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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: Completed Phase 1 study, sponsored by University of California, Los Angeles.
NCT05595915 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Flow Mediated Dilation (FMD) is a non-invasive procedure in which the response of the blood vessel to ischemia is measured. This procedure is mediated primarily by nitric oxide (NO). COMP-4 is a supplement that has been shown to increase NO availability. The investigators want to study whether COMP-4 will FMD compared to baseline.
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 |
What the finished NCT05595915 record still lists
NCT05595915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which COMP-4 is the first listed.
NCT05595915 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05595915's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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