Recruiting

SPM Precursor

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07437313

Conditions

Temporomandibular Disorder (TMD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SPM Precursor-Enriched Marine Lipid Supplement

Medium-Chain Triglyceride Supplement

Study Details

Brief summary:

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.

Participants 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.

The study aims to evaluate whether the SPM precursor supplement:

Reduces facial pain intensity compared with placebo.

Changes pressure pain sensitivity at the jaw and other standard body sites.

Affects 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.

Participants will record their daily facial pain intensity in paper 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.

Conditions

Temporomandibular Disorder (TMD)

Study ID

NCT07437313

Start date

Sep 25, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion

Pre-screening (before Visit 0):

  • Age ≥18 years.
  • 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.
  • Pain not due to toothache or ear infection.
  • Pain intensity ≥30 on a 0-100 numeric rating scale (NRS) during the week before pre-screening.
  • Willing to provide written informed consent and follow all study procedures.
  • Able to be contacted reliably during the study period.

Visit 0 - Screening/Baseline:

  • Meets all pre-screening criteria above.
  • Examiner-confirmed TMD diagnosis (myalgia or arthralgia) per DC-TMD criteria.
  • Discontinues omega-3 supplements prior to randomization and agrees not to use them during the study.
  • Will not initiate new occlusal splint therapy during the study. Participants already using a splint ≥30 days prior may continue.
  • Maintains stable facial pain management regimen:
  • No changes to regularly scheduled daily pain medications.
  • No initiation of new facial pain treatments (pharmacologic, injectable, or non-pharmacologic).
  • Episodic prescription pain medications discontinued prior to randomization, except NSAIDs, acetaminophen, or low-dose aspirin.

Visit 1 - Randomization:

  • Completes ≥4 of 7 daily symptom diary (DSD) entries before Visit 1.
  • Average weekly pain ≥30 on 0-100 NRS, or ≥30 on at least 4 days that week.

Exclusion (Assessed at pre-screening and/or Visit 0):

  • Allergy or hypersensitivity to fish or seafood.
  • Botulinum toxin injections for facial pain within past 3 months.
  • Facial trauma or orofacial surgery within past 6 weeks.
  • History of renal failure or dialysis.
  • History of hyperthyroidism.
  • Immunocompromised state or autoimmune disorder.
  • History of seizure disorder or uncontrolled seizures.
  • Use of opioid medications in the past 30 days.
  • Pregnancy.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SPM precursor marine lipid dietary supplement

Experimental Arm - SPM Precursor Marine Lipid Supplement: Participants receive 2 g/day (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.

Placebo Arm - Medium-Chain Triglyceride (MCT) Supplement: Participants receive 2 g/day (1 g twice daily) of MCT oil softgels, identical in appearance to active supplement. Duration: 8 weeks.

placebo comparator: Medium-chain triglyceride dietary supplement

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.

Interventions

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.

Medium-Chain Triglyceride Supplement

Participants receive matched placebo softgels daily for 8 weeks.

Primary outcome measure

  • Change in average weekly facial pain intensity [ Time Frame: Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7) ]
  • Rate of treatment-emergent adverse events [ Time Frame: From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7) ]

Central Contacts and Locations

Central contacts

Anne E Sanders, PhD

(919) 246-5833adaptsms@adapt.study

Lorraine M King

(919) 246-5833adaptsms@adapt.study

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Nov 5, 2026

Last verified

Oct, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.