Seal Oil for Rheumatoid Arthritis

Overseen By Louise Corneau, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must be taking: DMARDs, NSAIDs, Corticosteroids

Must not be taking: Anticoagulants, Biologicals, JAK inhibitors

Disqualifiers: Other autoimmune, IBD, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether seal oil can reduce pain and other symptoms in people with rheumatoid arthritis, a condition that causes joint inflammation. Participants will take either seal oil or vegetable oil daily for 12 weeks. Eligible participants must have had rheumatoid arthritis for at least a year, with a stable condition and low to moderate activity. The trial excludes individuals taking certain supplements or medications or those with other autoimmune diseases. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance symptom management for rheumatoid arthritis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must have a stable dose of DMARDs, NSAIDs, and corticosteroids before joining. You cannot take more than 10 mg of prednisone daily or consume certain supplements and natural health products during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that seal oil, rich in beneficial fats like EPA, DHA, and DPA, has been studied for its effects on rheumatoid arthritis symptoms. Safety checks indicate that seal oil is generally safe to consume. However, some side effects, such as longer bleeding times and stomach problems, have been noted, especially at higher doses.

Studies on the long-term safety of seal oil found it to be well-tolerated, with no major issues reported. It is important to remember that while seal oil appears promising, it is still under investigation. Prospective trial participants should consider these possible side effects to make an informed choice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for rheumatoid arthritis, which often include medications like NSAIDs, corticosteroids, and DMARDs, seal oil offers a unique approach by harnessing the power of omega-3 fatty acids. This treatment stands out because it combines EPA, DHA, and DPA, which are known for their anti-inflammatory properties. Researchers are excited about seal oil's potential to reduce inflammation naturally, possibly leading to fewer side effects compared to traditional medications. Additionally, the convenience of a daily intake makes it an appealing alternative for those seeking a more natural, dietary-based intervention.

What evidence suggests that seal oil might be an effective treatment for rheumatoid arthritis?

Research has shown that seal oil, rich in omega-3 fatty acids like EPA, DHA, and DPA, might help reduce rheumatoid arthritis symptoms. These fatty acids decrease inflammation, a major issue in rheumatoid arthritis. In this trial, participants will receive either seal oil or a control treatment. One study found that fish oil, similar to seal oil, significantly reduced the number of tender joints in patients after three months. Another study discovered that omega-3-rich seal oil can decrease the production of substances in the body that cause inflammation. Although direct evidence for seal oil is limited, these findings suggest it might help manage pain and inflammation in rheumatoid arthritis. ^{2 6 7 8 9}

Who Is on the Research Team?

Alain Doyen, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

This trial is for adults who've had rheumatoid arthritis (RA) for at least a year, meet specific RA criteria, and have low to moderate disease activity. Participants must be on stable doses of certain RA medications and not consume much fish or omega-3 supplements. Those with severe osteoarthritis, other autoimmune diseases, seafood allergies, fibromyalgia, or taking anticoagulants can't join.

Inclusion Criteria

I have had rheumatoid arthritis for at least one year.

Meet the 2010 ACR/EULAR criteria

I have been on a stable dose of my rheumatism medication for at least 3 months.

Exclusion Criteria

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

I have been diagnosed with inflammatory bowel disease.

I have been treated with drugs targeting JAK enzymes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily intake of 15 ml of seal oil or vegetable oil for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Seal oil

Trial Overview

The study tests the effects of seal oil rich in DPA (a type of fatty acid) on reducing symptoms like pain in people with rheumatoid arthritis. It's a controlled study where participants are randomly assigned to receive either seal oil or a control substance to compare outcomes.

How Is the Trial Designed?

Group I: Seal oil Experimental Treatment 1 Intervention

Daily intake of 15 ml of seal oil containing 534 mg of EPA + 1129 mg of DHA + 530 mg of DPA during 12 weeks

Group II: Control Active Control 1 Intervention

Daily intake of vegetable oil during 12 weeks

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Ministry of Agriculture, Fisheries and Food, Quebec

Collaborator

Trials

4

Recruited

450+

Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.

Industry Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

Dietary supplementation with n-3 polyunsaturated fatty acids (PUFA), such as fish oils, shows a modest beneficial effect on disease parameters in patients with active rheumatoid arthritis, based on a review of ten double-blind studies.

The studies indicated that fish oil supplementation does not lead to serious side effects, suggesting it is a safe adjunct treatment, but further long-term research is needed to explore optimal dosages and its effects in combination with standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis]. Ernst, E., Nielsen, GL., Schmidt, EB.[2006]

Marine n-3 polyunsaturated fatty acids (PUFAs), such as EPA and DHA, have been shown to provide a modest benefit in reducing joint swelling, pain, and morning stiffness in patients with rheumatoid arthritis (RA), based on a systematic review of 23 studies.

These fatty acids work by decreasing the levels of inflammatory eicosanoids derived from arachidonic acid, suggesting a mechanism of action that helps to alleviate inflammation and improve overall disease activity in RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis. Miles, EA., Calder, PC.[2018]

A study involving 324 women with rheumatoid arthritis and 1,245 controls found that consuming broiled or baked fish is linked to a reduced risk of developing rheumatoid arthritis, with adjusted odds ratios indicating a significant protective effect.

The protective association was particularly strong among women who tested positive for rheumatoid factor, suggesting that omega-3 fatty acids from fish may play a role in preventing this autoimmune disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and rheumatoid arthritis in women: a possible protective effect of fish consumption. Shapiro, JA., Koepsell, TD., Voigt, LF., et al.[2019]

In a clinical trial with 67 patients suffering from active rheumatoid arthritis, those receiving omega-3 fatty acids along with naproxen showed significant improvements in morning stiffness and overall health assessments compared to those on placebo and naproxen.

Patients who received omega-3 fatty acids alone experienced a deterioration in symptoms, but the deterioration was less severe when combined with naproxen, suggesting that omega-3 supplementation may enhance the effects of traditional anti-inflammatory medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. Kjeldsen-Kragh, J., Lund, JA., Riise, T., et al.[2013]

In a study of patients with early rheumatoid arthritis (RA) who were new to disease-modifying anti-rheumatic drugs (DMARDs), high-dose fish oil (5.5 g/day) significantly reduced the failure rate of triple DMARD therapy compared to a low-dose control group (0.4 g/day), with a hazard ratio of 0.28, indicating a strong protective effect.

Patients receiving high-dose fish oil also had a significantly higher rate of achieving remission according to the American College of Rheumatology criteria, with a hazard ratio of 2.17, suggesting that fish oil may enhance the effectiveness of standard RA treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use. Proudman, SM., James, MJ., Spargo, LD., et al.[2018]

In a study of 43 rheumatoid arthritis patients taking 10 g/day of fish oil, those in the fish oil group showed a significant decrease in NSAID consumption and improved global arthritic activity after 3 months, suggesting some therapeutic benefits.

Despite these improvements, fish oil did not significantly change pain levels, morning stiffness, or functional capacity, indicating that while it may have small anti-inflammatory effects, its overall impact on symptoms is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of six months of fish oil supplementation in stable rheumatoid arthritis. A double-blind, controlled study. Sköldstam, L., Börjesson, O., Kjällman, A., et al.[2019]

In a trial involving 16 patients with rheumatoid arthritis, dietary supplementation with fish oil significantly reduced joint swelling and the duration of early morning stiffness compared to a placebo, indicating its efficacy in managing symptoms.

Fish oil supplementation led to increased levels of beneficial fatty acids (eicosapentaenoic acid and docosahexaenoic acid) in the body and reduced the production of inflammatory compounds, suggesting a mechanism of action that may help alleviate rheumatoid arthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of fish oil supplementation in rheumatoid arthritis. van der Tempel, H., Tulleken, JE., Limburg, PC., et al.[2022]

In a study involving 51 patients with active rheumatoid arthritis, dietary supplementation with n-3 polyunsaturated fatty acids (n-3 PUFA) for 12 weeks led to small but significant improvements in morning stiffness, joint tenderness, and C-reactive protein levels.

The supplementation was found to be safe, with no serious side effects reported, although it only had a modest effect on a few disease variables and did not impact other traditional measures of disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis. A randomized and double-blind study]. Faarvang, KL., Nielsen, GL., Thomsen, BS., et al.[2006]

A meta-analysis and re-analysis of data from 395 patients confirmed that fish oil supplementation significantly reduces tender joint count and morning stiffness in rheumatoid arthritis patients after 3 months of treatment.

The study highlights the benefits of using fish oil as a dietary supplement for improving symptoms of rheumatoid arthritis, with significant reductions in joint tenderness and stiffness compared to control oils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. Fortin, PR., Lew, RA., Liang, MH., et al.[2019]

Citations

1.

ctv.veeva.com

ctv.veeva.com/study/study-of-the-impact-of-fatty-acids-from-seal-oil-on-the-relief-of-symptoms-associated-with-rheumatoi

Study of the Impact of Fatty Acids From Seal Oil on the Relief ...

The main objective of this project is to measure the efficacy of DPA-rich marine seal oil in improving the clinical signs and symptoms ...

2.

withpower.com

withpower.com/trial/phase-arthritis-8-2021-c9821

Seal Oil for Rheumatoid Arthritis

This trial tests if sea bass oil rich in DPA can reduce pain and inflammation in people with rheumatoid arthritis. The study involves 130 patients who will ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/7490601/

Validation of a meta-analysis: the effects of fish oil in ... - PubMed

The meta-analysis demonstrated that dietary fish oil supplementation for 3 months significantly reduced tender joint count.

4.

examine.com

examine.com/research-feed/study/9ox4Gd/?srsltid=AfmBOoq4aVfdg6g9DHvXQrk3BFpcr8d41KctvktsenoaPpXRzHFWn0gm

Does seal oil improve blood lipids? - Study Summary

In this meta-analysis of 9 randomized controlled trials in 626 participants, supplementation with seal oil had no clinically meaningful effects on blood lipids.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4500520/

Effects of Omega-3-Rich Harp Seal Oil on the Production of ...

These observations demonstrate that omega-3-rich harp seal oil downregulates the production of the pro-inflammatory cytokines such as IL-1β, TNF-α, and IL-12/IL ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6917585/

Marine oil supplements for rheumatoid arthritis - PMC

Potential harms of marine oil supplementation, particularly at high doses, include prolonged bleeding time, gastrointestinal intolerance, contamination with ...

7.

webprod.hc-sc.gc.ca

webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=seal.oil3&lang=eng

SEAL OIL

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural ...

8.

arcjournals.org

arcjournals.org/pdfs/ijrsb/v9-i1/3.pdf

Safety Evaluation of Seal Oil and its Lipid-Lowering Effect ...

In order to further studying the safety of seal oil for long-term consumption and its lipid-lowering function, we carried out two tests on seal oil: the first ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5295086/

Marine Oil Supplements for Arthritis Pain: A Systematic ...

The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.