Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Exercise performance
研究概览
简要总结
This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as cerebral blood flow and cognitive function will be assessed.
详细描述
During training stages in order to prepare for an important event, sleep and recuperation are almost equally important as the appropriate training strategy. This training strategy often consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep quality and thus compromises the overall training efficiency. Ketones are recently found to improve sleep quality, thus potentially playing a pivotal role in altitude training. Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia, after training in normoxia. Moreover, the effect on a performance test, during a simulated 30 min time trial on the next morning, will be investigated. During this protocol, cerebral blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart rate variability, and cognitive function.
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, Investigator)
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
- •Written informed consent must be obtained prior to any experimental procedures
- •Males between 18 and 35 years old
- •Recreational or competitive cyclists performing regular 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
- •Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire
排除标准
- •Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening
- •Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening.
- •Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- •Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500m during the last 3 months preceding the study.
- •Night-shifts or travel across time zones in the month preceding the study
- •Blood donation within 3 months prior to the start of the study
- •More than 3 alcoholic beverages per day
- •Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety
- •Excessive daytime sleepiness as assessed by the Epworth scale
- •Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory. Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated.
- •History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire
- •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
Exercise performance
时间窗: 30 minutes on the second morning of the protocol
Measured as the average power output (W) during a 30 minutes time trial
Change in nocturnal oxygen saturation
时间窗: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Measured using pulse oximetry
Absolute amount of nocturnal urinary catecholamine excretion
时间窗: Subjects empty bladder before sleep and urine will be collected throughout the entire duration of the night, up to 9 hours after individual bedtime and in the morning immediately after waking up
Measured using ELISA of collected nocturnal urine
Duration of different sleep stages
时间窗: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Measured using polysomnography
次要结局
未报告次要终点