Nutrition in Rheumatoid Arthritis

NCT06831331 | Enrolling By Invitation

• 1 other identifier: NUTRA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Individuals with Rheumatoid Arthritis (RA) often experience persistent symptoms such as pain and stiffness despite modern pharmacological treatments. They also have an increased risk of cardiovascular disease. Elevated risk factors for cardiovascular disease limit the options for symptom-relieving medications, making a reduction in these risk factors highly desirable. Diet has been shown to reduce several of these factors, but the scientific evidence for rheumatoid arthritis is limited, and thus tailored dietary advice is lacking. Objective: The purpose of the NUTRA study is to evaluate the effect of a diet that follows the updated Nordic Nutrition Recommendations (2023) on disease activity and cardiovascular risk factors in individuals with newly diagnosed RA. Specifically, the study will analyze the impact of the diet on clinically relevant markers such as blood pressure, lipid profile, inflammatory markers, and body composition. Study Plan: The study will include about 150 patients, and participants will follow a standardized care protocol where, at their three-month visit, they are randomized into either a diet following the Nordic Nutrition recommendations or a Nutrient rich diet. The intervention diets, will be added as a complementary treatment to the medications the patients are already taking. Participants will receive menus, recipes and some foods for three months, followed by self-maintenance of the diet. Clinical markers will be evaluated before the intervention as well as at three and nine months. Artificial intelligence will be used to predict which factors are crucial for achieving the best possible outcomes from dietary treatment. Significance: The NUTRA study is highly significant as it aims to generate evidence to guide the design of dietary interventions for patients with rheumatoid arthritis. By understanding the potential role of diet in reducing both disease activity and cardiovascular risk, the study may contribute to improved treatment strategies for this challenging patient group.

Conditions

Rheumatoid Arthritis (RA)

Keywords

nutrition; diet; nordic nutrition recommendations; inflammation; metabolomics; cardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

• Patterns of serum inflammatory markers

  Olink Target 96 Inflammation panel will be analysed and multivariate method (OPLS-DA) will be used to evaluate changes in the inflammatory markers between intervention and control.

  3 months dietary intervention

Secondary Outcomes (13)

• Remission yes/no

  3 months dietary intervention and at 9 months follow up

• Disease activity DAS28-CRP

  3 months dietary intervention and at 9 months follow up

• Apolipoprotein B100

  3 months dietary intervention and at 9 months follow up

• triacylglycerides

  3 months dietary intervention and at 9 months follow up

• high density lipoprotein

  3 months dietary intervention and at 9 months follow up

Other Outcomes (6)

• Body mass index (BMI)

  3 months dietary intervention and at 9 months follow up

• Body composition

  9 months follow up

• Patterns of metabolites

  3 months dietary intervention

Study Arms (2)

Nutrition recommendations (REC)

ACTIVE COMPARATOR

Diet following the Nordic Nutrition Recommendations 2023

Other: REK-diet

Nutrient rich diet, (RICH)

ACTIVE COMPARATOR

Diet rich in nutrients and with high quality protein

Other: RICH-diet

Interventions

REK-diet OTHER

Personalized diet- the participants will get individual advice how to adapt their habitual diet to the Nordic Nutrition Recommendations 2023

Nutrition recommendations (REC)

RICH-diet OTHER

Diet rich in nutrients and with high quality protein

Nutrient rich diet, (RICH)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed RA (within 3 months) that have started on Methotrexate and/or cortisone treatment. RA is defined according to the criteria from EULAR/American College of Rheumatology (ACR) 2010.
• BMI 18.5-40 kg/m2
• willing to follow the intervention diet

You may not qualify if:

• pregnancy
• lactation
• diagnosis for cancer or other life-threatening diseases
• diabetes type 1 and 2
• inflammatory bowel disease or celiac disease

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University Hospital

Gothenburg, 405 30, Sweden

Location

Related Links

• Information about the study for presumptive participants- IN SWEDISH
• About this study and previous studies within the same research area- IN SWEDISH

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant will informed that we test two different diets Care provider will not be informed about which diet the participant consume Outcome will be assessed blinded to which intervention is which
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 18, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)