Nutrition in Rheumatic Diseases

Study Overview
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Brief Summary
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Background: Patients with inflammatory rheumatic diseases (IRD) are prone to malnutrition for several reasons. The diseases and treatment can cause reduced intake and absorption of nutrients and the inflammatory processes may cause an increased demand for nutrients, especially proteins. Studies report that nutritional status can affect disease activity. Dietary supplement of 3-4 gram omega-3 has shown beneficial effect upon disease activity in patients with IRD. 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.

Detailed Description
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The study is approved by the Regional Committee for Medical and Health Research Ethics. Participation is voluntary, and informed consent will be requested. Outpatients will be recruited by doctors at the Rheumatology Department at Haukeland University Hospital (HUH). Patients recruited will be included consecutively. The recruitment period will last up to 12 months. Anthropometrical measurements, analysis of body composition, blood tests, clinical parameters, and dietary data will be collected at baseline, and after 12, 24, 36 and 52 weeks.

Official Title
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Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance

Conditions
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Spondyloarthritis, Rheumatoid Arthritis, Polyarthritis

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Placebo (soya)
* Behavioral: Dietary guidance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be twofold and consist of Intervention 1 and Intervention 2. 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3<br>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 | Dietary Supplement: Omega-3<br>* 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.<br>Behavioral: Dietary guidance<br>* Dietary guidance<br>|
| Placebo Comparator: Placebo capsules<br>Soya oil | Dietary Supplement: Placebo (soya)<br>* Placebo (soya)<br>Behavioral: Dietary guidance<br>* Dietary guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28 (Disease Activity Score 28-joint count) | Disease activity score, higher values indicate a higher disease activity and below 2.6 meaning remission. | Change between week 0, 12, 24, 36 and 52 | 
| ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) | Disease activity score, higher values indicate a higher disease activity | Change between week 0, 12, 24, 36 and 52 | 
| DAPSA (Disease Activity Index for Psoriatic Arthritis) | Disease activity score, higher values indicate a higher disease activity and below 4 meaning remission | Change between week 0, 12, 24, 36 and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAID (Rheumatoid Arthritis Impact of Disease) | Disease activity scores and scores evaluating quality of life, range 0-10, and higher scores indicate a higher grade of disability | Change between week 0, 12, 24, 36 and 52 | 
| RAND12 (short form health survey) | Disease activity scores and scores evaluating quality of life | Change between week 0, 12, 24, 36 and 52 | 
| MHAQ (Modified Health Assessment Questionnaire) | Disease activity scores and scores evaluating quality of life, range from 0 to 3 while higher values indicate a higher grade of disability | Change between week 0, 12, 24, 36 and 52 | 
| BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) | Disease activity scores and scores evaluating quality of life, range 0-10, and higher values indicate higher disease activity | Change between week 0, 12, 24, 36 and 52 | 
| BASFI (Bath Ankylosing Spondylitis Functional Index) | Disease activity scores and scores evaluating quality of life, range 0-10, and higher values indicate a higher grade of disability | Change between week 0, 12, 24, 36 and 52 | 
| CDAI (Clinical Disease Activity Index) | Disease activity scores and scores evaluating quality of life, range 0-76, and scores below 2.8 indicate remission | Change between week 0, 12, 24, 36 and 52 | 
| Consumption of medicine after 12 months | The proportion who must start or change biological treatment, use of NSAIDs and steroids | Change between baseline and week 52 | 
| BMI (Body Mass Index) | Nutritional status: Weight (kg) and height (m) will be combined to report BMI (kg/m^2) Change in BMI, waist circumference, fat mass (kg), fat-free mass (kg), fat-free mass index (kg/m2), fat-mass index (kg/m2), handgrip strength | Change between week 0, 12, 24, 36 and 52 | 
| Waist circumference | Nutritional status: Waist circumference (cm) | Change between week 0, 12, 24, 36 and 52 | 
| Handgrip strength | Nutritional status: Handgrip strength, measured by a dynamometer (kg) | Change between week 0, 12, 24, 36 and 52 | 
| Body composition | Estimation of fat mass (kg), fat-free mass (kg), measured by BIA and DXA. Fat-free mass index (kg/m2), and fat-mass index (kg/m2) will be calculated. | Change between week 0, 12, 24, 36 and 52 | 
| Dietary intake of macro- and micronutrients, based on a dietary registration of 7 days | Energy (E%, kcal) proteins (g and E%) ratio of fatty acids fibers (g) Vitamins and minerals | Week -1,10, 50 | 
| Dietary intake of macro- and micronutrients, based on a 24h recall. | Energy (E%, kcal) proteins (g and E%) ratio of fatty acids fibers (g) Vitamins and minerals | Week 0, 12, 24, 36, 52 | 
| Blood lipid profile | HDL (mmol/L) LDL (mmol/L) total cholesterol (mmol/L) triglycerides (mmol/L) | Change from week 0, 12, 24, 36 and 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatty acids, Diet, Nutritional Status