NCT06831331: NUTRA

Nutrition in Rheumatoid Arthritis

ENROLLING BY INVITATION NA Last updated 19 March 2025

What this trial tests

NA trial testing REK-diet in Rheumatoid Arthritis (RA) in 150 participants. Enrolling by invitation.

Timeline

25 February 2025

Primary endpoint
31 December 2028

31 December 2030

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	150
Start date	25 February 2025
Primary completion	31 December 2028
Estimated completion	31 December 2030
Sites	1 location across Sweden

Drugs / interventions tested

• REK-diet
• RICH-diet

Conditions studied

• Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

Adults 18 to 85, any sex, with Rheumatoid Arthritis (RA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.