Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
- Conditions
- Vascular DilationArterial Stiffness
- Interventions
- Registration Number
- NCT05221905
- Lead Sponsor
- University of Virginia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acute Moderate-Intensity Exercise BEET IT - Concentrate Beet root juice (nitrate depleted) 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. Acute High-Intensity Exercise BEET IT - Concentrate Beet root juice 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. Acute Moderate-Intensity Exercise BEET IT - Concentrate Beet root juice 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. Non-Exercise Control BEET IT - Concentrate Beet root juice (nitrate depleted) 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. Non-Exercise Control BEET IT - Concentrate Beet root juice 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. Acute High-Intensity Exercise BEET IT - Concentrate Beet root juice (nitrate depleted) 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.
- Primary Outcome Measures
Name Time Method Post-Exercise/Control Flow-Mediated Dilation (90 minutes) 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 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) 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) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Baseline Pulse Wave Velocity Baseline (minute 0). Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (60 min) 60 minutes post-baseline. Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (120 min) 120 minutes post-baseline. Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (150 min) 150 minutes post-baseline. Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (90 min) 90 minutes post-baseline. Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Post-Exercise/Control Pulse Wave Velocity (180 min) 180 minutes post-baseline. Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Trial Locations
- Locations (1)
Student Health and Wellness Center
🇺🇸Charlottesville, Virginia, United States