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NCT05236127 · ClinicalTrials.gov registry record · NA
The Effect of Intermittent Fasting on Acute Subconcussive Head Impacts
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05236127: Completed NA study, sponsored by Indiana University.
NCT05236127 is a NA study that has completed, run by Indiana University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05236127, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- OTHER Intermittent Fasting
- OTHER Soccer Heading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-01-23 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
What the finished NCT05236127 record still lists
NCT05236127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Intermittent Fasting is the first listed.
NCT05236127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05236127 about?
NCT05236127 is a clinical study titled "The Effect of Intermittent Fasting on Acute Subconcussive Head Impacts". 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...
What is the current status of trial NCT05236127?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-01-23. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT05236127?
The interventions under investigation include: Intermittent Fasting (OTHER), Soccer Heading (OTHER).
Who is sponsoring clinical trial NCT05236127?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05236127's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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