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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 is a NA study that has completed, run by Indiana University. The registered enrollment target is 40 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05236127
The ClinicalTrials.gov registry entry for NCT05236127 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intermittent Fasting is the first listed.
NCT05236127 reports 0 study locations.
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.
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