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ENROLLING BY INVITATION
NCT06831331
NA

Nutrition in Rheumatoid Arthritis

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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 some 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 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 120 patients, and participants will be randomized into either an immediate 3-month diet intervention following the Nordic Nutrition recommendations or a waitinglist control group, that will start with the diet intervention after three months. The intervention diet, 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 and after the intervention/control periods and six months after ending their intervention period. Primary outcome is ApoB. The NUTRA study 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.

Official title: NUTRA- Nutrition in Rheumatoid Arthritis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-02-25

Completion Date

2030-12-31

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

OTHER

Healthy diet based on NNR2023

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

OTHER

Control/waiting-list

Habitual diet during the waiting-period/control followed by healthy diet based on NNR2023

Locations (1)

Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University Hospital

Gothenburg, Sweden