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Completed

NCT Number: NCT02256540

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

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.

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Key information

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Climara

Drug

Other names: Estradiol transdermal patch

Placebo Patch

Drug

Placebo patch designed to match active Climara patches.

Resveratrol

Dietary Supplement

Placebo

Dietary Supplement

Placebo tablets designed to match active resveratrol tablets.

Primary outcomes

  1. 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

  1. Gene and Protein Expression in Peripheral Blood Mononuclear Cells

    Time frame: baseline, 1-2 hours post-exercise

    No gene and protein data were analyzed.

  2. Change in Nitrate/Nitrite Levels

    Time frame: baseline, 1-2 hrs post-exercise

    Measure of nitric oxide

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2014
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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