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Mediterranean diet tested as Add-On for spine arthritis

NCT ID NCT07170384

Disease control Sponsor: Sinem Kübra Beke Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a Mediterranean diet can lower disease activity and improve quality of life in 110 people with axial spondyloarthritis (a type of arthritis affecting the spine) who are already on biologic therapy. Participants will either follow a structured Mediterranean diet or receive general healthy eating advice for 3 months. Researchers will measure changes in inflammation, pain, fatigue, and sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mediterranean diet
What this could lead to
If it works, this could show that a Mediterranean diet helps reduce inflammation and improve symptoms in people with axial spondyloarthritis, potentially adding a simple lifestyle tool to standard care.
What could go wrong
This is a small, early-stage trial with only 110 participants and a short 3-month follow-up. Diet changes can be hard to stick with, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondyloarthritis (ankylosing spondylitis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erciyes University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Division of Rheumatology

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)