Status:
NOT_YET_RECRUITING
Mediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy
Lead Sponsor:
Sinem Kübra Beke
Conditions:
Axial Spondyloarthritis (Ankylosing Spondylitis)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to evaluate the effect of the Mediterranean diet on disease activity, quality of life, inflammation, pain, and treatment response in patients with axial spondyloarthritis (ankylosing s...
Detailed Description
Aim This study is designed to investigate the effects of the Mediterranean diet on disease activity, quality of life, inflammation levels, pain scores, and the frequency of biologic DMARD use in patie...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Diagnosis of ankylosing spondylitis according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria.
- No dietary changes within the past 3 months.
- Stable treatment with NSAIDs or DMARDs for at least the previous 4 months.
- Receiving biologic therapy (bDMARDs) with no changes in medication for the last 4 months.
- Willingness and ability to provide written informed consent
Exclusion
- Pregnancy or breastfeeding.
- Nutritional restrictions preventing adherence to the Mediterranean diet (e.g., severe food allergies).
- Participation in another diet- or exercise-based intervention program within the last 6 months.
- Presence of another rheumatologic disease or history of neurological disorders.
- Individuals younger than 18 years.
- Contraindications to body composition analysis (e.g., cardiac pacemaker, pregnancy).
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07170384
Start Date
September 8 2025
End Date
January 1 2027
Last Update
September 12 2025
Active Locations (1)
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1
Erciyes University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Division of Rheumatology
Kayseri, Melikgazi, Turkey (Türkiye), 38039