Omega-3 Fatty Acids and Subconcussive Head Impacts (NCT06736925) | Clinical Trial Compass
RecruitingNot Applicable
Omega-3 Fatty Acids and Subconcussive Head Impacts
United States208 participantsStarted 2025-02-28
Plain-language summary
The purpose of the proposed double-blind, randomized placebo-controlled trial is to understand how supplementation with fish oil \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] promote brain health against soccer heading. The study involves taking DHA+EPA or placebo, questionnaires, blood draws, brain imaging, tests to evaluate heart function, and soccer headings.
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:
* Between age 18-30
* Current or former soccer player
* At least 5 years of soccer heading experience
* Have internet access
* Willing to commit to avoid any sport activity that purposefully uses one's head to maneuver during the study period (American football, ice-hockey, rugby, wrestling, and soccer heading).
Exclusion Criteria:
* Any head or neck injury within 6 months before the study
* Implanted metal/magnetic devices (e.g., orthodontic braces
* Diagnosed autonomic or cardiovascular diseases (e.g., hypertension)
* Consuming oily fish (2 servings or more/month: salmon, bluefin, swordfish, anchovies)
* Allergy to fish or shellfish
* Consuming omega-3 FA supplements including plant-based (e.g., flaxseed) in the past 3 months.
* Pregnancy
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 is looking at whether omega-3 fatty acids can protect the brain from subconcussive hits — hits that don't cause a full concussion but may still cause harm over time — so could you help me understand how my current situation relates to this kind of repeated impact exposure and whether this is even relevant to my diagnosis?
2The trial is measuring things like blood biomarkers, brain imaging with diffusion tensor imaging, and eye-tracking tests like the King-Devick test — what do these measurements involve practically, and how much time and how many visits would I realistically need to commit to?
3Since this trial is listed as Phase NA, which often means it's more of an observational or early-stage study rather than a standard treatment trial, what does that mean for how much we already know about whether omega-3 supplementation actually helps, and are there any known risks I should weigh?
4The trial is testing omega-3 fatty acids, which are also available as over-the-counter supplements — is there a meaningful difference between what's being studied here and something I could just discuss starting on my own, and what would your recommendation be either way?
5Given that this trial is currently recruiting, is it worth me exploring enrollment now, or would you recommend focusing on standard care first and revisiting this kind of research option later?
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
1
Blood Biomarkers
Timeframe: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
2
Diffusion Tensor Imaging
Timeframe: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
3
Sympathetic Reactivity
Timeframe: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
4
Near Point Convergence
Timeframe: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
5
King-Devick test
Timeframe: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session