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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 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.

Official title: NUTRA- Nutrition in Rheumatoid Arthritis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-02-25

Completion Date

2030-12-31

Last Updated

2025-03-19

Healthy Volunteers

No

Interventions

OTHER

REK-diet

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

OTHER

RICH-diet

Diet rich in nutrients and with high quality protein

Locations (1)

Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University Hospital

Gothenburg, Sweden