Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
NCT ID: NCT04688398
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2022-01-20
2025-03-31
Brief Summary
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Detailed Description
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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 physician
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 two research and treatment centers in Quebec: the "Groupe de recherche en rhumatologie et maladies osseuses" (GRMO Inc.) from Québec and the "Centre de recherche musculo-squelettique" (CRMS) from Centre du Québec. 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 (marine seal oil) while the other half will receive the control treatment (vegetable oil). In order to reach a minimum blood concentration of omega-3 fatty acids for measurable effects, the experimental and control treatments will be administered over a 12-week period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Seal oil
Daily intake of 15 ml of seal oil containing 534 mg of EPA + 1129 mg of DHA + 530 mg of DPA during 12 weeks
Seal oil
Consumption of seal oil once per day (at breakfast)
Control
Daily intake of vegetable oil during 12 weeks
Control
Consumption of vegetable oil once per day (at breakfast)
Interventions
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Seal oil
Consumption of seal oil once per day (at breakfast)
Control
Consumption of vegetable oil once per day (at breakfast)
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Ministry of Agriculture, Fisheries and Food, Quebec
OTHER_GOV
Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
INDUSTRY
Laval University
OTHER
Responsible Party
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Alain Doyen
Associate Professor
Principal Investigators
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Alain Doyen, PhD
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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GRMO
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019101
Identifier Type: -
Identifier Source: org_study_id
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