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

NCT ID: NCT02256540

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-03-25

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.

Conditions

Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo patch

Intervention Type: DRUG

Placebo patch designed to match active Climara patches.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablets designed to match active resveratrol tablets.

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.

Group Type: EXPERIMENTAL

Placebo patch

Intervention Type: DRUG

Placebo patch designed to match active Climara patches.

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: ACTIVE_COMPARATOR

Climara

Intervention Type: DRUG

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablets designed to match active resveratrol tablets.

Interventions

Climara

Intervention Type: DRUG

Placebo patch

Placebo patch designed to match active Climara patches.

Intervention Type: DRUG

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo tablets designed to match active resveratrol tablets.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Estradiol transdermal patch

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerrie L Moreau, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

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R56HL114073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-0532

Identifier Type: -

Identifier Source: org_study_id