Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
This project proposes to conduct the first ever clinical study demonstrating the impact of
 DPA-rich sea bass oil compared to regular fish oil without DPA on the reduction of symptoms
 related to rheumatoid arthritis. This unique approach will allow to clinically evaluate the
 benefits of sea bass oil on the relief of rheumatoid arthritis-related pain in a population
 suffering from inflammatory arthritis.
The main objective of this project is to measure the efficacy of DPA-rich marine wolfish oil
 compared to a DPA-free marine oil in improving the clinical signs and symptoms associated
 with rheumatoid arthritis through the score calculated from the Rheumatoid Arthritis Disease
 Activity Index (RADAI) questionnaire, in patients suffering from this disease.

 The secondary objectives are to evaluate the effect of DPA-rich seal oil on:

 1. the degree of disease activity as measured by a joint examination performed by the
 doctor

 2. the patient's overall health, quality of life and level of fatigue

 3. blood biomarkers of inflammation (CRP: c-reactive protein, TNF-: tumor necrosis factor,
 IL-1, IL-6 and IL-17: interleukin);

 4. the use of non-steroidal anti-inflammatory drugs (NSAIDs);

 5. the occurrence of side effects.

 To do so, the proposed study is a multi-center, randomized, double-blind, parallel-designed
 study involving 130 participants with a previous diagnosis of RA from three research and
 treatment centers in Quebec: the Centre de l'ostéoporose et de rhumatologie de Québec, the
 Clinique de rhumatologie/physiatrie du Centre du Québec and the Institut de rhumatologie de
 Montréal. Rheumatologists from each of the centers, as well as research nurses, will be
 involved in this project, which will be coordinated by a research professional from the
 Institut sur la nutrition et les aliments fonctionnels (INAF) at Université Laval. Half of
 the participants (n=65) will randomly receive the experimental treatment while the other half
 will receive the control treatment. In order to reach a minimum blood concentration of DPA
 for measurable effects, the experimental and control treatments will be administered over a
 12-week period.
Inclusion Criteria:

 -  Have been diagnosed with RA after the age of 18;

 -  Have had RA for at least 1 year;

 -  Meet the 2010 ACR/EULAR criteria;

 -  Stable disease status for at least 3 months:

 -  Low to moderate activity as measured by the Clinical Disease Activity Index
 (CDAI);

 -  Stable dose of DMARD (conventional synthetic Disease Modifying Anti-Rheumatic
 Drug) for at least 3 months;

 -  Stable dose of NSAIDs and corticosteroids for at least 1 month;

 -  Do not take > 10 mg per day of prednisone.

 Exclusion Criteria:

 -  Have been diagnosed with another rheumatologic autoimmune disease;

 -  Have been diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's
 disease);

 -  Have a disease that may interfere with the physician's assessment (e.g. severe
 osteoarthritis);

 -  Have fibromyalgia;

 -  Consume omega-3 fatty acid supplements other than those given during the project;

 -  Have an allergy or intolerance to seafood;

 -  Consume natural health products that may potentially affect inflammation (e.g.
 glucosamine, chondroitin, devil's claw, curcumin products) during the project;

 -  Consume more than two servings (1 serving = 90 g or 3 ounces) of fish and seafood per
 week for the duration of the study;

 -  Take anticoagulant medication;

 -  Be treated or have previously received biological agents or inhibitors of JAK (Janus
 kinase) (family of tyrosine kinases).