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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluten-Free Diet Group | Experimental | 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. |
|
| Mediterranean Diet Group | Experimental | 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. |
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| Control Diet Group | Active Comparator | Participants will continue their usual diet without specific dietary modifications. General dietary advice may be provided but no structured intervention will be implemented. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten-Free Diet Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline 12 weeks |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nilüfer Gürsel, PhD | Contact | +90 506 379 73 42 | nilufergursell@gmail.com | |
| Mine Yurttagül, Prof. Dr. | Contact | mine@yurttagul.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCR International Hospital | Recruiting | Gaziantep | Şehitkamil | 27560 | Turkey (Türkiye) |
IPD will not be publicly shared due to privacy and ethical restrictions.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Three parallel groups will receive different dietary interventions (gluten-free, Mediterranean, and control diets) over a 12-week period.
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| Mediterranean Diet | Behavioral | 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. |
|
| Control Diet | Behavioral | Participants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period. |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |