NCT Number: NCT07469475
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
UCLA, Los Angeles, California, United States
This study examines the effect of six weeks of daily supplementation on a panel of blood markers associated with vascular aging and inflammation.
The blood markers Plasminogen Activator Inhibitor-1 (PAI-1), Interleukin-8 (IL-8), Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), Fibroblast Growth Factor 23 (FGF-23), C-Reactive Protein (CRP), and Klotho will be measured. PAI-1 is a protein involved in blood clotting whose elevated levels are associated with increased cardiovascular risk and aging. IL-8 is a pro-inflammatory cytokine linked to chronic inflammation. PCSK9 is involved in lipid metabolism and cardiovascular risk. FGF-23 is a regulator of phosphate metabolism and vascular calcification. CRP is a general marker of system inflammation, and Klotho is an anti-aging protein with protective effects on vascular and renal function.
By assessing these markers, this study seeks to determine whether a natural oral supplement can modulate key pathways involved in vascular inflammation and aging, potentially positioning it as a natural oral supplement that may support vascular health in the context of age-related decline.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will consume a supplement called RM, which is composed of ginger extract, L-citrulline, and the herbal components Paullinia cupana and muira puama.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
Blood levels of Plasminogen Activator Inhibitor-1 (PAI-1), a marker that correlates with aging and risk of cardiovascular disease, will be measured through a standard blood draw. Measurement units are ng/mL.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
The blood marker Interleukin-8 (IL-8) will be measured through a standard blood draw. IL-8 is a pro-inflammatory cytokine linked to chronic inflammation. Measurement units are pg/mL.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
The blood marker Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) will be measured through a standard blood draw. PCSK9 is involved in lipid metabolism and cardiovascular risk. Measurement units are ng/mL.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
The blood marker Fibroblast Growth Factor 23 (FGF-23) will be measured through a standard blood draw. FGF-23 is a regulator of phosphate metabolism and vascular calcification. Measurement units are pg/mL.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
The blood marker C-Reactive Protein (CRP) will be measured through a standard blood draw. CRP is a general marker of systemic inflammation. Measurement units are mg/dL.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
The blood marker Klotho will be measured through a standard blood draw. Klotho is an anti-aging protein with protective effects on vascular and renal function. Measurement units are pg/mL.
Time frame: From enrollment to the end of treatment at 6 weeks +/- 7 days
Systolic and diastolic blood pressure will be measured. Measurement units are mm Hg.
University of California, Los Angeles
Other
Effect of a Daily Nitric Oxide-Stimulating Supplement on Plasma PAI-1 Levels: a Six-Week, Open-Label Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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