ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02256540
Recruitment Status : Active, not recruiting
First Posted : October 3, 2014
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Drug: Climara Drug: Placebo patch Dietary Supplement: Resveratrol Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
Study Start Date : August 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Placebo Comparator: 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.
Drug: Placebo patch
Placebo patch designed to match active Climara patches.

Dietary Supplement: Placebo
Placebo tablets designed to match active resveratrol tablets.

Experimental: 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.
Drug: Placebo patch
Placebo patch designed to match active Climara patches.

Dietary Supplement: Resveratrol
Active Comparator: 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.
Drug: Climara
Other Name: Estradiol transdermal patch

Dietary Supplement: Placebo
Placebo tablets designed to match active resveratrol tablets.




Primary Outcome Measures :
  1. Change in brachial artery flow-mediated dilation [ Time Frame: Up to 2 hours post-exercise ]

Secondary Outcome Measures :
  1. Gene and protein expression in peripheral blood mononuclear cells [ Time Frame: baseline, 1-2 hours post-exercise ]
  2. Change in Nitrate/Nitrite levels [ Time Frame: baseline, 1-2 hrs post-exercise ]
    Measure of nitric oxide



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256540


Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Kerrie L Moreau, PhD University of Colorado School of Medicine

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02256540     History of Changes
Other Study ID Numbers: 14-0532
UL1TR001082 ( U.S. NIH Grant/Contract )
R56HL114073 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Resveratrol
Platelet Aggregation Inhibitors
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female