EROM: Nutrition in Rheumatic Diseases

Sponsor

Haukeland University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04586933

Collaborator

GC Rieber Oils AS (Other)

120

Enrollment

Location

Arms

17.7

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spondyloarthritis Rheumatoid Arthritis Polyarthritis	Dietary Supplement: Omega-3 Dietary Supplement: Placebo (soya) Behavioral: Dietary guidance	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 10, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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	Dietary Supplement: Placebo (soya) Placebo (soya) Behavioral: Dietary guidance Dietary guidance

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

Dietary Supplement: Placebo (soya)

Placebo (soya)

Behavioral: Dietary guidance

Dietary guidance

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
No intake of omega-3 supplementation 8 weeks before study start