Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in inspiratory muscle function
研究概览
简要总结
Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The overarching goal of this double-blind, randomized, crossover, placebo-controlled pilot trial was to inform the development of a fully powered trial to evaluate the effects of dietary nitrate supplementation in older adults with CAD. We aimed to address the following objectives: (a) assess the feasibility, tolerability, and safety of the study protocol; (b) gather preliminary evidence on the effects of nitrate-rich beetroot juice compared with nitrate-depleted beetroot juice (placebo), and estimate the effect sizes; and (c) determine if a full-scale definitive trial is justified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with coronary artery disease (CAD) based on an angiogram >50% stenosis in any major epicardial vessel or history of myocardial infarction or history of coronary revascularization.
- •Considered to have stable CAD on optimal medical therapy
- •60 to 85 years of age
- •Males and females (females must be postmenopausal either natural or surgical)
- •Able to give consent
排除标准
- •Unstable angina, recent myocardial infarction or heart failure within 6 months
- •Coronary revascularization, including percutaneous coronary intervention and coronary artery bypass graft or thoracic surgery within 6 months.
- •Stroke, obstructive pulmonary disease, hepatitis B, C, HIV, seizures, or other relevant ongoing or recurrent illness
- •Individuals who have participated in respiratory training within the last 12 months or cardiac rehabilitation within the last 6 months
- •Uncontrolled hypertension
- •Use of tobacco products including smoking traditional or e-cigarettes
- •Use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
- •Unwilling to stop using mouthwash at least 1 week before the start of the study and during study participation
- •Unwilling to remain weight stable during study participation
研究组 & 干预措施
Nitrate rich beetroot juice
干预措施: Nitrate rich beetroot juice (Dietary Supplement)
Nitrate depleted beetroot juice
干预措施: Nitrate depleted beetroot juice (Dietary Supplement)
结局指标
主要结局
Change in inspiratory muscle function
时间窗: Baseline up to following 2 weeks of experimental condition
Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device
Change in endothelial function
时间窗: Baseline up to following 2 weeks of experimental condition
Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to \~250 mmHg for 5 minutes followed by rapid deflation.
次要结局
- Change in microvascular function(Baseline up to following 2 weeks of experimental condition)
- Change in central arterial stiffness(Baseline up to following 2 weeks of experimental condition)
- Change in central arterial hemodynamics(Baseline up to following 2 weeks of experimental condition)
- Change in functional capacity(Baseline up to following 2 weeks of experimental condition)