An interventional study of Gluten-Free Diet Group and Mediterranean Diet in Rheumatoid Arthritis (RA, sponsored by Hasan Kalyoncu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Hasan Kalyoncu University · Not applicable, Interventional, and Treatment
This study aims to evaluate the effects of different dietary interventions, including gluten-free, Mediterranean, and control diets, on disease activity, quality of life, and dietary inflammatory index in patients with rheumatoid arthritis. Participants will be followed for 12 weeks, and changes in clinical and nutritional outcomes will be assessed.
This study is a 12-week dietary intervention trial conducted in patients with rheumatoid arthritis. Participants will be assigned to three different dietary groups: gluten-free diet, Mediterranean diet, and control diet. The aim is to investigate the effects of these dietary patterns on disease activity, quality of life, and dietary inflammatory index.
Disease activity will be assessed using the DAS28 score, while quality of life will be evaluated using the SF-12 questionnaire. Dietary inflammatory index (DII) will be calculated based on dietary intake data collected throughout the study period.
Participants will be followed regularly during the 12-week intervention period, and changes in clinical and nutritional outcomes will be analyzed to determine the impact of dietary patterns on rheumatoid arthritis progression and patient well-being.
Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria Age between 19-65 years Stable medication regimen for at least 3 months prior to enrollment Willingness to comply with dietary interventions and study procedures Ability to provide informed consent
Exclusion Criteria:
Pregnancy or lactation Presence of other autoimmune or inflammatory diseases (e.g., SLE, IBD) Severe comorbidities (e.g., advanced cardiovascular, renal, or hepatic disease) Use of special diets (e.g., gluten-free diet) in the last 3 months Recent change in biologic or corticosteroid therapy (\<3 months) Food allergies or intolerances affecting dietary intervention adherence Inability to comply with dietary protocol or follow-up visits
Participants will follow a gluten-free diet for 12 weeks. All gluten-containing foods will be eliminated, and dietary guidance will be provided throughout the intervention period.
Behavioral: Gluten-Free Diet Group
Participants will follow a Mediterranean diet for 12 weeks, emphasizing high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with limited processed foods.
Behavioral: Mediterranean Diet
Participants will continue their usual diet without specific dietary modifications. General dietary advice may be provided but no structured intervention will be implemented.
Behavioral: Control Diet
Participants will follow a gluten-free diet in which all wheat, barley, rye, and their derivatives are eliminated for 12 weeks. The diet focuses on naturally gluten-free foods such as fruits, vegetables, legumes, meat, fish, rice, and corn.
Participants will follow a Mediterranean dietary pattern characterized by high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with moderate consumption of dairy and low intake of red meat and processed foods for 12 weeks.
Participants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period.
Disease Activity (DAS28)
Change in Disease Activity Score 28 (DAS28) from baseline to 12 weeks. Disease activity will be assessed using the DAS28 scoring system to evaluate changes in rheumatoid arthritis activity following dietary interventions.
Time frame: 12 weeks
Quality of Life (SF-12)
Change in SF-12 health-related quality of life scores from baseline to 12 weeks. The SF-12 questionnaire will be used to assess physical and mental health status in patients with rheumatoid arthritis following dietary interventions.
Time frame: Baseline 12 weeks
Plan to share: No — IPD will not be publicly shared due to privacy and ethical restrictions.
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Hasan Kalyoncu University