Tests a Mediterranean diet in people with axial spondyloarthritis on biologic therapy
Tests a Mediterranean diet in adults with axial spondyloarthritis receiving biologic therapy.
Plain-language title generated from the registry record
Registry title: Mediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy
Key facts
- Where
- Kayseri, TürkiyeSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ankylosing spondylitis (axial spondyloarthritis) who are on stable biologic therapy. It tests whether a Mediterranean diet helps.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Ankylosing spondylitis diagnosed by the ASAS classification criteria
- Earlier treatment
- Must be on biologic therapy (bDMARDs) with no medication change in the last 4 months. Must be on stable NSAIDs or DMARDs for at least 4 months.
Main reasons for not taking part
- Pregnancy or breastfeeding
- Food restrictions that prevent following the Mediterranean diet, such as severe food allergies
- Another diet or exercise programme in the last 6 months
- Another rheumatologic disease or a history of neurological disorders
- Cardiac pacemaker or other reasons that rule out body composition analysis
Read by machine on 12 November 2026.
Where in Türkiye
- Erciyes University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Division of RheumatologyKayseri, TürkiyeContact: Sinem Kübra BEKE, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sinem Kübra Beke
- Trial code
- NCT07170384
- Record updated
- 12 September 2025
- Original description
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.Read full original descriptionShow less
Evaluation of the Effect of the Mediterranean Diet on Disease Activity and Treatment Response in Patients With Axial Spondyloarthritis Receiving Biologic Therapy
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.
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).