Vascular DilationPhase 1NCT05221905

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

A Phase 1 study testing BEET IT - Concentrate Beet root juice and BEET IT - Concentrate Beet root juice (nitrate depleted) in people with Vascular Dilation and Arterial Stiffness, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Vascular Dilation, Arterial Stiffness
What is being tested?: BEET IT - Concentrate Beet root juice and BEET IT - Concentrate Beet root juice (nitrate depleted)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2021to 1 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Student Health and Wellness Center
Charlottesville, Virginia, 22902

Other trials in United States

About this study

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.

Read the 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.

Conditions: Vascular Dilation, Arterial Stiffness
Being tested: BEET IT - Concentrate Beet root juice, BEET IT - Concentrate Beet root juice (nitrate depleted)
Keywords: Flow-mediated dilation, Pulse wave velocity, Exercise intensity, Vascular function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BEET IT - Concentrate Beet root juiceDrug
Also called Dietary Nitrate supplementation (nitrate rich)
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)Drug
Also called Dietary Nitrate supplementation (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.

Study groups in NCT05221905
Study group	Role	What they receive
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. Receives: Drug: BEET IT - Concentrate Beet root juice; Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)
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. Receives: Drug: BEET IT - Concentrate Beet root juice; Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)
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. Receives: Drug: BEET IT - Concentrate Beet root juice; Drug: BEET IT - Concentrate Beet root juice (nitrate depleted)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 90 minutes post-baseline.
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.
Measured: 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.
Measured: 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.
Measured: 180 minutes post-baseline.

Secondary outcomes (6)

Baseline Pulse Wave Velocity
Supine measures of carotid to femoral pulse wave velocity will be measured using a SphygmoCor Xcel device.
Measured: Baseline (minute 0).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 minutes post-baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20211 Apr 2023

First posted3 Feb 2022
Study start1 Nov 2021
Primary completion1 Apr 2023
Study completion1 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vascular DilationStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05221905
Sponsor's protocol ID: HSR210326
Status last verified: Nov 2023
First submitted: 14 Oct 2021
Last updated: 30 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Dilation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
ClinicalTrials.gov ID: NCT05221905
Acronym / sponsor ID: HSR210326
Conditions: Vascular Dilation, Arterial Stiffness
Keywords: Flow-mediated dilation, Pulse wave velocity, Exercise intensity, Vascular function
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Study start: 1 Nov 2021 (actual)
Primary completion: 1 Apr 2023 (actual)
Study completion: 1 Apr 2023 (actual)
First posted: 3 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing

Arm	Type	Receives
Acute High-Intensity Exercise	Active comparator	Drug: BEET IT - Concentrate Beet root juice, Drug: 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.
Acute Moderate-Intensity Exercise	Active comparator	Drug: BEET IT - Concentrate Beet root juice, Drug: 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.
Non-Exercise Control	Placebo comparator	Drug: BEET IT - Concentrate Beet root juice, Drug: 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.

Who may qualify

Ages: 45 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BEET IT - Concentrate Beet root juiceAlso: Dietary Nitrate supplementation (nitrate rich)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.	Drug	Acute High-Intensity Exercise, Acute Moderate-Intensity Exercise, Non-Exercise Control
BEET IT - Concentrate Beet root juice (nitrate depleted)Also: Dietary Nitrate supplementation (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.	Drug	Acute High-Intensity Exercise, Acute Moderate-Intensity Exercise, Non-Exercise Control

Primary outcome

Baseline Flow-Mediated Dilation
Time frame: 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 (60 minutes)
Time frame: 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 (90 minutes)
Time frame: 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.
Post-Exercise/Control Flow-Mediated Dilation (120 minutes)
Time frame: 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.
Post-Exercise/Control Flow-Mediated Dilation (150 min)
Time frame: 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 (180 min)
Time frame: 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.

6 secondary outcomes

Baseline Pulse Wave Velocity
Time frame: Baseline (minute 0).
Post-Exercise/Control Pulse Wave Velocity (60 min)
Time frame: 60 minutes post-baseline.
Post-Exercise/Control Pulse Wave Velocity (90 min)
Time frame: 90 minutes post-baseline.
Post-Exercise/Control Pulse Wave Velocity (120 min)
Time frame: 120 minutes post-baseline.
Post-Exercise/Control Pulse Wave Velocity (150 min)
Time frame: 150 minutes post-baseline.
Post-Exercise/Control Pulse Wave Velocity (180 min)
Time frame: 180 minutes post-baseline.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Individual participant dataSharing planned: Yes. 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.

Related trials for Vascular Dilation

RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Active, not recruitingEarly Phase 1
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arthur Weltman, PhD principal investigator

Professor of Kinesiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Flow-Mediated Dilation (time frame: Baseline (minute 0).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05221905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.