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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute High-Intensity Exercise | Active Comparator | 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. |
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| Acute Moderate-Intensity Exercise | Active Comparator | 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. |
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| Non-Exercise Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEET IT - Concentrate Beet root juice | Drug | Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (~6.5 mmol) will be consumed twice daily (totalling ~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Flow-Mediated Dilation | 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 (minute 0). |
| Post-Exercise/Control Flow-Mediated Dilation (60 minutes) | 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. | 60 minutes post-baseline. |
| Post-Exercise/Control Flow-Mediated Dilation (90 minutes) | 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. | 90 minutes post-baseline. |
| Post-Exercise/Control Flow-Mediated Dilation (120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Pulse Wave Velocity | Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device. | Baseline (minute 0). |
| Post-Exercise/Control Pulse Wave Velocity (60 min) |
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Inclusion Criteria:
Exclusion Criteria:
All subjects are post-menopausal females.
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Weltman, PhD | Professor of Kinesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Student Health and Wellness Center | Charlottesville | Virginia | 22902 | United States |
Microsoft excel sheets, Graphpad Prism files, Informed Consent, and Study Protocol forms will be available upon reasonable request. All identifiable data de-identified on 24 participants will be available.
De-identified data will be shared upon reasonable request for 3 years after study completion
Email Austin Hogwood at ach2jb@virginia.edu for any requests.
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Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing
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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.
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| BEET IT - Concentrate Beet root juice (nitrate depleted) | Drug | Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (~0 mmol) will be consumed twice daily (totalling ~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted. |
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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. |
| 120 minutes post-baseline. |
| Post-Exercise/Control Flow-Mediated Dilation (150 min) | 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. | 150 minutes post-baseline. |
| Post-Exercise/Control Flow-Mediated Dilation (180 min) | 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. | 180 minutes post-baseline. |
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
| 60 minutes post-baseline. |
| Post-Exercise/Control Pulse Wave Velocity (90 min) | Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device. | 90 minutes post-baseline. |
| Post-Exercise/Control Pulse Wave Velocity (120 min) | Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device. | 120 minutes post-baseline. |
| Post-Exercise/Control Pulse Wave Velocity (150 min) | Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device. | 150 minutes post-baseline. |
| Post-Exercise/Control Pulse Wave Velocity (180 min) | Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device. | 180 minutes post-baseline. |