Marine Lipid Supplement for Jaw Pain
(ADAPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a marine lipid supplement, enriched with specialized compounds, can reduce jaw pain in people with chronic temporomandibular disorder (TMD). Participants will take either the SPM Precursor-Enriched Marine Lipid Supplement or a placebo to determine if it lessens facial pain and improves quality of life. Ideal candidates are adults who have experienced jaw pain at least five days a month over the past three months, excluding those with pain from toothaches or ear infections.
As an unphased trial, this study provides an opportunity to contribute to understanding new potential treatments for TMD.
Do I have to stop taking my current medications for the trial?
You can continue your current facial pain medications as long as they are stable and regularly scheduled. However, you must stop taking omega-3 supplements before the trial and cannot start new facial pain treatments during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the SPM precursor marine lipid supplement is generally safe and well-tolerated. In one study, participants reported no side effects from taking the supplement. They took 500 mg softgels, similar to those used in the current trial. Another study found that individuals who took the supplement experienced reduced soreness and joint discomfort over time. These findings suggest that the supplement is likely safe for people, with few reported side effects.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the SPM Precursor-Enriched Marine Lipid Supplement for jaw pain because it targets inflammation differently than standard treatments like NSAIDs or corticosteroids. This supplement contains special compounds called 18-HEPE, 17-HDHA, and 14-HDHA, which are types of specialized pro-resolving mediators (SPMs). These SPMs help to naturally reduce inflammation and promote healing without the common side effects associated with traditional pain medications. By using these unique marine-derived ingredients, the supplement may offer a safer, more natural alternative for managing jaw pain.
What evidence suggests that the SPM precursor-enriched marine lipid supplement might be an effective treatment for jaw pain?
Research has shown that a marine oil supplement enriched with SPM precursors might help reduce pain and improve life quality for people with chronic pain. Studies have found that these supplements, which contain compounds like 17-HDHA and 18-HEPE, can lessen soreness and joint discomfort. In one study, participants felt 36% less sore after just two weeks, with noticeable improvements in pain and tissue healing. Another study demonstrated that levels of these special compounds in the blood increased within hours, indicating a quick response in the body. This trial will compare the SPM Precursor-Enriched Marine Lipid Supplement with a placebo, a Medium-Chain Triglyceride Supplement, to evaluate its effectiveness for managing jaw pain from temporomandibular disorder (TMD).12367
Who Is on the Research Team?
Anne E Sanders, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who have had jaw, temple, or ear pain at least 5 days a month over the past 3 months and are diagnosed with chronic temporomandibular disorder (TMD) myalgia or arthralgia. Participants must stop any omega-3 supplements before joining and not have pain from toothache or ear infection.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the SPM precursor supplement or placebo daily for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Medium-Chain Triglyceride Supplement
- SPM Precursor-Enriched Marine Lipid Supplement
Trial Overview
The study tests whether an omega-3 supplement enriched with SPM precursors can reduce facial pain in people with TMD compared to a placebo. Participants are randomly assigned to take either the supplement or placebo daily for 8 weeks, without knowing which one they receive.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Metagenics, Inc.
Industry Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Metagenics LLC
Collaborator
Citations
NCT07437313 | Marine Lipids Ease Painful TMD
The study aims to evaluate whether the SPM precursor supplement: Reduces facial pain intensity compared with placebo. Changes pressure pain ...
Early evidence of efficacy for orally administered SPM ... - PMC
We conclude that oral supplementation with a fractionated marine lipid concentration standardized to 17-HDHA and 18-HEPE may improve quality of life.
Marine Lipid Supplement for Jaw Pain (ADAPT Trial)
The ADAPT study is a single-site, Phase 2b, randomized, quadruple-masked, placebo-controlled trial evaluating an omega-3 dietary supplement ...
SPM Precursor-Enriched Marine Lipid Supplement and Medium ...
The ADAPT study is a single-site, Phase 2b, randomized, quadruple-masked, placebo-controlled trial evaluating an omega-3 dietary supplement enriched with ...
Early evidence of efficacy for orally administered SPM ...
We conclude that oral supplementation with a fractionated marine lipid concentration standardized to 17-HDHA and 18-HEPE may improve quality of life.
6.
fullscript.com
fullscript.com/wp-content/uploads/2024/04/NEW-SPM-Active-Detail-Aid-LIT0560METUS.pdfSPM Active®
Do not use if safety seal is missing or broken. Form: 60 Softgels, 120 Softgels. Serving size: 2 Softgels. Calories. 10. Total Fat. 1 g.
7.
metagenics.com
metagenics.com/en-us/product/spm-active?srsltid=AfmBOopkH8ojOjzd3U4vUkW4CA_i1yuyd8V4Auo_EWjuBhtg46CO2Zb0SPM Active
Targets soreness at the source, not just the symptoms* · 36% felt less sore in 2 weeks; 81% less joint discomfort at 3 months* · Eases everyday soreness and ...
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