CompletedNot Applicable

The Effect of Intermittent Fasting on Acute Subconcussive Head Impacts

United States40 participantsStarted 2022-01-23

Plain-language summary

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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-30 years of age * At least three years of soccer heading experience Exclusion Criteria: * Diabetes * 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 * Pregnant * HIV

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at whether intermittent fasting affects brain recovery after repeated subconcussive head impacts — based on what the researchers found about blood biomarkers and brain imaging changes, does any of that evidence apply to my situation or sport?
2Since this trial is already completed, would it be worth asking the research team or my doctor whether results have been published, and what the findings showed about whether fasting actually made a difference in brain health markers?
3The study tracked changes in things like brain-derived blood biomarkers and brain connectivity over just a few days — does my doctor think those short-term measurements are meaningful enough to influence how I should approach head impact recovery right now?
4Intermittent fasting was the key intervention here — given my current health, diet, and activity level, is intermittent fasting even something my doctor would consider safe or practical for me to try in the context of managing subconcussive impacts?
5Are there standard, already-proven approaches to managing repeated subconcussive head impacts that my doctor would recommend I consider before or alongside anything suggested by a completed early-phase study like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in brain-derived blood biomarkers from day 4 to day 5 and group differences

Timeframe: Blood samples will be collected at day 4 (prior to heading) and day 5 (24 hours post-heading).

Change in brain-derived blood biomarkers from day 4 to day 7 and group differences

Timeframe: Blood samples will be collected at day 4 (prior to heading) and day 7 (72 hours post heading).

Change in regional fMRI activation during the memory task from day 4 to day 5 and group differences

Timeframe: fMRI procedures will be performed on day 4 (prior to heading) and day 5 (24 hours post-heading)

Change in regional fMRI activation during the memory task from day 4 to day 7 and group differences

Timeframe: fMRI procedures will be performed on day 4 (prior to heading) and day 7 (72 hours post-heading)

Change in regional resting state functional connectivity from day 4 to day 5 and group differences

Timeframe: fMRI procedures will be performed day 4 (prior to heading) and day 5 (24 hours post-heading).

Change in regional resting state functional connectivity from day 4 to day 7 and group differences

Trial details

NCT IDNCT05236127

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

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