Clinical trial NCT02256540: The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
Official title: The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-10-03
Enrollment: 25
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
timeFrame: Up to 2 hours post-exercise
Secondary outcomes:
measure: Gene and Protein Expression in Peripheral Blood Mononuclear Cells
timeFrame: baseline, 1-2 hours post-exercise
measure: Change in Nitrate/Nitrite Levels
timeFrame: baseline, 1-2 hrs post-exercise
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Kerrie L Moreau, PhD
role: PRINCIPAL_INVESTIGATOR
References: