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Recruiting NCT06736925

Omega-3 Fatty Acids and Subconcussive Head Impacts

No phase Interventional Subconcussive Head Impact Omega-3 Fatty Acids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omega-3 Fatty Acids (EPA plus DHA), Organic soybean oil, Soccer Heading Model.
Who it may be relevant to
Registry conditions: Subconcussive Head Impact, Omega-3 Fatty Acids. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Mechanistic Investigation of Omega-3 Fatty Acids Pretreatment Effects on Subconcussive Brain Injury

Overview

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.

Interventions

  • Dietary supplement Omega-3 Fatty Acids (EPA plus DHA)
    DHA+EPA capsules contain purified deep-sea fish oil, made from 100% wild-caught sardines and anchovies with a 3-year shelf life. The capsule shell is made from bovine limed bone with a size of 20 oblongs. Each soft gel capsule contains 480 mg of DHA, 205 mg of EPA, 145 mg of other omega-3 FA, and 10 mg of vitamin E. Participants in the DHA+EPA group will ingest 5 capsules daily \[a total of 3.4 g/d: DHA (2.4 g), EPA (1.0 g)\].
  • Dietary supplement Organic soybean oil
    We will use organic soybean oil pills ) as a placebo condition for the DHA+EPA group. One capsule contains 485 mg of organic soybean oil, including negligible amounts of DHA (1.1 mg), EPA (1.7 mg), and vitamin E (10 mg). Participants will ingest 5 capsules daily. Soybean oil is one of the most widely used vegetable oils in the world. Soybean oil contains polyunsaturated fats and 18-carbon omega-3 FA (total omega-3 FA of 73.9 mg per capsule), but very low levels of DHA and EPA, which makes it an
  • Other Soccer Heading Model
    A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer (G-force tracker) embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 30 mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Socce

Primary outcome measures

  • Blood Biomarkers [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Diffusion Tensor Imaging [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Sympathetic Reactivity [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Near Point Convergence [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • King-Devick test [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
Secondary outcome measures (8)
  • Neurite Orientation Dispersion and Density Imaging (NODDI) [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Resting-state functional connectivity [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Cardiovagal baroreflex sensitivity [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Heart rate variability [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Cognition [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Cerebral Blood Flow [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Metabolomics [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
  • Quantitative Susceptibility Mapping [Time frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Indiana University School of Public Health — Bloomington

Publications

  • Marchi N, Bazarian JJ, Puvenna V, Janigro M, Ghosh C, Zhong J, Zhu T, Blackman E, Stewart D, Ellis J, Butler R, Janigro D. Consequences of repeated blood-brain barrier disruption in football players. PLoS One. 2013;8(3):e56805. doi: 10.1371/journal.pone.0056805. Epub 2013 Mar 6. PMID 23483891
  • Kawata K, Rubin LH, Takahagi M, Lee JH, Sim T, Szwanki V, Bellamy A, Tierney R, Langford D. Subconcussive Impact-Dependent Increase in Plasma S100beta Levels in Collegiate Football Players. J Neurotrauma. 2017 Jul 15;34(14):2254-2260. doi: 10.1089/neu.2016.4786. Epub 2017 Apr 27. PMID 28181857
  • Puvenna V, Brennan C, Shaw G, Yang C, Marchi N, Bazarian JJ, Merchant-Borna K, Janigro D. Significance of ubiquitin carboxy-terminal hydrolase L1 elevations in athletes after sub-concussive head hits. PLoS One. 2014 May 7;9(5):e96296. doi: 10.1371/journal.pone.0096296. eCollection 2014. PMID 24806476
  • Oliver JM, Jones MT, Kirk KM, Gable DA, Repshas JT, Johnson TA, Andreasson U, Norgren N, Blennow K, Zetterberg H. Serum Neurofilament Light in American Football Athletes over the Course of a Season. J Neurotrauma. 2016 Oct 1;33(19):1784-1789. doi: 10.1089/neu.2015.4295. Epub 2016 Mar 16. PMID 26700106
  • Oliver JM, Anzalone AJ, Stone JD, Turner SM, Blueitt D, Garrison JC, Askow AT, Luedke JA, Jagim AR. Fluctuations in blood biomarkers of head trauma in NCAA football athletes over the course of a season. J Neurosurg. 2018 May 29;130(5):1655-1662. doi: 10.3171/2017.12.JNS172035. Print 2019 May 1. PMID 29807487
  • Shahim P, Zetterberg H, Tegner Y, Blennow K. Serum neurofilament light as a biomarker for mild traumatic brain injury in contact sports. Neurology. 2017 May 9;88(19):1788-1794. doi: 10.1212/WNL.0000000000003912. Epub 2017 Apr 12. PMID 28404801
  • Joseph JR, Swallow JS, Willsey K, Lapointe AP, Khalatbari S, Korley FK, Oppenlander ME, Park P, Szerlip NJ, Broglio SP. Elevated markers of brain injury as a result of clinically asymptomatic high-acceleration head impacts in high-school football athletes. J Neurosurg. 2018 Jul 3;130(5):1642-1648. doi: 10.3171/2017.12.JNS172386. Print 2019 May 1. PMID 29966462
  • Tierney GJ, Higgins B. The incidence and mechanism of heading in European professional football players over three seasons. Scand J Med Sci Sports. 2021 Apr;31(4):875-883. doi: 10.1111/sms.13900. Epub 2021 Jan 18. PMID 33280186

Identifiers

NCT: NCT06736925 · 21334 · R01NS137276

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗