Influence of an Omega-3 SPM Supplement on Quality of Life

NCT02683850 | Completed Early Phase 1

• 1 other identifier: 091515-B
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft gel supplement for four weeks will increase the quality of life in adults with chronic pain.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Quality of Life through PROMIS-43

  To assess the effect of 4 weeks of treatment with a SPM supplement on quality of life in a chronic pain population using the PROMIS-43 Profile (including PROMIS-43 subscales addressing physical function, fatigue, and sleep disturbance, ability to participate in social roles and activities).

  Four weeks

• Quality of Life ACPA

  To assess the effect of 4 weeks of treatment with a SPM supplement on quality of life in a chronic pain population using American Chronic Pain Association's Quality of Life Scale.

  Four weeks

Other Outcomes (11)

• ncidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  four weeks

• Depression and Anxiety PHQ-9

  four weeks

• Depression and Anxiety GAD-7

  four weeks

Study Arms (1)

Omega-3 SPM

EXPERIMENTAL

Intervention: Study participants will be instructed to take 3 Omega-3 SPM™ softgel supplements in the morning and 3 Omega-3 SPM™ soft gel supplements in the evening for two weeks. At weeks two participants whose PROMIS-43 Pain Intensity score indicates a reduction in pain levels weeks, will take 2 Omega-3 SPM™ soft gel supplements in the morning and 2 in the evening for the remaining 2 weeks of the study. Participants whose PROMIS-43 Pain Intensity score remained the same after two weeks, or increased will take 4 Omega-3 SPM™ soft gel supplements in the morning and 4 SPM™ softgels in the evening for the remaining two weeks of the study.

Dietary Supplement: Omega-3 SPM™ softgel

Interventions

Omega-3 SPM™ softgel DIETARY_SUPPLEMENT

This four week, prospective, non-randomized, open-label study is assessing the impact on quality of life from taking an Omega-3 SPM™ softgel supplement in adults with pain symptoms at screening of 4 or higher on the PROMIS-43 Profile - Pain Intensity subscale.

Omega-3 SPM

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-70
• Body mass index 19 kg/m2 - 40 kg/m2
• Have had chronic pain lasting 3 months or longer
• Have moderate to severe pain as define by an average level of pain score of greater than or equal to a 4 on the PROMIS-43 Profile - Pain Intensity subscale
• Willing to have blood drawn three times
• Maintained stable medications, dietary supplements and therapies for pain for at least 30 days and willing to continue the same therapies and not add new therapies for the duration of the study unless medically advised to do so
• Able to follow study protocol and attend visits at the clinical practices associated with Clinical Investigator
• Able to speak, read and understand English

You may not qualify if:

• Initiation of or changes in use of fish oil supplements, krill oil supplements, omega 3 supplements, or omega 3-based drugs (Lovaza®, etc.) within the past 3 months
• Initiation of new pain medications and non-steroidal anti-inflammatory drugs NSAIDS within the past month such as \[aspirin, ibuprofen (Advil®, Motrin®, Nuprin®), acetaminophen (Tylenol®), naproxen (Aleve®, Naprosyn®), codeine (Vicodin®), morphine (Dilaudid®), oxycodone (OxyContin®, Percocet®) fentanyl (Duragesic®) and COX-2 inhibitors, Celebrex®)
• Currently taking:
• Medication to reduce the tendency to form blood clots such as \[warfarin, jantoven (Coumadin®); dabigatran (Pradaxa®); rivaroxaban, (Xarelto®); apixaban (Eliquis®)\]
• Statin use for cholesterol reduction such as \[atorvastatin (Lipitor®), fluvastatin (Lescol®), lovastatin (Mevacor®, Altocor®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®) or simvastatin (Zocor®)\] (not including Red Yeast Rice if also supplementing with CoQ10)
• Corticosteroids such as \[prednisone, dexamethasone, prednisolone (Orapred®, Prelone®, Pediapred®), methylprednisolone (Medrol®)\] (not including topical corticosteroids for dermatological conditions or nasally inhaled for asthma, rhinitis or sinusitis)
• Daily aspirin \>325 mg per day (not including low dose aspirin therapy of 81 mg - 325 mg per day)
• Other medications and supplements to be evaluated by the investigators on a case-by-case basis
• Steroid injections, Prolotherapy, or other injections into a ligament, tendon, joint or muscle during the past month or initiation or continuation of therapy injections during the course of the study.
• Present or past history of any of the following:
• Inflammatory disease (e.g. rheumatoid arthritis, autoimmune disease, Crohn's disease, diverticulitis, viral hepatitis, ulcerative colitis, systemic lupus, Parkinson's disease, Alzheimer's, ankylosing spondylitis)
• Blood clot disorder (e.g., phlebitis)
• Diabetes (self-report; includes Type I and Type II Diabetes but does not include a history of Gestational Diabetes during pregnancy)
• Cancer within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
• Cardiovascular disease within the last year, including but not limited to: myocardial infarction, stroke, congestive heart failure (CHF)

Sponsors & Collaborators

• National University of Natural Medicine: lead
• Metagenics, Inc.: collaborator

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

Related Publications (11)

• Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.

  PMID: 23800144 BACKGROUND

• Ussai S, Miceli L, Pisa FE, Bednarova R, Giordano A, Della Rocca G, Petelin R. Impact of potential inappropriate NSAIDs use in chronic pain. Drug Des Devel Ther. 2015 Apr 9;9:2073-7. doi: 10.2147/DDDT.S80686. eCollection 2015.

  PMID: 25926717 BACKGROUND

• Reuben DB, Alvanzo AA, Ashikaga T, Bogat GA, Callahan CM, Ruffing V, Steffens DC. National Institutes of Health Pathways to Prevention Workshop: the role of opioids in the treatment of chronic pain. Ann Intern Med. 2015 Feb 17;162(4):295-300. doi: 10.7326/M14-2775.

  PMID: 25581341 BACKGROUND

• Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.

  PMID: 25581257 BACKGROUND

• Maroon JC, Bost JW. Omega-3 fatty acids (fish oil) as an anti-inflammatory: an alternative to nonsteroidal anti-inflammatory drugs for discogenic pain. Surg Neurol. 2006 Apr;65(4):326-31. doi: 10.1016/j.surneu.2005.10.023.

  PMID: 16531187 BACKGROUND

• Serhan CN. Pro-resolving lipid mediators are leads for resolution physiology. Nature. 2014 Jun 5;510(7503):92-101. doi: 10.1038/nature13479.

  PMID: 24899309 BACKGROUND

• Serhan CN, Chiang N, Van Dyke TE. Resolving inflammation: dual anti-inflammatory and pro-resolution lipid mediators. Nat Rev Immunol. 2008 May;8(5):349-61. doi: 10.1038/nri2294.

  PMID: 18437155 BACKGROUND

• Colas RA, Shinohara M, Dalli J, Chiang N, Serhan CN. Identification and signature profiles for pro-resolving and inflammatory lipid mediators in human tissue. Am J Physiol Cell Physiol. 2014 Jul 1;307(1):C39-54. doi: 10.1152/ajpcell.00024.2014. Epub 2014 Apr 2.

  PMID: 24696140 BACKGROUND

• Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.

  PMID: 18055266 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

• Callan N, Hanes D, Bradley R. Early evidence of efficacy for orally administered SPM-enriched marine lipid fraction on quality of life and pain in a sample of adults with chronic pain. J Transl Med. 2020 Oct 21;18(1):401. doi: 10.1186/s12967-020-02569-5.

  PMID: 33087142 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Bradley, ND, MPH

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of Research

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 17, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)