Effect of a Daily Supplement on Plasma PAI-1 Levels

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT07469475
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Aging
  • Endothelial Dysfunction
  • Senescence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Supplement with ginger extract, L-citrulline, Paullinia cupana, and muira puama — DIETARY_SUPPLEMENT
    Participants will consume a supplement called RM, which is composed of ginger extract, L-citrulline, and the herbal components Paullinia cupana and muira puama.

Study Details

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.

Key Dates

Start date
Feb 24, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Change in Blood Level of Plasminogen Activator Inhibitor-1 Between Baseline and 6 Months [ Time Frame: From enrollment to the end of treatment at 6 weeks +/- 7 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90034
Sriram V Eleswarapu, MD, PhD
[email protected]
310-794-3058
UCLA The Men's ClinicSanta MonicaCalifornia90403
Sriram V Eleswarapu, MD, PhD
[email protected]
310-794-3058

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By research site
UCLA· Los Angeles, CAUCLA The Men's Clinic· Santa Monica, CA

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