The Role of Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors: a Randomized, Controlled Trial in Individuals With Elevated Blood Pressure
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The project aims to determine the effect of a high-nitrate dietary intervention on blood pressure and markers of vascular function compared to a low-nitrate intervention in people with elevated blood pressure. Half of the participants will receive the high-nitrate dehydrated vegetable intervention, while the other half will receive the low-nitrate dehydrated vegetable intervention.This project will advance the current hypothesis on the therapeutic link between dietary nitrate and high blood pressure, and potentially derive impactful recommendations for individuals at risk of hypertension.
详细描述
Diets rich in fruits and in particular, vegetables, reduce blood pressure (BP) and the risk of cardiovascular events. Increasingly, attention is being given to high-nitrate containing vegetables, with emerging evidence that it might represent a source of vasoactive nitric oxide. Clinical data to date uniformly suggest an acute vasoprotective role of dietary nitrate administration and a BP-lowering effect. Whether the vascular effects extend to long-term intake and in individuals with elevated blood pressure is not well known. The investigators hypothesize that consumption of a dietary intervention high in nitrate from vegetable sources will have a greater effect on BP and related vascular parameters than a similar intervention that is low in dietary nitrates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and study coordinators will be blinded to the nature of the treatment allocation. Stratified randomization lists by baseline sex and age will be created.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 18.5-35 kg/m2
- •Seated systolic blood pressure ≥130 and <160 mmHg
排除标准
- •current use of antihypertensive agents
- •history of major cardiovascular events in the last 1 year (stroke or myocardial infarction)
- •stage II hypertension as per JNC7 criteria (systolic BP/ diastolic BP ≥160/100 mmHg) - angina pectoris
- •gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
- •cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
- •serum triglyceride >4.5mmol/L
- •major disability or disorder requiring continuous medical attention
- •planned initiation in antihypertensive therapy
- •herb or supplement use that may affect primary outcome
- •consuming >3 servings of vegetables/day (based on semi-quantitative food frequency questionnaire)
- •alcohol use >2 drinks/day
- •chronic or prescribed use of medications including prescription NSAIDs, antacids, warfarin, medications affecting NO synthesis (ie. sildenafil, organic nitrates, etc)
- •use of antibiotics within 3-months of the study start
- •participants should also be willing to refrain from using mouthwash (ie chlorhexidine) for the duration of their participation in the study
研究组 & 干预措施
High Nitrate Dehydrated Vegetables
Participants are given high-nitrate dehydrated vegetable powders contained in opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.
干预措施: High-nitrate dehydrated vegetable powder (Other)
Low-Nitrate Dehydrated Vegetables
Participants are given low-nitrate dehydrated vegetable powders contained in three opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.
干预措施: Low-nitrate dehydrated vegetable powder (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: Baseline, 8 and16 weeks
Change in systolic blood pressure vs. control at 16 weeks
次要结局
- Augmentation Index (AI)(Baseline, 8 and 16 weeks)
- Plasma Lipids(Baseline and 16 weeks)
- Aortic Systolic and Diastolic Blood Pressure(Baseline, 8 and 16 weeks)
- High Sensitivity C-reactive protein (hs-CRP)(Baseline and 16 weeks)
- Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure(Baseline and 16 weeks)
- Pulse Wave Velocity (PWV)(Baseline and 16 weeks)
研究者
Vladimir Vuksan
Professor
Unity Health Toronto