Effect of a Daily Nitric Oxide-Stimulating Supplement on Plasma PAI-1 Levels: a Six-Week, Open-Label Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in Blood Level of Plasminogen Activator Inhibitor-1 Between Baseline and 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People of any gender at least 18 years of age who do not have a history of acute or chronic cardiovascular illnesses are eligible.
排除标准
- •Younger than 18 years of age
- •Currently pregnant (which will be confirmed by pregnancy test for participants capable of pregnancy)
- •Using hormonal birth control
- •Current smoker
- •Allergy to ginger, muira puama, Paullinia cupana, or L-citrulline
- •Previous use of Revactin® or RM
- •History of serious cardiovascular events, including myocardial infarction (heart attack) or stroke
- •History of coronary, cardiac, or carotid surgery such as a stent, heart surgery, or endarterectomy
- •Active cancer of any type other than skin cancer
研究组 & 干预措施
Supplement
All subjects recruited in this study will be in the experimental group receiving the oral supplement to consume twice daily for 42 days.
干预措施: Supplement with ginger extract, L-citrulline, Paullinia cupana, and muira puama (Dietary Supplement)
结局指标
主要结局
Change in Blood Level of Plasminogen Activator Inhibitor-1 Between Baseline and 6 Months
时间窗: 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.
次要结局
- Change in Blood Level of Interleukin-8 Between Baseline and 6 Months(From enrollment to the end of treatment at 6 weeks +/- 7 days)
- Change in Blood Level of Proprotein Convertase Subtilisin/Kexin Type 9 Between Baseline and 6 Months(From enrollment to the end of treatment at 6 weeks +/- 7 days)
- Change in Blood Level of Fibroblast Growth Factor 23 (FGF-23) Between Baseline and 6 Months(From enrollment to the end of treatment at 6 weeks +/- 7 days)
- Change in Blood Level of C-Reactive Protein Between Baseline and 6 Months(From enrollment to the end of treatment at 6 weeks +/- 7 days)
- Change in Blood Level of Klotho Between Baseline and 6 Months(From enrollment to the end of treatment at 6 weeks +/- 7 days)
- Change in Blood Pressure Between Baseline and 6 Months(From enrollment to the end of treatment at 6 weeks +/- 7 days)
研究者
Sriram Eleswarapu
Associate Professor of Urology
University of California, Los Angeles