Nutrition in Rheumatic Diseases

Summary

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.

Conditions

• Spondyloarthritis
• Rheumatoid Arthritis
• Polyarthritis

Interventions

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.

DIETARY_SUPPLEMENT

Placebo (soya)

Placebo (soya)

BEHAVIORAL

Dietary guidance

Dietary guidance

Sponsors & Collaborators

• GC Rieber Oils AS

  collaborator UNKNOWN

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Anne-Kristine H Halse, MD, PhD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-10

Primary Completion

2025-06-10

Completion

2025-06-10

Countries

• Norway

Study Locations