NCT04688398

Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project proposes to conduct the first fully controlled and randomized clinical study demonstrating the impact of DPA-rich sea bass oil 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.

Detailed description

The main objective of this project is to measure the efficacy of DPA-rich marine seal 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 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

• Polyarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Seal oil	Consumption of seal oil once per day (at breakfast)
DIETARY_SUPPLEMENT	Control	Consumption of vegetable oil once per day (at breakfast)

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-08-31
• Completion: 2025-03-31
• First posted: 2020-12-30
• Last updated: 2024-03-15

Locations

1 site across 1 country: Canada