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Effect of a Daily Nitric Oxide-Stimulating Supplement on Plasma PAI-1 Levels: a Six-Week, Open-Label Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

In a 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 promoting 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 coronary artery disease later on in life in these patients. Therefore, the ability to 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. RM is an oral supplement consisting of natural ingredients and the amino acid, L-citrulline. In laboratory experiments with cells from the inner lining of blood vessels, the four components of RM have been shown to increase the concentration of NO and decrease the levels of some aging markers. In our recently completed study (manuscript currently in review), 31 young men and women took the supplement for 14 days and had no serious side effects. The supplement caused the expected potentially beneficial dilation of the blood vessels and decrease in the levels of Plasminogen Activator Inhibitor-1 (PAI-1), whose levels correlate with aging and risk of cardiovascular disease. In this study, healthy participants will consume the supplement for a 6-week period to determine if PAI-1 levels continue to be suppressed and also examine whether the supplement has an effect on other blood markers whose levels can change with aging or cardiovascular disease and may also be indicative or predictive of an illness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• People of any gender at least 18 years of age who do not have a history of acute or chronic cardiovascular illnesses are eligible.

Locations
United States
California
UCLA
RECRUITING
Los Angeles
UCLA The Men's Clinic
RECRUITING
Santa Monica
Contact Information
Primary
Sriram V Eleswarapu, MD, PhD
seleswarapu@mednet.ucla.edu
3107943058
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2026-12
Participants
Target number of participants: 35
Treatments
Experimental: Supplement
All subjects recruited in this study will be in the experimental group receiving the oral supplement to consume twice daily for 42 days.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov

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