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Clinical Trials/NCT02256540
NCT02256540
Completed
Not Applicable

The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women

University of Colorado, Denver1 site in 1 country25 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Placebo patch
Conditions
Endothelial Dysfunction
Sponsor
University of Colorado, Denver
Enrollment
25
Locations
1
Primary Endpoint
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
Status
Completed
Last Updated
6 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
March 25, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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);
  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Placebo patch - placebo tablets

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.

Intervention: Placebo patch

Placebo patch - placebo tablets

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.

Intervention: Placebo

Placebo patch - Resveratrol tablets

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.

Intervention: Placebo patch

Placebo patch - Resveratrol tablets

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.

Intervention: Resveratrol

Climara patch - placebo tablets

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.

Intervention: Climara

Climara patch - placebo tablets

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.

Intervention: Placebo

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Gene and Protein Expression in Peripheral Blood Mononuclear Cells(baseline, 1-2 hours post-exercise)
  • Change in Nitrate/Nitrite Levels(baseline, 1-2 hrs post-exercise)

Study Sites (1)

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