Nutritional Intervention to Enhance Sleep Quality and Quantity in Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Total Sleep Time (TST)
研究概览
简要总结
The primary objective is to assess the impact of two nutritional interventions vs. placebo on objective and subjective sleep measures in athletes. Participants receive one beverage on each of three consecutive nights in a randomized manner. It is hypothesized the two nutritional interventions will result in significant improvements in sleep onset latency, and will not result in a negative impact on next-day cycling performance.
The secondary objective is to assess the impact of the nutritional interventions vs. placebo on next-morning performance (physical, cognitive function, and balance).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-40 years old
- •Healthy (assessed via the Exercise and Sports Science Australia (ESSA) survey
- •Endurance trained (2 hours of training at least 3 days per week for a minimum of 3 years)
- •Free from any known sleep disorders or disturbances as assessed by a Pittsburg Sleep Quality Index (PSQI score under 5)
- •Must be willing to live/sleep at the Appleton Institute Sleep Laboratory for 4 (consecutive) nights/5 days (total 96 hours)
- •Must be able to provide written informed consent upon having the study procedure explained to them verbally and in writing.
- •Willing to be prohibited from consuming caffeine and alcohol during the entire stay at the sleep clinic and agree to eat only the standardized meals and snacks and drinks provided.
排除标准
- •Subject has a clinically diagnosed sleeping disorder
- •Subject has a change in medication over the duration of the study that is known to affect sleep
- •Subject has a current illness that would affect sleep
- •Subject has a current injury that would prevent him from giving maximal effort during the next-morning performance task
- •Participation in another clinical trial within the past 30 days or another PepsiCo/GSSI study within the past 6 months
结局指标
主要结局
Total Sleep Time (TST)
时间窗: Time from sleep onset to 8:00 a.m.
Measured in minutes during polysomnography. Longer is better.
Arousals
时间窗: From sleep onset to 8 a.m.
Measured as a count during polysomnography. Less arousals are better.
Sleep stage 1, 2, 3 AND REM
时间窗: Measured continuously throughout the night from sleep onset to 8 a.m.
Measured in minutes during polysomnography. Normal stage pattern is better.
Rapid Eye Movement (REM) Latency
时间窗: From sleep onset to REM sleep
Measured in minutes during polysomnography. Shorter time to REM is better.
Stage shifts
时间窗: From sleep onset to 8 a.m.
Measured as a count during polysomnography. Normal amount of stage shifts are better.
Wake After Sleep Onset (WASO)
时间窗: From sleep onset till 8:00 a.m.
Occurrences measured in minutes during polysomnography. None or less are better.
Sleep Efficiency (SE)
时间窗: From sleep onset to 8:00 a.m.
Measured as a % of time asleep over time in bed during polysomnography. Higher efficiency is better
Sleep Onset Latency (SOL)
时间窗: Transition from wakefulness to sleep
Measured in minutes during polysomnography. Shorter time to onset is better.
Sleep stage 3 Latency
时间窗: From sleep onset to deep sleep
Measured in minutes during polysomnography. Shorter time to stage 3 deep sleep is better.
Awakenings
时间窗: From sleep onset to 8 a.m.
Measured as a count during polysomnography. Less awakenings are better.
Subjective Karolinska Sleepiness Scale (KSS)
时间窗: Every thirty minutes from 20:00 p.m. until 22:30 p.m.
Subjective arousal level at present state rated 1 (extremely alert) to 9 (Very sleepy, great effort to keep awake). Sleepiness before bed is better.
(Subjective) Perceived Sleep Quality
时间窗: 08:30 a.m. following polysomnography
Rated from 1 (very good) to 5 (poor). Lower number is better.
(Subjective) Sleep Quantity
时间窗: 08:30 a.m. following polysomnography
Measured in hours and minutes. Higher number is better.
(Subjective) Sleep Onset Latency
时间窗: 08:30 a.m. following polysomnography
Measured in hours and minutes. Lower number is better.
次要结局
- Exercise performance: power output(During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.)
- Exercise performance: perceived exertion(During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.)
- Cognitive performance: sustained attention(10 minute testing period at 9 a.m. Higher performance is better.)
- Subjective alertness(9 a.m. before cognitive performance attention testing.)
- Subjective self-perceived capacity to be fast on cognitive test(9 a.m. before cognitive performance attention testing)
- Balance(9 a.m. before cognitive performance attention testing.)
- Exercise performance: heart rate(During a 10 minute time trial cycling exercise performance testing at 9:30 a.m.)
- Subjective self-perceived capacity to be accurate on cognitive test(9 a.m. before cognitive performance attention testing)