilograms
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Height
|
165 Centimeters
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Body Mass Index
|
22 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Systolic blood pressure
|
111 mmHg
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Diastolic blood pressure
|
59 mmHg
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Fasting glucose
|
78 mg/dL
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Fasting insulin
|
6.3 mU/L
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Low-density lipoprotein (LDL) Cholesterol
|
95 mg/dL
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
High-density lipoprotein (HDL) Cholesterol
|
50 mg/dL
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Triglycerides
|
78 mg/dL
STANDARD_DEVIATION 33.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (change since baseline)Population: Intent-to-Treat analysis
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 measures
| Measure |
Purple Grape Juice
n=24 Participants
6 ounces of grape juice consumed twice daily in either the first or second intervention period
|
Apple Juice
n=24 Participants
6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
|
|---|---|---|
|
Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)
|
0.06 units on a scale
Standard Error 0.089 • Interval -0.42 to 0.11
|
0.22 units on a scale
Standard Error 0.093 • Interval -0.42 to 0.22
|
SECONDARY outcome
Timeframe: 4 weeksChange from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress
Outcome measures
| Measure |
Purple Grape Juice
n=24 Participants
6 ounces of grape juice consumed twice daily in either the first or second intervention period
|
Apple Juice
n=24 Participants
6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
|
|---|---|---|
|
Change in Oxidized LDL
|
4.66 Units/Liter
Standard Error 2.02
|
1.57 Units/Liter
Standard Error 2.03
|
SECONDARY outcome
Timeframe: 4 weeksChange from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress
Outcome measures
| Measure |
Purple Grape Juice
n=24 Participants
6 ounces of grape juice consumed twice daily in either the first or second intervention period
|
Apple Juice
n=24 Participants
6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
|
|---|---|---|
|
Change in Myeloperoxidase (MPO)
|
0.95 ng/mL
Interval 0.78 to 1.16
|
1.03 ng/mL
Interval 0.84 to 1.26
|
SECONDARY outcome
Timeframe: 4 weeksChange from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation
Outcome measures
| Measure |
Purple Grape Juice
n=24 Participants
6 ounces of grape juice consumed twice daily in either the first or second intervention period
|
Apple Juice
n=24 Participants
6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
|
|---|---|---|
|
Change in High Sensitivity C-Reactive Protein (Hs-CRP)
|
1.42 mg/L
Interval 0.84 to 2.41
|
1.06 mg/L
Interval 0.62 to 1.8
|
Adverse Events
Purple Grape Juice
Apple Juice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cindy K. Blair, MPH
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place