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

August 31, 2016 updated by: Ryan Bradley, National University of Natural Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One third of the America population is affected by chronic pain. The societal costs associated with chronic pain is up to $635 billion dollars annually. Prescribed pain medications may have negative side effects, or cause addictions. Having alternative treatments that can reduce inflammation and the side effects associated with chronic pain may improve the quality of life for millions.

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. SPM™ softgels are a dietary supplement intended to reduce pain and inflammation. Up to 40 men and women with chronic pain will be recruited. Outcome measures will be collected at baseline, 2 weeks, and 4 weeks with a primary endpoint of 4 weeks. The primary outcomes of this pilot study include questionnaires to assess quality of life. Exploratory outcomes assess safety and tolerability, changes in anxiety and depression as well as levels of pain, and blood markers associated with inflammation.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • National University of Natural Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
    • Kidney failure or liver failure
  • Current active pelvic inflammatory disease, urinary tract infection or a kidney infection
  • Women who are lactating, pregnant or planning pregnancy within the next six months
  • Difficulty or aversion to swallowing soft gels, capsules, tablets or pills
  • Known intolerance or allergy to fish oils
  • Upon administering the NCNM Adverse Event Monitoring form at screening, a sign or symptom of Grade 3 (severe or medically significant but not immediately life-threatening) or higher is reported
  • Currently participating in another research study or participated in another study within the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 SPM

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life through PROMIS-43
Time Frame: Four weeks
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
Time Frame: Four weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ncidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: four weeks
To assess the effect of 4 weeks of treatment with a SPM supplement on safety and tolerability will be monitored by changes in multi-system symptoms using the NCNM Adverse Event Monitoring Form.
four weeks
Depression and Anxiety PHQ-9
Time Frame: four weeks
To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the PHQ-9
four weeks
Depression and Anxiety GAD-7
Time Frame: four weeks
To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the GAD-7
four weeks
Depression and Anxiety PROMIS-43
Time Frame: four weeks
To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the PROMIS-43 Profile
four weeks
Pain
Time Frame: four weeks
Changes in pain levels, pain symptoms, pain relief, physical function, pain interference, and pain intensity and pain quality determined using the Brief Pain Inventory
four weeks
Pain
Time Frame: Four weeks
Changes in physical function, pain interference, and pain intensity the PROMIS-43 Profile subscales
Four weeks
Patient Satisfaction PSS
Time Frame: four weeks
Patient satisfaction and impression of change determined using the PSS
four weeks
Patient Satisfaction PGIC
Time Frame: four weeks
Patient satisfaction and impression of change determined using the PGIC
four weeks
Pain medication usage
Time Frame: four weeks
Changes in the use of pain medications determined using the case report form
four weeks
hs-CRP
Time Frame: four weeks
Changes in inflammatory biomarkers assessed by high-sensitivity C-reactive protein (hs-CRP)
four weeks
ESR
Time Frame: four weeks
Changes in inflammatory biomarkers assessed by erythrocyte sedimentation rate (ESR)
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Natural Medicine

Collaborators

Metagenics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 31, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091515-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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