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

NCT02256540 | Completed Results

• 3 other identifiers: 14-0532UL1TR001082R56HL114073
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gene and Protein Expression in Peripheral Blood Mononuclear Cells

  baseline, 1-2 hours post-exercise

• Change in Nitrate/Nitrite Levels

  baseline, 1-2 hrs post-exercise

Study Arms (3)

Placebo patch - placebo tablets

PLACEBO COMPARATOR

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.

Drug: Placebo patch; Dietary Supplement: Placebo

Placebo patch - Resveratrol tablets

EXPERIMENTAL

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.

Drug: Placebo patch; Dietary Supplement: Resveratrol

Climara patch - placebo tablets

ACTIVE COMPARATOR

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.

Drug: Climara; Dietary Supplement: Placebo

Interventions

Climara DRUG

Also known as: Estradiol transdermal patch

Climara patch - placebo tablets

Placebo patch DRUG

Placebo patch designed to match active Climara patches.

Placebo patch - Resveratrol tablets; Placebo patch - placebo tablets

Resveratrol DIETARY_SUPPLEMENT

Placebo patch - Resveratrol tablets

Placebo DIETARY_SUPPLEMENT

Placebo tablets designed to match active resveratrol tablets.

Climara patch - placebo tablets; Placebo patch - placebo tablets

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Estradiol; Resveratrol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Results Point of Contact

• Title: Dr. Kerrie Moreau
• Organization: University of Colorado Anschutz Medical Campus

kerrie.moreau@cuanschutz.edu

303-724-1914

Study Officials

• Kerrie L Moreau, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: August 1, 2014
• Primary Completion: March 25, 2016
• Study Completion: March 25, 2016
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Locations

US (1)