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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-12-10
2025-06-10
Brief Summary
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Aim: To investigate whether improved dietary intake with and without supplements of omega-3 will affect disease activity in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA).
Hypothesis 1: A systematic change of diet in line with the Norwegian dietary guidelines, which will result in increased intake of, among other nutrients, omega-3 fatty acids and complete protein, as well as reduced intake of saturated fat and sugar, will improve nutritional status and reduce disease activity.
Hypothesis 2: A systematic change of diet (as above), included a high dose of omega-3 will further improve nutritional status and reduce disease activity compared with placebo.
Design: A DB-RCT-study will be conducted. All patients will receive individualized dietary guidance by a clinical dietician for 12 weeks, before randomization to supplements of omega-3 or placebo, for 24 weeks. The supplement will be blinded for the participants, researchers and physicians.
Clinical implications: The study will investigate the effect of improved diet and nutrition on treatment offered to patients with IRD to provide more evidence-based knowledge, and thus specific dietary guidelines for patients with IRD. In addition, the study might increase the understanding of the role of omega-3 in the pathogenesis of inflammation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Intervention 1: Dietary guidance (12 weeks). All participants will receive individual dietary guidance, as well as an intensive dietary course with 4 sessions. Participants will receive contact information to the clinical dietitian, and the opportunity to ask questions throughout the intervention period. Patients will be asked to not use other omega-3 supplement during the intervention period 1.
Intervention 2: Omega-3 vs. placebo (24 weeks). After intervention 1, patients will be randomized to take either 3 grams of omega-3 or placebo daily, divided into 4 capsules. Patients will be asked not to use other omega-3 supplements in the period from 2 months until after intervention period 2.
TREATMENT
QUADRUPLE
Study Groups
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Omega-3
0,9 gram omega-3/capsule x 4 = 3,6 gram omega-3 daily
It will be investigated whether diet optimization followed with supplementation of omega-3s can reduce disease activity in patients with inflammatory arthritis. A new omega-3 high concentrate from GC Rieber Oils will be used
Omega-3
It will be investigated whether diet optimization and supplementation of omega-3s can reduce disease activity in patients with inflammatory arthritis. A new omega-3 high concentrate from GC Rieber Oils will be used.
Dietary guidance
Dietary guidance
Placebo capsules
Soya oil
Placebo (soya)
Placebo (soya)
Dietary guidance
Dietary guidance
Interventions
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Omega-3
It will be investigated whether diet optimization and supplementation of omega-3s can reduce disease activity in patients with inflammatory arthritis. A new omega-3 high concentrate from GC Rieber Oils will be used.
Placebo (soya)
Placebo (soya)
Dietary guidance
Dietary guidance
Eligibility Criteria
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Inclusion 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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GC Rieber Oils AS
UNKNOWN
Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Anne-Kristine H Halse, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
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Haukeland University Hospital
Bergen, Vestland, Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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79907
Identifier Type: -
Identifier Source: org_study_id
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