Nutrition in Rheumatic Diseases

Rheumatoid Arthritis Clinical Trial

— EROM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586933
• Other study ID #: 79907
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: June 10, 2025

Study information

• Verified date: January 2023
• Source: Haukeland University Hospital
• Contact: Marie N Olsen, Msc
• Phone: 0047-95802404
• Email: marienjerve[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 10, 2025
• Est. primary completion date: June 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Collagen Diseases
• Polyarthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

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.
• Placebo (soya)
Placebo (soya)

Behavioral:
• Dietary guidance
Dietary guidance

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestland

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	GC Rieber Oils AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	RAND12 (short form health survey)	Disease activity scores and scores evaluating quality of life	Change between week 0, 12, 24, 36 and 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Waist circumference	Nutritional status: Waist circumference (cm)	Change between week 0, 12, 24, 36 and 52
Secondary	Handgrip strength	Nutritional status: Handgrip strength, measured by a dynamometer (kg)	Change between week 0, 12, 24, 36 and 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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