Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in sleep quality
研究概览
简要总结
The purpose of this study is to investigate the effects of acute inorganic nitrate supplementation (with beetroot) on the regulation of sleep and neurovascular physiology.
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
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •18-35 or 65-80 years of age
排除标准
- •Coronary artery disease
- •Heart failure
- •Pregnancy
- •Sleep disorders
- •Shift workers
- •Individuals who typically go to sleep after midnight
- •Individuals who traveled across ≥2 time zones within one week of study visits
- •Individuals with a history frequent kidney stones
- •BMI ≥35.0kg/m2
- •Use of nicotine-containing products within the two years preceding study visits
- •Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with the nitrate-nitrite-nitric oxide pathway or outcome measures
研究组 & 干预措施
Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)
Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3.
干预措施: Placebo Beetroot Juice Supplement (pBRJ) (Dietary Supplement)
Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)
Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3.
干预措施: Active Beetroot Juice Supplement (aBRJ) (Dietary Supplement)
Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)
Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3.
干预措施: Placebo Beetroot Juice Supplement (pBRJ) (Dietary Supplement)
Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)
Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3.
干预措施: Active Beetroot Juice Supplement (aBRJ) (Dietary Supplement)
结局指标
主要结局
Change in sleep quality
时间窗: Baseline, approximately 30 days, and approximately 60 days
Measured by Pittsburgh Sleep Quality Index which measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Change in daytime sleepiness
时间窗: Baseline, approximately 30 days, and approximately 60 days
Measured by Epworth Sleepiness Scale. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is graded from 0-24. 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention.
Change in the amount of time in stage three sleep
时间窗: Baseline, approximately 30 days, and approximately 60 days
Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes
Change in self-reported sleep quality
时间窗: Baseline, approximately 30 days, and approximately 60 days
Measured on a visual analog scale of 1-10, where 1 is not at all sleepy and 10 is as sleepy as you can imagine, how sleepy are you right now?
Change in sleepiness
时间窗: Baseline, approximately 30 days, and approximately 60 days
Measured by the Stanford Sleepiness Scale that asks participate to rank their degree of sleepiness where 1 would indicate the subject currently feels least sleepy and 7 would indicate the subject feels the most sleepy.
次要结局
- Change in sympathetic nerve burst incidence(Baseline, approximately 30 days, and approximately 60 days)
- Change in arterial stiffness(Baseline, approximately 30 days, and approximately 60 days)
- Change in total muscle sympathetic nerve activity (MSNA)(Baseline, approximately 30 days, and approximately 60 days)
- Change in blood pressure(Baseline, approximately 30 days, and approximately 60 days)
- Change in endothelial function(Baseline, approximately 30 days, and approximately 60 days)
- Change in sympathetic nerve burst frequency(Baseline, approximately 30 days, and approximately 60 days)
- Change in sympathetic nerve burst amplitude (AU)(Baseline, approximately 30 days, and approximately 60 days)
研究者
Joshua M. Bock
Principal Investigator
Mayo Clinic