[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626567":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":54,"collaborators":56,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":103,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SPM precursor marine lipid dietary supplement","EXPERIMENTAL","Experimental Arm - SPM Precursor Marine Lipid Supplement: Participants receive 2 g\u002Fday (1 g twice daily) of SPM Active® softgels containing 18-HEPE, 17-HDHA, and 14-HDHA. Softgels are identical in appearance to placebo. Duration: 8 weeks.\n\nPlacebo Arm - Medium-Chain Triglyceride (MCT) Supplement: Participants receive 2 g\u002Fday (1 g twice daily) of MCT oil softgels, identical in appearance to active supplement. Duration: 8 weeks.",[13],"Dietary Supplement: SPM Precursor-Enriched Marine Lipid Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Medium-chain triglyceride dietary supplement","PLACEBO_COMPARATOR","Participants receive 2 grams per day of a placebo supplement, administered as medium-chain triglyceride (MCT) oil softgels. Participants take 1 gram orally twice daily for 8 weeks. The placebo softgels are identical in appearance and packaging to the active supplement. Participants remain in this arm for the full duration of the study.",[19],"Dietary Supplement: Medium-Chain Triglyceride Supplement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","SPM Precursor-Enriched Marine Lipid Supplement","Participants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Medium-Chain Triglyceride Supplement","Participants receive matched placebo softgels daily for 8 weeks.",[15],[32],{"name":33,"affiliation":5,"role":34},"Anne E Sanders, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","919-537-3275","anne_sanders@unc.edu",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-79.05584,35.9132,{"lat":52,"lon":51},{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57,60],{"name":58,"class":59},"Metagenics, Inc.","INDUSTRY",{"name":61,"class":62},"National Institute of Dental and Craniofacial Research (NIDCR)","NIH","100626567","marine-lipids-ease-painful-tmd-100626567",false,"NCT07437313","Marine Lipids Ease Painful TMD","Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain","ADAPT","Inclusion\n\nPre-screening (before Visit 0):\n\n* Age ≥18 years.\n* Pain in jaws, temples, ears, or in front of ears at least 5 days in the past 30 days, occurring monthly over the last 3 months.\n* Pain not due to toothache or ear infection.\n* Pain intensity ≥30 on a 0-100 numeric rating scale (NRS) during the week before pre-screening.\n* Willing to provide written informed consent and follow all study procedures.\n* Able to be contacted reliably during the study period.\n\nVisit 0 - Screening\u002FBaseline:\n\n* Meets all pre-screening criteria above.\n* Examiner-confirmed TMD diagnosis (myalgia or arthralgia) per DC-TMD criteria.\n* Discontinues omega-3 supplements prior to randomization and agrees not to use them during the study.\n* Will not initiate new occlusal splint therapy during the study. Participants already using a splint ≥30 days prior may continue.\n* Maintains stable facial pain management regimen:\n* No changes to regularly scheduled daily pain medications.\n* No initiation of new facial pain treatments (pharmacologic, injectable, or non-pharmacologic).\n* Episodic prescription pain medications discontinued prior to randomization, except NSAIDs, acetaminophen, or low-dose aspirin.\n\nVisit 1 - Randomization:\n\n* Completes ≥4 of 7 daily symptom diary (DSD) entries before Visit 1.\n* Average weekly pain ≥30 on 0-100 NRS, or ≥30 on at least 4 days that week.\n\nExclusion (Assessed at pre-screening and\u002For Visit 0):\n\n* Allergy or hypersensitivity to fish or seafood.\n* Botulinum toxin injections for facial pain within past 3 months.\n* Facial trauma or orofacial surgery within past 6 weeks.\n* History of renal failure or dialysis.\n* History of hyperthyroidism.\n* Immunocompromised state or autoimmune disorder.\n* History of seizure disorder or uncontrolled seizures.\n* Use of opioid medications in the past 30 days.\n* Pregnancy.","ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","The ADAPT study is a single-site, Phase 2b, randomized, quadruple-masked, placebo-controlled trial evaluating an omega-3 dietary supplement enriched with specialized pro-resolving mediator (SPM) precursors in adults with chronic temporomandibular disorder (TMD) pain. The trial will enroll 100 adults aged 18 years or older with examiner-confirmed TMD myalgia or arthralgia will be enrolled at the University of North Carolina at Chapel Hill, Adams School of Dentistry.\n\nParticipants are randomized 1:1 to receive either the SPM precursor supplement or a matched placebo daily for 8 weeks. Randomization is stratified by sex, and study agents are identical in appearance to maintain masking.\n\nThe study aims to evaluate whether the SPM precursor supplement:\n\nReduces facial pain intensity compared with placebo.\n\nChanges pressure pain sensitivity at the jaw and other standard body sites.\n\nAffects other aspects of chronic pain, including duration, interference with daily activities, headache burden, anxiety, depression, jaw-related quality of life, and overall patient-reported change.\n\nParticipants will record their daily facial pain intensity in electronic diaries, complete short questionnaires at baseline, Week 4, and Week 8, and undergo experimental pain testing with a handheld algometer at baseline, Week 4, and Week 8. Safety is monitored through the documentation of all adverse events throughout the study period.",[81],"Temporomandibular Disorder (TMD)",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"Chronic facial pain","Temporomandibular joint pain","TMD myalgia","TMD arthralgia","Orofacial pain","Specialized pro-resolving mediators (SPMs)","Omega-3 fatty acids","Marine lipid supplement","Dietary supplement intervention","Pressure pain sensitivity","Experimental pain testing","Central sensitization","Chronic pain mechanisms","Randomized controlled trial","Pain interference","Headache impact","Anxiety and depression in chronic pain","Quality of life","Migraine","Body pain distribution","NOT_YET_RECRUITING","2026-02-20",{"date":106,"type":107},"2026-02-27","ACTUAL",{"date":109,"type":75},"2026-08",{"date":111,"type":75},"2030-12",{"name":5,"class":6},1]