Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis

NCT07646262 | Recruiting

• 1 other identifier: HasanKU-NUT-NG-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of Life (SF-12)

  Baseline 12 weeks

Study Arms (3)

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.

Behavioral: Gluten-Free Diet Group

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.

Behavioral: Mediterranean Diet

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.

Behavioral: Control Diet

Interventions

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.

Gluten-Free Diet Group

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.

Mediterranean Diet Group

Control Diet BEHAVIORAL

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

Control Diet Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

NCR International Hospital

Gaziantep, Şehitkamil, 27560, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Nilüfer Gürsel, PhD

CONTACT

+90 506 379 73 42; nilufergursell@gmail.com

Mine Yurttagül, Prof. Dr.

CONTACT

mine@yurttagul.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: October 29, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)