The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in metabolic efficiency during exercise
研究概览
简要总结
Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication metabolic inefficiency
排除标准
- •Sodium intake limitation
- •Long-term oxygen therapy
- •Severe renal impairment
- •Use of medications that may interact with nitrate
- •Contra-indications for performing (sub)maximal cycle ergometry
研究组 & 干预措施
Nitrate supplementation
Sodium nitrate solution
干预措施: Nitrate supplementation (Dietary Supplement)
Nitrate supplementation
Sodium nitrate solution
干预措施: Placebo supplementation (Dietary Supplement)
Placebo supplementation
Sodium chloride solution
干预措施: Nitrate supplementation (Dietary Supplement)
Placebo supplementation
Sodium chloride solution
干预措施: Placebo supplementation (Dietary Supplement)
结局指标
主要结局
Change in metabolic efficiency during exercise
时间窗: Baseline, day 7, day 14 and day 21.
Metabolic efficiency (degree of efficiently used energy during exercise) will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.
次要结局
- Change in oxygen uptake (VO2 mL/min) during exercise(Baseline, day 7, day 14 and day 21)
- Change in blood pressure during exercise(Baseline, day 7, day 14 and day 21.)
- Change in dyspnea during exercise(Baseline, day 7, day 14 and day 21.)
- Change in cycle endurance time during exercise.(Baseline, day 7, day 14 and day 21.)
- Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin(Baseline, day 7, day 14 and day 21)
- Change in Resting Energy Expenditure (REE)(Baseline, day 7, day 14 and day 21)