Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Post-Exercise/Control Flow-Mediated Dilation (90 minutes)
研究概览
简要总结
Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.
详细描述
The purpose of this study is to determine whether acute inorganic nitrate supplementation and exercising at different exercise intensities (high vs moderate) improve vascular health in post-menopausal females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blind study, where neither the investigators nor the subjects will know whether the participants are receiving the active supplement or placebo supplement until study conclusion.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year
- •Greater than age 45 but less than age 75
- •Sedentary (does not exercise regularly)
- •No major changes in medication in the last 3 months
排除标准
- •Smokers within last 5 years
- •Weight unstable (loss/gain of more than 3kg in the past 3 months)
- •Any medical condition that prevents the subject from exercising safely
- •Hormone replacement therapy (current or within last 3 months)
- •Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
- •Hysterectomy or oophorectomy
研究组 & 干预措施
Acute High-Intensity Exercise
Subjects will exercise at an intensity of 75% of the difference between the lactate threshold and VO2peak until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.
干预措施: BEET IT - Concentrate Beet root juice (Drug)
Acute High-Intensity Exercise
Subjects will exercise at an intensity of 75% of the difference between the lactate threshold and VO2peak until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.
干预措施: BEET IT - Concentrate Beet root juice (nitrate depleted) (Drug)
Acute Moderate-Intensity Exercise
Subjects will exercise at an intensity at the lactate threshold until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.
干预措施: BEET IT - Concentrate Beet root juice (Drug)
Acute Moderate-Intensity Exercise
Subjects will exercise at an intensity at the lactate threshold until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.
干预措施: BEET IT - Concentrate Beet root juice (nitrate depleted) (Drug)
Non-Exercise Control
Measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, without exercise taking place during time points 0-60 min.
干预措施: BEET IT - Concentrate Beet root juice (Drug)
Non-Exercise Control
Measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, without exercise taking place during time points 0-60 min.
干预措施: BEET IT - Concentrate Beet root juice (nitrate depleted) (Drug)
结局指标
主要结局
Post-Exercise/Control Flow-Mediated Dilation (90 minutes)
时间窗: 90 minutes post-baseline.
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.
Baseline Flow-Mediated Dilation
时间窗: Baseline (minute 0).
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.
Post-Exercise/Control Flow-Mediated Dilation (180 min)
时间窗: 180 minutes post-baseline.
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.
Post-Exercise/Control Flow-Mediated Dilation (60 minutes)
时间窗: 60 minutes post-baseline.
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.
Post-Exercise/Control Flow-Mediated Dilation (150 min)
时间窗: 150 minutes post-baseline.
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.
Post-Exercise/Control Flow-Mediated Dilation (120 minutes)
时间窗: 120 minutes post-baseline.
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution doppler ultrasound utilizing a 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle. Images will be analyzed offline using specialized software (Medical Imaging Applications, Inc.) to calculate the change in brachial artery diameter.
次要结局
- Baseline Pulse Wave Velocity(Baseline (minute 0).)
- Post-Exercise/Control Pulse Wave Velocity (60 min)(60 minutes post-baseline.)
- Post-Exercise/Control Pulse Wave Velocity (120 min)(120 minutes post-baseline.)
- Post-Exercise/Control Pulse Wave Velocity (150 min)(150 minutes post-baseline.)
- Post-Exercise/Control Pulse Wave Velocity (90 min)(90 minutes post-baseline.)
- Post-Exercise/Control Pulse Wave Velocity (180 min)(180 minutes post-baseline.)
研究者
Arthur L Weltman
Professor
University of Virginia