Effect of Ketone Ester Supplementation on Hypoxic Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in oxygenation status of brain, blood, muscle
研究概览
简要总结
This WP specifically aims to elucidate the effects of IEK on hypoxic tolerance and the development and severity of AMS symptoms, blood and tissue oxygenation status, as well as sleep quality during an episode of acute exposure to severe hypoxia.
详细描述
Acute altitude exposure impairs exercise tolerance and performance, decreases the rate of maximal oxygen uptake (V̇O2max), cognitive function and sleep quality, and often also induces symptoms of acute mountain sickness (AMS). Previous studies have clearly indicated that ketone bodies exert a neuroprotective effect under hypoxic-ischemic conditions as well as improve hypoxic tolerance in rodents. In support of these earlier observations, recent pilot experiments in young volunteers in our laboratory provide proof of concept that IEK can attenuate oxygen desaturation during exercise in hypoxia. Therefore, given that impaired exercise tolerance in hypoxia is primarily due to impaired oxidative energy production in active tissues (brain and muscle), we hypothesize that IEK can increase blood and tissue (muscle and brain) oxygenation status in hypoxia and thereby enhance global hypoxic tolerance, as well as improve exercise tolerance and endurance exercise performance.
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
- •Males or females between 18 and 35 years old
- •Body Mass Index (BMI) between 18 and 25
- •Physically fit and regularly involved in physical activity (2-5 exercise sessions of > 30min per week)
- •Good health status confirmed by a medical screening
- •Non smoking
- •Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI, appendix 2)
排除标准
- •Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise
- •Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep
- •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 a period of 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
- •Involvement in elite athletic training at a semi-professional or professional level
- •Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
研究组 & 干预措施
Ketone group
Ketone esters will be provided
干预措施: Ketone ester (Dietary Supplement)
Placebo group
Ketone placebo will be provided
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in oxygenation status of brain, blood, muscle
时间窗: Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Measured by NIRS, pulse oximetry, blood samples
Change in cerebral blood flow
时间窗: Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Measured using duplex ultrasound
Change in incidence of acute mountain sickness symptoms
时间窗: Hour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Scored by Lake Louise Scoring system
Time in hypoxia
时间窗: From start of hypoxic exposure until subjects are too sick to comply to (supplementation) protocol or until end of protocol, up to 29 hours
Total time that subjects were able to comply to the experimental protocol and supplementation protocol
次要结局
- Sleep quality(Throughout the entire duration of the night, up to 9 hours after individual bedtime)