The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo patch (Drug)
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.
干预措施: Placebo (Dietary Supplement)
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.
干预措施: Placebo patch (Drug)
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.
干预措施: Resveratrol (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.
干预措施: Climara (Drug)
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.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
时间窗: Up to 2 hours post-exercise
Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.
次要结局
- 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)