Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise
试验速览
- 阶段
- 2 期
- 发起方
- KU Leuven
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Urinary nocturnal adrenaline excretion
研究概览
简要总结
The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added.
Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.
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 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18 and 35 years old
- •Recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week
- •Good health status confirmed by a medical screening
- •Body Mass Index (BMI) between 18 and 25
- •Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI)
- •Moderate sleep chronotype, assessed by the Horne and Östberg questionnaire
排除标准
- •Excessive daytime sleepiness as assessed by the Epworth scale
- •Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory
- •Night-shifts or travel across time zones in the month preceding the study
- •Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
- •Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep
- •Involvement in elite athletic training at a semi-professional or professional level
- •Current participation in another research trial
- •Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
结局指标
主要结局
Urinary nocturnal adrenaline excretion
时间窗: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Change in urinary nocturnal adrenaline excretion between conditions
Urinary nocturnal noradrenaline excretion
时间窗: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Change in urinary nocturnal adrenaline excretion between conditions
Total sleep time
时间窗: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Change in total sleep time between conditions as evaluated with polysomnography
次要结局
- Total non-rapid-eye-movement sleep(Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks))
- Total slow-wave sleep(Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks))
- Plasma adrenaline concentration(Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks))
- Total rapid-eye-movement sleep(Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks))
- Plasma noradrenaline concentration(Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks))