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NCT05221905 · ClinicalTrials.gov registry record · Phase 1
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
A Phase 1 study of Arterial Stiffness and Vascular Dilation, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05221905: Completed Phase 1 study of Arterial Stiffness and Vascular Dilation, sponsored by University of Virginia.
NCT05221905 is a Phase 1 study of Arterial Stiffness and Vascular Dilation that has completed, run by University of Virginia. The registered enrollment target is 24 participants, below the 121-participant average among 12 other Arterial Stiffness trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05221905, a Phase 1 study of Arterial Stiffness and Vascular Dilation, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 so
Conditions Studied
Interventions
- DRUG BEET IT - Concentrate Beet root juice
- DRUG BEET IT - Concentrate Beet root juice (nitrate depleted)
Study Locations (1)
Virginia
- Student Health and Wellness Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-04-01 |
| Phase | Phase 1 |
What the finished NCT05221905 record still lists
NCT05221905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 121-participant average among 12 other Arterial Stiffness trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Arterial Stiffness appearing as the primary indexed condition, and to 2 interventions - of which BEET IT - Concentrate Beet root juice is the first listed.
NCT05221905 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05221905 about?
NCT05221905 is a clinical study titled "Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females". 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 supplementati...
What is the current status of trial NCT05221905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-11-01. Estimated completion is 2023-04-01.
What conditions does trial NCT05221905 study?
This clinical trial studies the following conditions: Arterial Stiffness, Vascular Dilation.
What interventions are being tested in trial NCT05221905?
The interventions under investigation include: BEET IT - Concentrate Beet root juice (DRUG), BEET IT - Concentrate Beet root juice (nitrate depleted) (DRUG).
Who is sponsoring clinical trial NCT05221905?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05221905 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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