Nutrition in Rheumatic Diseases (EROM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Spondyloarthritis; Polyarthritis
• Intervention / Treatment: Dietary supplement: Omega-3; Behavioral: Dietary guidance; Dietary supplement: Placebo (soya)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie N Olsen, Msc; Phone Number: 0047-95802404; Email: marienjerve@gmail.com
• Study Contact Backup: Name: Anne-Kristine H Halse, MD, PhD; Phone Number: 0047-95883957; Email: anne-kristine.halse@helse-bergen.no

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5021
      • Recruiting
      • Haukeland University Hospital
      • Contact: Anne-Kristine H. Halse, MD, PhD; Phone Number: 004755975434; Email: anne.kristine.hjorteseth.halse@helse-bergen.no
      • Sub-Investigator: Randi J. Tangvik, CD Ass Prof
      • Sub-Investigator: Bjørg-Tilde S. Fevang, MD, Prof
      • Sub-Investigator: Roy M. Nilsen, Stat. Prof.
      • Sub-Investigator: Marie N. Olsen, CD MSc
      • Principal Investigator: Anne-Kristine H. Halse, MD, Ass Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Dietary supplement: 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.; Behavioral: Dietary guidance; Dietary guidance
Placebo Comparator: Placebo capsules; Soya oil	Behavioral: Dietary guidance; Dietary guidance; Dietary supplement: Placebo (soya); Placebo (soya)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: GC Rieber Oils AS
• Investigators: Principal Investigator: Anne-Kristine H Halse, MD, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Anticipated): June 10, 2025
• Study Completion (Anticipated): June 10, 2025

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Diet; Nutritional Status; Fatty acids
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis; Rheumatic Diseases; Collagen Diseases; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 79907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in articles will be shared, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Data will be available from 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

IPD will be shared with investigators who provide a methodologically sound proposal, and whose use of data has been approved by a Human Subjects Protection Review Board.

Proposal can be directed to marienjerve@gmail.com

• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No