Recruiting

Seal Oil

Sponsor:

Laval University

Code:

NCT04688398

Conditions

Polyarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Seal oil

Control

Study Details

Brief 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.

Conditions

Polyarthritis

Study ID

NCT04688398

Start date

Jan 20, 2022

Status verified date

Mar, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: Control

Daily intake of vegetable oil during 12 weeks

Interventions

Seal oil

Consumption of seal oil once per day (at breakfast)

Control

Consumption of vegetable oil once per day (at breakfast)

Primary outcome measure

  • Efficacy of DPA-rich seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis [ Time Frame: One year after the beginning of the study ]

Central Contacts and Locations

Central contacts

Louise Corneau, MSc

418-656-2131louise.corneau@fsaa.ulaval.ca

Sonia Pomerleau, MSc

418-656-2131sonia.pomerleau@fsaa.ulaval.ca

Locations

GRMO

Recruiting

Québec, Canada, G1V 3M7

Contacts

Chantal Jacques

418-650-0698chantal.jacques@grmo.ca

More Information

Sponsor

Laval University

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • seal oil
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2024-03-15.