Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 3-OHB CSF/blood ratio
研究概览
简要总结
It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.
Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.
To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.
Aims:
- The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint
- The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling
- If concentration measurements by point-of-care testing are non-inferior to mass spectrometry
- If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All sexes
- •Referred to undergo an elective lumbar puncture procedure in the outpatient clinic at Department of Neurology, Aarhus University Hospital.
- •Age 18-80 years
- •Written and oral consent
排除标准
- •Referred to the clinic suspecting severe neuroinflammation
- •Special diet habits, including ketogenic diet, fasting, intermittent fasting etc.
- •Daily use of insulin or other medication affecting blood glucose and/or glucose metabolism
- •Not able to speak or understand Danish and/or give written and oral consent
研究组 & 干预措施
Ketone 1 hour
Ketone ester drink administered one hour before elective lumbar puncture
干预措施: Ketone Ester (Dietary Supplement)
Ketone 2 hours
Ketone ester drink administered two hours before elective lumbar puncture
干预措施: Ketone Ester (Dietary Supplement)
Placebo 1 hour
Placebo drink administered one hour before elective lumbar puncture
干预措施: Placebo (Other)
结局指标
主要结局
3-OHB CSF/blood ratio
时间窗: 1-2 hours after ingestion
After oral ingestion of 30 g ketone ester drink or placebo drink
次要结局
- Plasma BDNF concentrations(Before ingestion)
- CSF 3-OHB concentrations, POCT(1-2 hours after ingestion)
- Blood 3-OHB concentrations(Before ingestion)
- Plasma 3-OHB concentrations(Before ingestion)
- CSF glucose concentrations(1-2 hours after ingestion)
- CSF 3-OHB concentrations, Mass Spectrometry(1-2 hours after ingestion)
- Blood glucose concentrations(Before ingestion)
- Plasma BDNF concentrations(1-2 hours after ingestion)
- Blood 3-OHB concentrations(1-2 hours after ingestion)
- Plasma 3-OHB concentrations(1-2 hours after ingestion)
- Blood glucose concentrations(1-2 hours after ingestion)