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Mediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy
Sponsor: Sinem Kübra Beke
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 spondylitis) who are receiving stable biologic therapy. Axial spondyloarthritis is a chronic inflammatory disease that affects the spine and sacroiliac joints, often leading to pain, stiffness, and reduced quality of life. While biologic disease-modifying antirheumatic drugs (bDMARDs) are effective in reducing inflammation, lifestyle factors such as diet may also play an important role in disease outcomes. In this randomized controlled trial, a total of 110 patients diagnosed with ankylosing spondylitis will be enrolled. Participants will be randomly assigned to either the Mediterranean diet group or the control group. The Mediterranean diet group will receive a structured diet program supervised by a dietitian, while the control group will continue their standard care with general healthy eating advice. Patients will be monitored for dietary adherence, and assessments will be conducted at baseline and after 3 months. The primary outcome measure is the change in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). Secondary outcomes include BASDAI, BASFI, BASMI, laboratory markers of inflammation, quality of life (SF-36), fatigue (FACIT-Fatigue), sleep quality (PSQI), anxiety and depression (HADS), medication adherence (MMAS-8), and Mediterranean diet adherence (PREDIMED). The study will provide valuable data on whether a Mediterranean diet can improve clinical outcomes and support the management of axial spondyloarthritis in patients receiving biologic therapy, potentially contributing to future lifestyle-based treatment strategies.
Official title: Evaluation of the Effect of the Mediterranean Diet on Disease Activity and Treatment Response in Patients With Axial Spondyloarthritis Receiving Biologic Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2025-09-08
Completion Date
2027-01-01
Last Updated
2025-09-12
Healthy Volunteers
No
Interventions
Mediterranean Diet
"A structured Mediterranean diet program designed and supervised by a dietitian. The program emphasizes high consumption of olive oil, vegetables, fruits, legumes, whole grains, and fish; moderate intake of dairy and poultry; and low intake of red meat and processed foods. Adherence will be monitored through 10-day interval follow-up phone calls. Assessments will be conducted at baseline and 3 months
Healthy Eating Advice
Participants will continue their standard medical treatment and will receive general healthy eating advice, as routinely recommended in clinical practice. No additional structured dietary program will be provided. Assessments will be performed at baseline and at 3 months.
Locations (1)
Erciyes University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Division of Rheumatology
Kayseri, Melikgazi, Turkey (Türkiye)