Effect of Oral Ketone Administration on Cognitive Function, Musculoskeletal Damage and Hormonal and Metabolic Dysregulations Induced by Ultra-endurance Running
试验速览
- 阶段
- 2 期
- 发起方
- KU Leuven
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Countermovent jump
研究概览
简要总结
The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18 and 55 years old
- •Recreational or competitive runner having performed an ultramarathon (>42km) during the last 2 years
- •Good health status confirmed by a medical screening
- •Body Mass Index (BMI) between 18 and 25
排除标准
- •Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
- •Intake of any medication or nutritional supplement that is known to affect exercise performance
- •Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- •Blood donation within 3 months prior to the start of the study
- •More than 3 alcoholic beverages per day
- •Current participation in another research trial
- •Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
- •Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)
研究组 & 干预措施
Ketone ester
Subjects receive the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race.
干预措施: Ketone ester (Dietary Supplement)
Con
Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Countermovent jump
时间窗: Before race - immediately after race - 48 hours after start of race
Change in countermovement jump height
Skeletal muscle inflammatory cell infiltration
时间窗: Before race - 48 hours after start of race
Change in infiltration of inflammatory cells in skeletal muscle
Reaction time
时间窗: Before race - immediately after race
Change in reaction time during a reaction time task
Exercise performance
时间窗: Immediately after race
Time needed to complete the ultrarun
次要结局
- Catecholamines in blood(Before race - immediately after race - 48 hours after start of race)