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NCT Number: NCT07646262

Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCR International Hospital

Gaziantep, Şehitkamil, 27560, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nilüfer Gürsel, PhD

CONTACT

[email protected]

+90 506 379 73 42

Nilüfer Gürsel, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Disease Activity (DAS28)

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Quality of Life (SF-12)

    Time frame: Baseline 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mine Yurttagül, Prof. Dr.

CONTACT

[email protected]

Nilüfer Gürsel, PhD

CONTACT

[email protected]

+90 506 379 73 42

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

Investigation of the Effects of a Gluten-Free Diet and the Mediterranean Diet on the Inflammatory Index, Disease Activity, and Quality of Life in Patients With Rheumatoid Arthritis.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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