The Effect of Intermittent Fasting on Acute Subconcussive Head Impacts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in regional resting state functional connectivity from day 4 to day 5 and group differences
研究概览
简要总结
The purpose of this study is to examine the effect of intermittent fasting on the acute neural responses to subconcussive head impacts. The study is designed to identify the effects of 20 controlled soccer headings in college-aged soccer players in one of four groups (fasted, pre-fasted, post-fasted, or control) through the use of neural-injury blood biomarkers, magnetic resonance spectroscopy, functional, and diffusion MRI, and ocular-motor function across 4 acute time points. The central hypothesis is that the neuronal structural, physiological, and functional impairments from the subconussive head impacts will be lessened by intermittent fasting either before or after the soccer headings. The neural-injury blood biomarkers neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Ubiquitin C-Terminal Hydrolase L1 (UCH-L1), and Tau will be measured in serum, with the hypothesis that fasting prior to the 20 soccer headings will result in a decreased heightened response compared to the post-heading fasted group and the controls. It is also hypothesized that repetitive subconcussive head impacts will impair neurocognitive function, as measured by regional changes in fMRI activation during a working memory task in the fasted groups. Twenty headings will significantly alter fMRI activation in the fasted groups from baseline. This impairment will not be observed in the control group. White matter microstructure will be measured by diffusion imaging metrics, with the hypothesis that 20 soccer headings will significantly disrupt microstructure in the fasted groups compared to baseline, but not in the control group. The study will also assess neuro-opthalmologic function as measured by the King-Devick test (KDT) and oculomotor function as measured by near-point-of-convergence (NPC) in response to subconcussive head impacts. The hypothesis is that NPC performance will be significantly impaired for longer than 24 hours in all the groups, but this impairment will be greater in the control group, and that the learning curve and expected improvement of KDT will be significantly blunted in both groups, with a display worsening in the control group.
详细描述
The researchers will use a randomized controlled trial design and recruit participants on a first-come, first-serve basis for the study. The four groups are; 8 day fast, 5 day pre-heading fast, 3 day post-heading fast, and control.
The study consists of 4 data collection time points in an 8-day period. The four data collection sessions will last approximately 2 hours. This study design will enable the researchers to test outcome measures over subacute and acute phases.
- On day 0. the 1st test session takes place immediately prior to the 8-day period.
- On day 4, the 2nd test session takes place right before the soccer heading.
- Participants will perform the soccer headers.
- On day 5, the 3rd test session takes place 24 hours after the soccer heading.
- On day 7, the 4th test session takes place 72 hours after the soccer heading.
When written informed consent is obtained, the researchers will use a self-reported health questionnaire to obtain demographic information. The information includes age, sex, race/ethnicity, years of soccer playing and heading experience, number and age of previous concussions, sleep habits, menstrual cycle, and diet history as well as assessment of other neurological conditions to screen participants' eligibility. Participants who meet the inclusion criteria and are free of exclusionary factors will advance to the testing procedures.
Soccer Heading:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary investigator will be blinded to the study participants' study group status. Additionally, the statistician will be blinded from group assignment.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-30 years of age
- •At least three years of soccer heading experience
排除标准
- •Any current intermittent fasting or in the last 3-6 months
- •Any head or eye injury 12 months prior to the study
- •Any neurological disorders (e.g., seizures, closed head injuries with prolonged loss of consciousness (> 15 minutes), history of stroke, spinal cord/surgery)
- •History of vestibular, ocular, or vision dysfunction
- •Any injury that would prohibit the performance of soccer headings
- •A history of eating disorder
- •Any brain implants or recent surgeries with metal implants that prohibit undergoing an MRI
- •Currently taking any medications affecting appetite
结局指标
主要结局
Change in regional resting state functional connectivity from day 4 to day 5 and group differences
时间窗: fMRI procedures will be performed day 4 (prior to heading) and day 5 (24 hours post-heading).
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to collect resting state functional connectivity.
Change in regional fMRI activation during the memory task from day 4 to day 5 and group differences
时间窗: fMRI procedures will be performed on day 4 (prior to heading) and day 5 (24 hours post-heading)
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to collect fMRI images while a working memory task is administered. The task based fMRI protocol consists of N-back verbal working memory and a resting state task.
Change in regional fMRI activation during the memory task from day 4 to day 7 and group differences
时间窗: fMRI procedures will be performed on day 4 (prior to heading) and day 7 (72 hours post-heading)
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to collect fMRI images while a working memory task is administered. The task based fMRI protocol consists of N-back verbal working memory and a resting state task.
Change in brain-derived blood biomarkers from day 4 to day 5 and group differences
时间窗: Blood samples will be collected at day 4 (prior to heading) and day 5 (24 hours post-heading).
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum samples will be aliquoted and stored at -80 degree celsius until analysis. Serum samples will be assayed for neurofilament-light (NfL) and glial fibrillary acidic protein (GFAP). All expression levels in pg/mL.
Change in brain-derived blood biomarkers from day 4 to day 7 and group differences
时间窗: Blood samples will be collected at day 4 (prior to heading) and day 7 (72 hours post heading).
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum samples will be aliquoted and stored at -80 degree celsius until analysis. Serum samples will be assayed for neurofilament-light (NfL) and glial fibrillary acidic protein (GFAP). All expression levels in pg/mL.
Change in axonal microstructure from day 4 to day 7 and group differences
时间窗: MRI procedures will be performed day 4 (prior to heading) and day 7 (72 hours post-heading).
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in diffusion metrics. Whole-brain Diffusion tensor imaging (DTI) will be performed with a multi-slice single-shot spin echo echoplanar pulse sequence (echo time \[TE\] = 81 ms; repetition time \[TR\] = 9 s) using 64 diffusion-encoding directions, isotopically distributed over the surface of a sphere with electrostatic repulsion.
Change in regional resting state functional connectivity from day 4 to day 7 and group differences
时间窗: fMRI procedures will be performed day 4 (prior to heading) and day 7 (72 hours post-heading).
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to collect resting state functional connectivity.
Change in axonal microstructure from day 4 to day 5 and group differences
时间窗: MRI procedures will be performed day 4 (prior to heading) and day 5 (24 hours post-heading).
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in diffusion metrics. Whole-brain Diffusion tensor imaging (DTI) will be performed with a multi-slice single-shot spin echo echoplanar pulse sequence (echo time \[TE\] = 81 ms; repetition time \[TR\] = 9 s) using 64 diffusion-encoding directions, isotopically distributed over the surface of a sphere with electrostatic repulsion.
Change in a panel of metabolites from day 4 to day 5 and group differences
时间窗: MRI procedures will be performed day 4 (prior to heading) and day 5 (24 hours post-heading).
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in neurometabolic metrics. The metabolic panel includes the following: N-Acetylaspartate (NAA), Glutamine/Glutamate (Glx), Myo-Inositol (mI), Choline (Cho), and Creatine (Cr).
Change in a panel of metabolites from day 4 to day 7 and group differences
时间窗: MRI procedures will be performed day 4 (prior to heading) and day 7 (72 hours post-heading).
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in neurometabolic metrics. The metabolic panel includes the following: N-Acetylaspartate (NAA), Glutamine/Glutamate (Glx), Myo-Inositol (mI), Choline (Cho), and Creatine (Cr).
次要结局
- Change in near point of convergence from day 4 to day 7 and group differences(Near point of convergence will be assessed at day 4 (prior to heading) and day 7 (72 hours post-heading).)
- Change in King Devick performance from day 4 to day 7 and group differences(King Devick performance will be assessed at day 4 (prior to heading) and day 7 (72 hours post-heading).)
- Change in near point of convergence from day 0 to day 4 and group differences(Near point of convergence will be assessed at day 0 and day 4 (prior to heading).)
- Change in brain-derived blood biomarkers from day 0 to day 4 and group differences(Blood samples will be collected at day 0 and day 4 (prior to heading).)
- Change in King Devick performance from day 0 to day 4 and group differences(King Devick performance will be assessed at day 0 and day 4 (prior to heading))
- Change in brain-derived blood biomarkers from day day 0 to day 5 and group differences(Blood samples will be collected at day 0 and day 5 (24 hours post heading).)
- Change in brain-derived blood biomarkers from day day 0 to day 7 and group differences(Blood samples will be collected at day 0 and day 7 (72 hours post heading).)
研究者
Keisuke Kawata
Assistant Professor Kinesiology
Indiana University