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NCT05595915 · ClinicalTrials.gov registry record · Phase 1
COMP-4 Supplementation and Brachial Artery FMD
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05595915 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 32 participants.
The verdict
NCT05595915, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
In a young and healthy person, the production of nitric oxide (NO) by the endothelium, the inner lining of the blood vessel, is responsible for a) the ability of the blood vessel to dilate so it can increase its blood flow and b) act as an anti-clotting product to prevent blood clotting in those vessels. Under physiological stress either due to the development of a disease such as diabetes or simply from aging, the endothelial cells can be impacted and become dysfunctional thereby impairing their ability to make NO and even promote the development of blood clots. When such endothelial dysfunction occurs, it may be a precursor for the future development of cardiovascular (CV) disease like hypertension or even coronary artery disease later on in life in these patients. Therefore, the ability to somehow enhance the local production or availability of NO within such affected blood vessels in patients identified as prone to endothelial dysfunction could play a positive role in either preventing or delaying the onset of endothelial dysfunction and subsequent CV disease in such patients. COMP-4 is a safe, clinically available, well tolerated oral supplement that has been shown in the lab to increase NO production in a number of differing tissues including human vascular endothelial cells. In this proposed human study, the investigators plan on recruiting healthy, young participants willing to take COMP-4 for a 14 day period in whom the investigators will measure in a non-invasive way - by the use of ultrasound - the effect of COMP-4 on its ability to improve blood flow in one of the major blood vessels of the upper arm. In addition, the investigators will also determine whether COMP-4 will be capable of lowering in the blood the levels of two of the most studied inflammatory markers associated with endothelial dysfunction, IL-8 and PAI-1.
Interventions
- DIETARY_SUPPLEMENT COMP-4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2025-11-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05595915
The ClinicalTrials.gov registry entry for NCT05595915 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which COMP-4 is the first listed.
NCT05595915 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05595915 about?
NCT05595915 is a clinical study titled "COMP-4 Supplementation and Brachial Artery FMD". In a young and healthy person, the production of nitric oxide (NO) by the endothelium, the inner lining of the blood vessel, is responsible for a) the ability of the blood vessel to dilate so it can increase its blood flow and b) act as an anti-clotting product to prevent blood clotting in those ves...
What is the current status of trial NCT05595915?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2023-06-01. Estimated completion is 2025-11-22.
What interventions are being tested in trial NCT05595915?
The interventions under investigation include: COMP-4 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05595915?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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