[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572719":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":25,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Indiana University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo: Organic soybean oil pills","PLACEBO_COMPARATOR","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 excellent placebo counterpart when evaluating the effects of DHA\u002FEPA. The placebo capsule's shelf life, composition, shape, size as the DHA+EPA active comparator.",[13,14],"Dietary Supplement: Organic soybean oil","Other: Soccer Heading Model",{"label":16,"type":17,"description":18,"interventionNames":19},"Omega-3 Fatty Acids (EPA plus DHA)","ACTIVE_COMPARATOR","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\u002Fd: DHA (2.4 g), EPA (1.0 g)\\].",[20,14],"Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA)",[22,26,29],{"type":23,"name":16,"description":18,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT",[16],null,{"type":23,"name":27,"description":11,"armGroupLabels":28,"otherNames":25},"Organic soybean oil",[9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":25},"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. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air.",[16,9],[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Kei Kawata","CONTACT","812-855-5244","kkawata@indiana.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Indiana University School of Public Health","RECRUITING","Bloomington","Indiana","47405","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-86.52639,39.16533,{"lat":52,"lon":51},[55,56],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":35,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Keisuke Kawata","Associate Professor",[62],{"name":63,"class":64},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100572719","omega-3-fatty-acids-and-subconcussive-head-impacts-100572719",false,"NCT06736925","Omega-3 Fatty Acids and Subconcussive Head Impacts","Mechanistic Investigation of Omega-3 Fatty Acids Pretreatment Effects on Subconcussive Brain Injury","Inclusion Criteria:\n\n* Between age 18-30\n* Current or former soccer player\n* At least 5 years of soccer heading experience\n* Have internet access\n* 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).\n\nExclusion Criteria:\n\n* Any head or neck injury within 6 months before the study\n* Implanted metal\u002Fmagnetic devices (e.g., orthodontic braces\n* Diagnosed autonomic or cardiovascular diseases (e.g., hypertension)\n* Consuming oily fish (2 servings or more\u002Fmonth: salmon, bluefin, swordfish, anchovies)\n* Allergy to fish or shellfish\n* Consuming omega-3 FA supplements including plant-based (e.g., flaxseed) in the past 3 months.\n* Pregnancy",true,"ALL","18 Years","30 Years",{"count":77,"type":78},208,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84,85],"Subconcussive Head Impact","Omega-3 Fatty Acids",[87,88,89,90],"Subconcussive brain injury","TBI","Soccer heading","Omega-3 fatty acids","2026-04-28",{"date":93,"type":94},"2026-04-29","ACTUAL",{"date":96,"type":94},"2025-02-28",{"date":98,"type":78},"2029-05-31",{"name":5,"class":6},1]