NCT07170384Not yet recruiting
Mediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy
Evaluation of the Effect of the Mediterranean Diet on Disease Activity and Treatment Response in Patients With Axial Spondyloarthritis Receiving Biologic Therapy
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 8 Sept 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Sinem Kübra Beke
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07170384
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 8 Sept 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erciyes University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Division of Rheumatology Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.