Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females

Arterial Stiffness Clinical Trial

Official title:

Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221905
• Other study ID #: HSR210326
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arterial Stiffness
• Vascular Dilation

Intervention

Drug:
• BEET IT - Concentrate Beet root juice
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.
• BEET IT - Concentrate Beet root juice (nitrate depleted)
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.

Locations

Country	Name	City	State
United States	Student Health and Wellness Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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.
Primary	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.
Primary	Post-Exercise/Control Flow-Mediated Dilation (120 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.	120 minutes post-baseline.
Primary	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.
Primary	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.
Secondary	Baseline Pulse Wave Velocity	Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.	Baseline (minute 0).
Secondary	Post-Exercise/Control Pulse Wave Velocity (60 min)	Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.	60 minutes post-baseline.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.