Acute and Sustained Effects of Plant- Based Bio-Equivalent Nitrate Supplement Tablets on Blood Pressure Reduction, Nitric Oxide Mediated Endothelial Function and Saliva Bioconversion of Dietary Nitrate in Hypertensive Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Rate of change in blood pressure
研究概览
简要总结
The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.
详细描述
This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 40-75 years
- •Hypertension >130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
- •Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
排除标准
- •Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- •Weight in excess of 250 pounds
- •Bleeding disorder
- •History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
- •NYHA Class II- IV heart failure
- •History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
- •Serum creatinine > 1.4 mg/dl
- •Triglycerides > 400 at visit 1
- •Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
- •Concurrent enrollment in another placebo-controlled trial
- •Partial ileal bypass or known gastrointestinal disease limiting drug absorption
- •Current tobacco use
- •Current use of anticoagulants (except for anti-platelet agents)
- •Renal failure
- •History of hypertensive encephalopathy or cerebrovascular accident
- •Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
- •Pregnancy
研究组 & 干预措施
plant based bioequivalent dietary nitrate supplement
The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
干预措施: Plant based bioequivalent Nitrate supplementation (Dietary Supplement)
placebo
The Placebo does not contain any nitric oxide supplement.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Rate of change in blood pressure
时间窗: 12 weeks
change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo
次要结局
- changes in serum, plasma and salivary Nitrite and Nitrate(12 weeks)
- cardiometabolic relevant biomarkers (as compared to placebo)(12 weeks)
研究者
Matthew J. Budoff
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center