Endothelial DysfunctionNCT02256540
The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
A study testing Climara and Resveratrol in people with Endothelial Dysfunction, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This pilot study plans to learn more about the aging of blood vessels and arteries in women. As women age and go through menopause, their risk for cardiovascular disease increases. Also with aging and menopause, levels of the reproductive hormone estradiol decline. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Climara and Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 25 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 50-70 and at least 1 year beyond menopause;
- resting blood pressure <140/90 mmHg;
- plasma glucose concentrations <110 mg/dL under fasting conditions;
- BMI < 35;
- LDL cholesterol < 160 mg/dL;
- sedentary or recreationally active (<3 days of vigorous aerobic exercise);
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- no use of OCs, HT, or other medications that might influence cardiovascular function;
- nonsmokers;
- no use of vitamin supplements, blood thinners or NSAIDS, or willing to stop use one month prior to and for the duration of the study;
- not taking any other medications that would interact with E2 patch or resveratrol to confound interpretation of results.
Who cannot join
- history of or active E2-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia (≥ 150 mg/dL), and CVD;
- known allergy to transdermal patch, or resveratrol;
- history of stomach ulcer or bleeding;
- other contraindications to HT or resveratrol.
- other conditions for which individuals will be excluded from the study include: diabetes, active infection, history of seizures or disease that affects the nervous system or an abnormal resting ECG.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
This pilot study plans to learn more about the aging of blood vessels and arteries in women. As women age and go through menopause, their risk for cardiovascular disease increases. Also with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone replacement therapy to restore estradiol levels does not protect women from cardiovascular disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease risk. However, there are differences between men and women in their response to exercise. In older men, exercise improves the health of their arteries, but in postmenopausal women, exercise does not provide this benefit. The purpose of this pilot study is to determine whether low estradiol levels in postmenopausal women are responsible for the poor vascular response to exercise. In this study the investigators will also test whether treatment with resveratrol, a plant compound found in red wine, improves postmenopausal women's response to exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol will improve vascular responses to an acute bout of exercise.
- Conditions
- Endothelial Dysfunction
- Being tested
- Climara, Placebo patch, Resveratrol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClimaraDrug
Also called Estradiol transdermal patch
Placebo patchDrug
Placebo patch designed to match active Climara patches.
ResveratrolDietary supplement
PlaceboDietary supplement
Placebo tablets designed to match active resveratrol tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo patch - placebo tablets | Placebo comparator | 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. Receives: Drug: Placebo patch; Dietary Supplement: Placebo |
| Placebo patch - Resveratrol tablets | Experimental | 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. Receives: Drug: Placebo patch; Dietary Supplement: Resveratrol |
| Climara patch - placebo tablets | Active comparator | 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. Receives: Drug: Climara; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.
Measured: Up to 2 hours post-exercise
Secondary outcomes (2)
Gene and Protein Expression in Peripheral Blood Mononuclear Cells
No gene and protein data were analyzed.
Measured: baseline, 1-2 hours post-exercise
Change in Nitrate/Nitrite Levels
Measure of nitric oxide
Measured: baseline, 1-2 hrs post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startAug 2014
- Primary completion25 Mar 2016
- Study completion25 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kerrie L Moreau, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256540
- Sponsor's protocol ID
- 14-0532
- Other IDs
- UL1TR001082, R56HL114073
- Status last verified
- Mar 2020
- First submitted
- 1 Oct 2014
- Last updated
- 20 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02256540
- Acronym / sponsor ID
- 14-0532
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2014
- Primary completion
- 25 Mar 2016 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Posted 20 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study plans to learn more about the aging of blood vessels and arteries in women. As women age and go through menopause, their risk for cardiovascular disease increases. Also with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone replacement therapy to restore estradiol levels does not protect women from cardiovascular disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease risk. However, there are differences between men and women in their response to exercise. In older men, exercise improves the health of their arteries, but in postmenopausal women, exercise does not provide this benefit. The purpose of this pilot study is to determine whether low estradiol levels in postmenopausal women are responsible for the poor vascular response to exercise. In this study the investigators will also test whether treatment with resveratrol, a plant compound found in red wine, improves postmenopausal women's response to exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol will improve vascular responses to an acute bout of exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo patch - placebo tablets | Placebo comparator | Drug: Placebo patch, Dietary Supplement: PlaceboPostmenopausal 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 - Resveratrol tablets | Experimental | Drug: Placebo patch, Dietary Supplement: ResveratrolPostmenopausal 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. |
| Climara patch - placebo tablets | Active comparator | Drug: Climara, Dietary Supplement: PlaceboPostmenopausal 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between the ages of 50-70 and at least 1 year beyond menopause;
- resting blood pressure <140/90 mmHg;
- plasma glucose concentrations <110 mg/dL under fasting conditions;
- BMI < 35;
- LDL cholesterol < 160 mg/dL;
Key exclusion criteria (5 listed)
- history of or active E2-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia (≥ 150 mg/dL), and CVD;
- known allergy to transdermal patch, or resveratrol;
- history of stomach ulcer or bleeding;
- other contraindications to HT or resveratrol.
- other conditions for which individuals will be excluded from the study include: diabetes, active infection, history of seizures or disease that affects the nervous system or an abnormal resting ECG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClimaraAlso: Estradiol transdermal patch | Drug | Climara patch - placebo tablets |
| Placebo patchPlacebo patch designed to match active Climara patches. | Drug | Placebo patch - Resveratrol tablets, Placebo patch - placebo tablets |
| Resveratrol | Dietary supplement | Placebo patch - Resveratrol tablets |
| PlaceboPlacebo tablets designed to match active resveratrol tablets. | Dietary supplement | Climara patch - placebo tablets, Placebo patch - placebo tablets |
Primary outcome
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
Time frame: Up to 2 hours post-exercise
Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.
2 secondary outcomes
Gene and Protein Expression in Peripheral Blood Mononuclear Cells
Time frame: baseline, 1-2 hours post-exercise
Change in Nitrate/Nitrite Levels
Time frame: baseline, 1-2 hrs post-exercise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerrie L Moreau, PhD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Climara and Resveratrol in people with Endothelial Dysfunction, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point (time frame: Up to 2 hours post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.