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

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256540
• Other study ID #: 14-0532
• Secondary ID: UL1TR001082R56HL
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: March 25, 2016

Study information

• Verified date: March 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 25, 2016
• Est. primary completion date: March 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Drug:
• Climara

• Placebo patch
Placebo patch designed to match active Climara patches.

Dietary Supplement:
• Resveratrol

• Placebo
Placebo tablets designed to match active resveratrol tablets.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 hours post-exercise
Secondary	Gene and Protein Expression in Peripheral Blood Mononuclear Cells	No gene and protein data were analyzed.	baseline, 1-2 hours post-exercise
Secondary	Change in Nitrate/Nitrite Levels	Measure of nitric oxide	baseline, 1-2 hrs post-exercise