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Enrolling By Invitation NCT06831331

Nutrition in Rheumatoid Arthritis

Conditions: Rheumatoid Arthritis (RA)

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Vastra Gotaland Region

Location: Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University Hospital Gothenburg

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * pregnancy * lactation * diagnosis for cancer or other life-threatening diseases * diabetes type 1 and 2 * inflammatory bowel disease or celiac disease

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06831331). StuddyBuddy aggregates publicly available trial information.