Priming Effects of Ketone Monoester Supplementation on Theta-Burst Stimulation-Induced Plasticity in the Primary Motor Cortex
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Motor evoked potential (MEP)
研究概览
简要总结
Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent- and continuous-theta burst stimulation (iTBS/cTBS) are increasingly used protocols to enhance or suppress M1 excitability, respectively, beyond stimulation. However, the poor reproducibility and high inter-individual variability in responses to TBS protocols are matters of concern. This study will explore whether ketone monoester supplementation can boost TBS efficacy via their mechanistic convergence on Brain-Derived Neurotrophic Factor (BDNF).
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young adults (18-35 years old)
- •Right-handed
- •Fully vaccinated against COVID-19
排除标准
- •Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS safety
- •Highly active subjects (athletes)
- •Obese (BMI ≥ 30 kg/m2)
- •Following intermittent fasting or ketogenic diet
- •Long COVID-19
研究组 & 干预措施
KME then placebo supplement with iTBS stimulation
KME drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with iTBS stimulation over the left M1 hand region
干预措施: Ketone Monoester (KME) (Dietary Supplement)
KME then placebo supplement with iTBS stimulation
KME drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with iTBS stimulation over the left M1 hand region
干预措施: Placebo (Dietary Supplement)
KME then placebo supplement with iTBS stimulation
KME drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with iTBS stimulation over the left M1 hand region
干预措施: iTBS (Device)
Placebo then KME supplement with iTBS stimulation
Placebo drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with iTBS stimulation over the left M1 hand region
干预措施: Ketone Monoester (KME) (Dietary Supplement)
Placebo then KME supplement with iTBS stimulation
Placebo drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with iTBS stimulation over the left M1 hand region
干预措施: Placebo (Dietary Supplement)
Placebo then KME supplement with iTBS stimulation
Placebo drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with iTBS stimulation over the left M1 hand region
干预措施: iTBS (Device)
KME then placebo supplement with cTBS stimulation
KME drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with cTBS stimulation over the left M1 hand region
干预措施: Ketone Monoester (KME) (Dietary Supplement)
KME then placebo supplement with cTBS stimulation
KME drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with cTBS stimulation over the left M1 hand region
干预措施: Placebo (Dietary Supplement)
KME then placebo supplement with cTBS stimulation
KME drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with cTBS stimulation over the left M1 hand region
干预措施: cTBS (Device)
Placebo then KME supplement with cTBS stimulation
Placebo drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with cTBS stimulation over the left M1 hand region
干预措施: Ketone Monoester (KME) (Dietary Supplement)
Placebo then KME supplement with cTBS stimulation
Placebo drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with cTBS stimulation over the left M1 hand region
干预措施: Placebo (Dietary Supplement)
Placebo then KME supplement with cTBS stimulation
Placebo drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with cTBS stimulation over the left M1 hand region
干预措施: cTBS (Device)
结局指标
主要结局
Motor evoked potential (MEP)
时间窗: Pre-TBS (baseline) and post-TBS at 0, 5, 10, 20, and 30 minutes.
Peak-to-peak MEP amplitude elicited by single-pulse TMS over the left M1 representation of the first dorsal interosseous (FDI) muscle. In each MEP measurement, 12 MEP readings will be collected, elicited by single-pulse TMS at an intensity of 120% resting motor threshold and separated by 15 seconds. In each timepoint post-TBS, the mean value of MEPs (aka, conditioned MEPs) will be averaged and compared to pre-TBS (aka, baseline MEPs) using the following equation: (conditioned MEP amplitude/baseline MEP amplitude) × 100. A value of 90-110 represents no change, while values \< 90% represent suppression and \> 110% facilitation of the M1 plasticity following TBS.
次要结局
- TMSens_Q questionnaire(At 30 minutes post-TBS stimulation)
- Corticospinal excitability indices(Pre-KME supplementation and at 1 hour post-KME supplementation)
- Blood pressure(Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and serially thereafter every 3-5 minutes until 30 minutes post-TBS)
- Heart rate(Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and continuously thereafter for 30 minutes post-TBS)
- Blood glucose(Pre-KME supplementation and at 30 minutes post-TBS stimulation)
- BDNF genetic polymorphism(At the baseline (pre-KME supplementation))
- Blood beta-hydroxybutyrate(Pre-KME supplementation and at 30 minutes post-TBS stimulation)
- Serum brain-derived neurotrophic factor(Pre-KME supplementation and at 30 minutes post-TBS stimulation)
研究者
Wan Aliaa Wan Sulaiman
Associate Professor
Universiti Putra Malaysia