Improving nutrition for patients with rheumatic diseases
Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance
NA · Haukeland University Hospital · NCT04586933
This study is testing if changing diets and adding omega-3 supplements can help people with inflammatory rheumatic diseases like rheumatoid arthritis feel better and manage their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital (other) |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT04586933 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dietary changes and omega-3 supplementation on disease activity in patients with inflammatory rheumatic diseases such as rheumatoid arthritis and spondyloarthritis. Participants will receive dietary guidance aimed at increasing omega-3 fatty acids and complete protein intake while reducing saturated fats and sugars. The study will involve collecting various health metrics, including body composition and clinical parameters, at multiple time points over a year. The goal is to determine if improved nutritional status can lead to better disease management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with rheumatoid arthritis or spondyloarthritis who can understand Norwegian and have not changed their medication in the last 12 weeks.
Not a fit: Patients with conditions that contraindicate omega-3 supplementation or those who are pregnant, lactating, or have severe illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved disease management and quality of life for patients with inflammatory rheumatic diseases.
How similar studies have performed: Previous studies have shown that dietary interventions, particularly with omega-3 fatty acids, can positively affect disease activity in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be diagnosed with one of the following diagnoses: rheumatoid arthritis, according to the ACR / EULAR 2010 criteria, psoriatic arthritis, according to the CASPAR criteria, axial spondylarthritis, including ankylosing spondylarthritis and non-radiographic spondylarthritis, according to the ASAS criteria * Duration of illness ≥0.5 years * Between 18 and 75 years * Understand Norwegian * The patient has given informed consent to participate * No change in medication the last 12 weeks before inclusion Exclusion Criteria: Diagnoses / conditions that make it difficult to follow a dietary intervention and / or supplementation of omega-3s, including: * Conditions or use of medications where omega-3 is contraindicated * Pregnancy / lactation * Allergy to soy or fish * Severe liver disease * Severe mental or physical illnesses, such as insulin-requiring diabetes
Where this trial is running
Bergen, Vestland
- Haukeland University Hospital — Bergen, Vestland, Norway (RECRUITING)
Study contacts
- Principal investigator: Anne-Kristine H Halse, MD, PhD — Haukeland University Hospital
- Study coordinator: Marie N Olsen, Msc
- Email: marienjerve@gmail.com
- Phone: 0047-95802404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spondyloarthritis, Rheumatoid Arthritis, Polyarthritis, Fatty acids, Diet, Nutritional Status