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Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07646262
Enrollment
66
Registered
2026-06-12
Start date
2025-10-29
Completion date
2026-08-31
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis (RA

Keywords

Rheumatoid arthritis, Mediterranean diet, Gluten-free diet, Dietary inflammatory index (DII), Disease activity (DAS28)

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALGluten-Free Diet Group

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.

BEHAVIORALMediterranean Diet

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.

BEHAVIORALControl Diet

Participants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period.

Sponsors

Hasan Kalyoncu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Three parallel groups will receive different dietary interventions (gluten-free, Mediterranean, and control diets) over a 12-week period.

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease Activity (DAS28)12 weeksChange 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

MeasureTime frameDescription
Quality of Life (SF-12)Baseline 12 weeksChange 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTNilüfer Gürsel, PhD
nilufergursell@gmail.com+90 506 379 73 42
CONTACTMine Yurttagül, Prof. Dr.
mine@yurttagul.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026