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Mediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy

NCT07170384 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Axial Spondyloarthritis (Ankylosing Spondylitis)

Interventions

BEHAVIORAL

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

BEHAVIORAL

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.

Sponsors & Collaborators

  • Sinem Kübra Beke

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170384 on ClinicalTrials.gov