Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorHasan Kalyoncu University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Gluten-Free Diet GroupExperimental treatment 1 intervention
Group B: Mediterranean Diet GroupExperimental treatment 1 intervention
Group C: Control Diet GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.