Omega-3 Fatty Acids and Subconcussive Head Impacts

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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 \[a total of 3.4 g/d: DHA (2.4 g), EPA (1.0 g)\].
• Пищевая добавка 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
• Другое 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

Первичные конечные точки

• Blood Biomarkers [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Diffusion Tensor Imaging [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Sympathetic Reactivity [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Near Point Convergence [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• King-Devick test [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]

Вторичные конечные точки (8)

• Neurite Orientation Dispersion and Density Imaging (NODDI) [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Resting-state functional connectivity [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Cardiovagal baroreflex sensitivity [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Heart rate variability [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Cognition [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Cerebral Blood Flow [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Metabolomics [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]
• Quantitative Susceptibility Mapping [Срок оценки: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Indiana University School of Public Health — Bloomington

Публикации

• 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

Идентификаторы

NCT: NCT06736925 · 21334 · R01NS137276

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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