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临床试验/NCT01946542
NCT01946542终止1 期

Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

Jason Allen, Ph.D.1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

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

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 Comparator

placebo drink, single dose, taste and color-matched to experimental drink

干预措施: placebo (Other)

beet juice concentrate

Experimental

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

发起方
Jason Allen, Ph.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jason Allen, Ph.D.

Assistant Professor of Medicine

Duke University

研究点 (1)

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