Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Exercise Tolerance
研究概览
简要总结
The purpose of this project will be to determine whether consumption of beet juice concentrate prior to exercise may acutely improve exercise tolerance in patients with heart failure.
详细描述
Participants will complete up to four study visits. The first visit will involve completion of the informed consent process followed by a screening for study eligibility. The screening will consist of questionnaires pertaining to detailed medical history, diet, physical activity, and health-related quality of life (KCCQ). Anthropometric measures and a general health screening (including heart rate, resting blood pressure, and small blood (<15 mL) and urine samples will be collected). Volunteers meeting eligibility requirements will be scheduled for a screening maximal cardiopulmonary exercise test. Immediately prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing. Qualified subjects will then undergo a maximal cardiopulmonary exercise (CPX) test.
Following successful completion of the screening CPX test, volunteers meeting eligibility requirements will be scheduled for two testing visits, at least one week apart. At one visit, participants will consume a small cup of beet juice concentrate, and at the other, they will consume placebo. Treatment will be double-blinded and administered in random order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association (NYHA) class II-III heart failure
- •receiving optimal medical therapy
- •sedentary
排除标准
- •changes in medication or major cardiovascular (CV) event or procedure within the previous 6 wk
- •fixed rate pacemaker
- •unstable angina
- •other co-morbidities or limitations that preclude safe participation in the exercise testing
- •plans for hospitalization or cardiac transplantation within the next 2 months
- •type 1 diabetes
- •refusal or inability to provide informed consent
研究组 & 干预措施
placebo
placebo drink, single dose, taste and color-matched to experimental drink
干预措施: placebo (Other)
beet juice concentrate
single dose of beet juice concentrate, roughly 70 mL
干预措施: beet juice concentrate (Drug)
结局指标
主要结局
Exercise Tolerance
时间窗: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
treadmill time to exhaustion, cardiopulmonary exercise test
次要结局
- Vascular Function(Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline))
研究者
Jason Allen, Ph.D.
Assistant Professor of Medicine
Duke University
