ADAPT Study: Marine Lipids for TMD Pain
This study, called ADAPT, is looking at whether a daily dietary supplement called SPM Precursor-Enriched Marine Lipid Supplement can help adults with chronic temporomandibular disorder (TMD) pain. TMD causes pain in your jaw, temples, or ears. You might be able to join if you are 18 or older and have had jaw pain for at least 3 months, with recent pain intensity of 30 or more on a 0-100 scale. Participants will take either the active supplement or a placebo (an inactive substance that looks the same) for 8 weeks. Researchers will measure changes in your facial pain intensity and track any side effects. This study aims to provide strong evidence on how this omega-3 supplement affects pain and quality of life.
- Study design
- This is a randomized, quadruple-masked (meaning you, your doctor, and the study staff won't know which treatment you're getting), placebo-controlled study involving 100 adults. It compares the SPM Precursor-Enriched Marine Lipid Supplement to a Medium-Chain Triglyceride Supplement (placebo).
- What's involved
- Your total participation could last up to 12 weeks, including pre-screening, 8 weeks of taking the supplement daily, and a 1-week follow-up. You will have visits at the start, at week 4, and at week 8, and will complete daily diaries about your pain.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have a safety check call one week after your final dose of the study supplement.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Marine Lipids Ease Painful TMD
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anne E Sanders, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
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What this trial measures
- Change in average weekly facial pain intensityBaseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)
Net change from baseline to Week 8 in average weekly facial pain intensity, calculated as the mean of daily entries recorded in the Daily Symptom Diary (DSD). Higher scores indicate worse pain.
- Rate of treatment-emergent adverse eventsFrom first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
Rate of participants experiencing any adverse event (AE) that first appears or worsens after starting the study intervention and up to 7 days after the last dose. Investigators record onset, duration, severity, and relatedness to the study intervention. This measure evaluates the safety of the SPM precursor marine lipid supplement compared with placebo.