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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Endothelial Dysfunction

Treatments: Dietary Supplement: Placebo; Drug: Climara; Drug: Placebo patch; Dietary Supplement: Resveratrol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02256540

R56HL114073 (U.S. NIH Grant/Contract)

14-0532

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups, including a placebo group

Placebo patch - placebo tablets

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Drug: Placebo patch

Placebo patch - Resveratrol tablets

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Resveratrol

Drug: Placebo patch

Climara patch - placebo tablets

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Drug: Climara