Trial Outcomes & Findings for The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women (NCT NCT02256540)
NCT ID: NCT02256540
Last Updated: 2020-03-20
Results Overview
Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Up to 2 hours post-exercise
Results posted on
2020-03-20
Participant Flow
Healthy women ages 50-70 years, at least 1 year beyond menopause and free of overt cardiovascular or chronic diseases.
7 participants did not qualify to participate in the study after consent/enrollment.
Participant milestones
| Measure |
Visit 1 Placebo - Visit 2 Estrogen - Visit 3 Resveratrol
Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.
Visit 2 Estrogen: Climara patch was worn two days prior to and during the exercise visit.
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.
Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.
|
Visit 1 Resveratrol - Visit 2 Placebo - Visit 3 Estrogen
Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.
Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.
Visit 3 Estrogen: Climara patch was worn two days prior to and during the exercise visit.
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.
|
Visit 1 Estrogen - Visit 2 Resveratrol - Visit 3 Placebo
Visit 1 Estrogen: Climara patch was worn two days prior to and during the exercise visit.
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.
Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.
Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Visit 1 Placebo - Visit 2 Estrogen - Visit 3 Resveratrol
Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.
Visit 2 Estrogen: Climara patch was worn two days prior to and during the exercise visit.
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.
Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.
|
Visit 1 Resveratrol - Visit 2 Placebo - Visit 3 Estrogen
Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.
Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.
Visit 3 Estrogen: Climara patch was worn two days prior to and during the exercise visit.
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.
|
Visit 1 Estrogen - Visit 2 Resveratrol - Visit 3 Placebo
Visit 1 Estrogen: Climara patch was worn two days prior to and during the exercise visit.
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.
Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.
Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Back pain preventing exercise
|
0
|
0
|
1
|
Baseline Characteristics
The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
|
|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 3.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hours post-exercisePopulation: Images were considered invalid and removed from analysis if the vascular boundaries were not able to be identified.
Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.
Outcome measures
| Measure |
Placebo Patch - Placebo Tablets
n=13 Participants
Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.
Placebo patch: Placebo patch designed to match active Climara patches.
Placebo: Placebo tablets designed to match active resveratrol tablets.
|
Placebo Patch - Resveratrol Tablets
n=12 Participants
Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.
Placebo patch: Placebo patch designed to match active Climara patches.
Resveratrol
|
Climara Patch - Placebo Tablets
n=12 Participants
Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.
Climara
Placebo: Placebo tablets designed to match active resveratrol tablets.
|
|---|---|---|---|
|
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
Baseline
|
4.11 Percent Change
Standard Error 0.44
|
6.93 Percent Change
Standard Error 0.79
|
5.86 Percent Change
Standard Error 0.65
|
|
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
30 min after exercise
|
3.20 Percent Change
Standard Error 0.45
|
5.88 Percent Change
Standard Error 0.81
|
5.41 Percent Change
Standard Error 0.67
|
|
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
60 min after exercise
|
3.23 Percent Change
Standard Error 0.44
|
7.01 Percent Change
Standard Error 0.79
|
6.99 Percent Change
Standard Error 0.69
|
|
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
120 min after exercise
|
4.35 Percent Change
Standard Error 0.44
|
7.57 Percent Change
Standard Error 0.81
|
8.03 Percent Change
Standard Error 0.65
|
SECONDARY outcome
Timeframe: baseline, 1-2 hours post-exercisePopulation: No data were collected for this outcome measure.
No gene and protein data were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 1-2 hrs post-exerciseMeasure of nitric oxide
Outcome measures
| Measure |
Placebo Patch - Placebo Tablets
n=15 Participants
Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.
Placebo patch: Placebo patch designed to match active Climara patches.
Placebo: Placebo tablets designed to match active resveratrol tablets.
|
Placebo Patch - Resveratrol Tablets
n=15 Participants
Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.
Placebo patch: Placebo patch designed to match active Climara patches.
Resveratrol
|
Climara Patch - Placebo Tablets
n=15 Participants
Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.
Climara
Placebo: Placebo tablets designed to match active resveratrol tablets.
|
|---|---|---|---|
|
Change in Nitrate/Nitrite Levels
Baseline
|
121.3 micromolar
Standard Deviation 57.6
|
134.2 micromolar
Standard Deviation 65.6
|
110.9 micromolar
Standard Deviation 53.5
|
|
Change in Nitrate/Nitrite Levels
60 min after exercise
|
108.6 micromolar
Standard Deviation 48.5
|
109.6 micromolar
Standard Deviation 59.2
|
118.2 micromolar
Standard Deviation 61.1
|
|
Change in Nitrate/Nitrite Levels
120 min after exercise
|
114.7 micromolar
Standard Deviation 54.2
|
118.7 micromolar
Standard Deviation 56.0
|
111.1 micromolar
Standard Deviation 60.6
|
Adverse Events
Placebo Patch - Placebo Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Patch - Resveratrol Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Climara Patch - Placebo Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kerrie Moreau
University of Colorado Anschutz Medical Campus
Phone: 303-724-1914
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place