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Intermittent Fasting for Sports Injuries
N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least three years of soccer heading experience
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mri procedures will be performed day 4 (prior to heading) and day 7 (72 hours post-heading).
Awards & highlights
Study Summary
This trial will study the effect of fasting on the brain's response to minor head injuries sustained while playing soccer. Blood tests, MRI scans, and eye exams will be used to measure the impact of the injuries and the effect of fasting on the brain.
Eligible Conditions
- Sports Injuries
- Intermittent Fasting
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have played soccer and headed the ball for at least three years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mri procedures will be performed day 4 (prior to heading) and day 7 (72 hours post-heading).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mri procedures will be performed day 4 (prior to heading) and day 7 (72 hours post-heading).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in a panel of metabolites from day 4 to day 5 and group differences
Change in a panel of metabolites from day 4 to day 7 and group differences
Change in axonal microstructure from day 4 to day 5 and group differences
+7 moreSecondary outcome measures
Change in King Devick performance from day 0 to day 4 and group differences
Change in King Devick performance from day 4 to day 7 and group differences
Change in brain-derived blood biomarkers from day 0 to day 4 and group differences
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Pre-heading fastedExperimental Treatment1 Intervention
Pre-Heading Fasted Group: Individuals randomly assigned to undergo a 20 hour fast with a 4 hour eating window for a 5-day period prior to the soccer heading.
Group II: Post-heading fastedExperimental Treatment1 Intervention
Post-Heading Fasted Group: Individuals randomly assigned to undergo a 20 hour fast with a four hour eating window for a 3-day period following the soccer heading.
Group III: FastedExperimental Treatment1 Intervention
Fasted Group: Individuals randomly assigned to undergo a 20 hour fast with a four hour eating window for the entire 8-day period of the study.
Group IV: ControlExperimental Treatment1 Intervention
Control Group: Individuals randomly assigned to eat per usual over the course of the entire 8-day study period.
Group V: Subconcussive Head ImpactActive Control1 Intervention
All four groups undergo the same soccer heading model as described below.
Device: Soccer Heading Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 20 consecutive soccer headings, separated by 30 second intervals.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,121 Total Patients Enrolled
1 Trials studying Sports Injuries
69 Patients Enrolled for Sports Injuries
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have diabetes.You have metal implants from a recent surgery or brain implants that prevent you from having an MRI.You are currently taking medications that affect your appetite.You are pregnant.You have practiced intermittent fasting in the past 3-6 months or are currently doing it.You have a history of balance, eye, or vision problems.You have an injury that prevents you from heading the soccer ball.You have a history of an eating disorder.You had a head or eye injury within the last 12 months before the study.You have a history of neurological disorders such as seizures, head injuries with prolonged loss of consciousness, stroke, spinal cord or surgery.You must be between 18 and 30 years old.You have played soccer and headed the ball for at least three years.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-heading fasted
- Group 2: Post-heading fasted
- Group 3: Control
- Group 4: Subconcussive Head Impact
- Group 5: Fasted
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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