Ireland
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Enrolling by invitation Not applicable

Nutrition in Rheumatoid Arthritis

NCT06831331 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-02-25
Last updated
2026-08-21

Condition(s) studied

Rheumatoid Arthritis (RA)

Investigational drug(s) / intervention(s)

REK-dietRICH-diet

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

RICH-diet: Diet rich in nutrients and with high quality protein

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Patterns of serum inflammatory markers — 3 months dietary intervention
    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.

Trial sites (1)

FacilityCityRegionStatus
Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University Hospital Gothenburg Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06831331 on ClinicalTrials.gov ↗ ← All trials in Sweden