Single Dose of Nitrate-rich Beetroot Juice Does Not Improve Steady State Oxygen Consumption or Six-minute Walk Distance in Patients With Systolic Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- six minute walk distance
研究概览
简要总结
Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted.
This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.
There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.
In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.
Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local institutional beneficiaries between the ages of 18 and 80
- •Documentation of left ventricular systolic dysfunction with ejection fraction < 40% by any modality within the past six months
- •Documentation of New York Heart Association class II or III status.
排除标准
- •> 80 years of age
- •Unable to adequately or safely perform treadmill exercise
- •Pulmonary disease deemed significant enough to be a limitation to exercise
- •Greater than moderate stenotic or regurgitant valvular heart disease
- •Presence of atrial fibrillation or other uncontrolled arrhythmias
- •Uncompensated heart failure
- •Continuously paced rhythms
- •Pregnant females
- •Chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical nitroglycerine)
- •Phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week
研究组 & 干预措施
submaximal steady state exercise
90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes
干预措施: nitrate-rich beetroot juice (Dietary Supplement)
submaximal steady state exercise
90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes
干预措施: nitrate-deplete beetroot juice (Dietary Supplement)
six minute walk test
subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed
干预措施: nitrate-rich beetroot juice (Dietary Supplement)
six minute walk test
subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed
干预措施: nitrate-deplete beetroot juice (Dietary Supplement)
结局指标
主要结局
six minute walk distance
时间窗: six minutes
subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.
steady state exercise oxygen consumption
时间窗: 10 minutes
Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.
次要结局
未报告次要终点
研究者
Kenneth M Leclerc
MD
Brooke Army Medical Center