Clinical trial NCT06736925: Omega-3 Fatty Acids and Subconcussive Head Impacts
Official title: Mechanistic Investigation of Omega-3 Fatty Acids Pretreatment Effects on Subconcussive Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subconcussive Head Impact
Omega-3 Fatty Acids
Keywords: Subconcussive brain injury
TBI
Soccer heading
Omega-3 fatty acids
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-12-17
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be randomly assigned to take DHA+EPA, while the other group will be randomly assigned to take the placebo, organic soybean oil. Both groups will received identical stimuli of 20 soccer headings per session for a total of 2 sessions.
Primary purpose: PREVENTION

Brief 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.

Detailed description: The purpose of the proposed study is to determine whether, and to what extent, supplementation with omega-3 fatty acids \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] can maintain or promote neural wellbeing against repetitive subconcussive head impacts. This study will also characterize what aspects of brain cellular and physiologic resiliencies are enhanced by supplementation in adult soccer players (aged 18-30 years old). A sub-cohort of participants who meet criteria for ADHD diagnosis will be part of exploratory analysises.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Biomarkers
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Diffusion Tensor Imaging
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Sympathetic Reactivity
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Near Point Convergence
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: King-Devick test
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
Secondary outcomes:
measure: Neurite Orientation Dispersion and Density Imaging (NODDI)
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Resting-state functional connectivity
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Cardiovagal baroreflex sensitivity
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Heart rate variability
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Cognition
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Cerebral Blood Flow
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Metabolomics
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
measure: Quantitative Susceptibility Mapping
timeFrame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session
Other outcomes:
measure: Genetic markers
timeFrame: Baseline
measure: ADHD
timeFrame: Baseline
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Public Health
state: Indiana
Study officials:
References:
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