Rheumatoid Arthritis (RANCT07646262
Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis
A study testing Gluten-Free Diet Group and Mediterranean Diet in people with Rheumatoid Arthritis (RA, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of different dietary interventions, including gluten-free, Mediterranean, and control diets, on disease activity, quality of life, and dietary inflammatory index in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- Gluten-Free Diet Group and Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria Age between 19-65 years Stable medication regimen for at least 3 months prior to enrollment Willingness to comply with dietary interventions and study procedures Ability to provide informed consent
Who cannot join
- Pregnancy or lactation Presence of other autoimmune or inflammatory diseases (e.g., SLE, IBD) Severe comorbidities (e.g., advanced cardiovascular, renal, or hepatic disease) Use of special diets (e.g., gluten-free diet) in the last 3 months Recent change in biologic or corticosteroid therapy (<3 months) Food allergies or intolerances affecting dietary intervention adherence Inability to comply with dietary protocol or follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mine Yurttagül, Prof. Dr. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
NCR International Hospital
Gaziantep, Şehitkamil, 27560
Nilüfer Gürsel, PhD, +90 506 379 73 42, nilufergursell@gmail.com
Nilüfer Gürsel, PhD
About this study
Official title: Investigation of the Effects of a Gluten-Free Diet and the Mediterranean Diet on the Inflammatory Index, Disease Activity, and Quality of Life in Patients With Rheumatoid Arthritis.
This study aims to evaluate the effects of different dietary interventions, including gluten-free, Mediterranean, and control diets, on disease activity, quality of life, and dietary inflammatory index in patients with rheumatoid arthritis. Participants will be followed for 12 weeks, and changes in clinical and nutritional outcomes will be assessed.
Read the detailed description
This study is a 12-week dietary intervention trial conducted in patients with rheumatoid arthritis. Participants will be assigned to three different dietary groups: gluten-free diet, Mediterranean diet, and control diet. The aim is to investigate the effects of these dietary patterns on disease activity, quality of life, and dietary inflammatory index.
Disease activity will be assessed using the DAS28 score, while quality of life will be evaluated using the SF-12 questionnaire. Dietary inflammatory index (DII) will be calculated based on dietary intake data collected throughout the study period.
Participants will be followed regularly during the 12-week intervention period, and changes in clinical and nutritional outcomes will be analyzed to determine the impact of dietary patterns on rheumatoid arthritis progression and patient well-being.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- Gluten-Free Diet Group, Mediterranean Diet, Control Diet
- Keywords
- Rheumatoid arthritis, Mediterranean diet, Gluten-free diet, Dietary inflammatory index (DII), Disease activity (DAS28)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-Free Diet GroupBehavioural
Participants will follow a gluten-free diet in which all wheat, barley, rye, and their derivatives are eliminated for 12 weeks. The diet focuses on naturally gluten-free foods such as fruits, vegetables, legumes, meat, fish, rice, and corn.
Mediterranean DietBehavioural
Participants will follow a Mediterranean dietary pattern characterized by high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with moderate consumption of dairy and low intake of red meat and processed foods for 12 weeks.
Control DietBehavioural
Participants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Gluten-Free Diet Group | Experimental | Participants will follow a gluten-free diet for 12 weeks. All gluten-containing foods will be eliminated, and dietary guidance will be provided throughout the intervention period. Receives: Behavioral: Gluten-Free Diet Group |
| Mediterranean Diet Group | Experimental | Participants will follow a Mediterranean diet for 12 weeks, emphasizing high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with limited processed foods. Receives: Behavioral: Mediterranean Diet |
| Control Diet Group | Active comparator | Participants will continue their usual diet without specific dietary modifications. General dietary advice may be provided but no structured intervention will be implemented. Receives: Behavioral: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity (DAS28)
Change in Disease Activity Score 28 (DAS28) from baseline to 12 weeks. Disease activity will be assessed using the DAS28 scoring system to evaluate changes in rheumatoid arthritis activity following dietary interventions.
Measured: 12 weeks
Secondary outcomes (1)
Quality of Life (SF-12)
Change in SF-12 health-related quality of life scores from baseline to 12 weeks. The SF-12 questionnaire will be used to assess physical and mental health status in patients with rheumatoid arthritis following dietary interventions.
Measured: Baseline 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start29 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups will receive different dietary interventions (gluten-free, Mediterranean, and control diets) over a 12-week period.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilüfer Gürsel, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646262
- Sponsor's protocol ID
- HasanKU-NUT-NG-01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be publicly shared due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of a Gluten-Free Diet and the Mediterranean Diet on the Inflammatory Index, Disease Activity, and Quality of Life in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07646262
- Acronym / sponsor ID
- HasanKU-NUT-NG-01
- Conditions
- Rheumatoid Arthritis (RA
- Keywords
- Rheumatoid arthritis, Mediterranean diet, Gluten-free diet, Dietary inflammatory index (DII), Disease activity (DAS28)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of different dietary interventions, including gluten-free, Mediterranean, and control diets, on disease activity, quality of life, and dietary inflammatory index in patients with rheumatoid arthritis. Participants will be followed for 12 weeks, and changes in clinical and nutritional outcomes will be assessed.
Detailed description
This study is a 12-week dietary intervention trial conducted in patients with rheumatoid arthritis. Participants will be assigned to three different dietary groups: gluten-free diet, Mediterranean diet, and control diet. The aim is to investigate the effects of these dietary patterns on disease activity, quality of life, and dietary inflammatory index.
Disease activity will be assessed using the DAS28 score, while quality of life will be evaluated using the SF-12 questionnaire. Dietary inflammatory index (DII) will be calculated based on dietary intake data collected throughout the study period.
Participants will be followed regularly during the 12-week intervention period, and changes in clinical and nutritional outcomes will be analyzed to determine the impact of dietary patterns on rheumatoid arthritis progression and patient well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three parallel groups will receive different dietary interventions (gluten-free, Mediterranean, and control diets) over a 12-week period.
| Arm | Type | Receives |
|---|---|---|
| Gluten-Free Diet Group | Experimental | Behavioral: Gluten-Free Diet GroupParticipants will follow a gluten-free diet for 12 weeks. All gluten-containing foods will be eliminated, and dietary guidance will be provided throughout the intervention period. |
| Mediterranean Diet Group | Experimental | Behavioral: Mediterranean DietParticipants will follow a Mediterranean diet for 12 weeks, emphasizing high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with limited processed foods. |
| Control Diet Group | Active comparator | Behavioral: Control DietParticipants will continue their usual diet without specific dietary modifications. General dietary advice may be provided but no structured intervention will be implemented. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria Age between 19-65 years Stable medication regimen for at least 3 months prior to enrollment Willingness to comply with dietary interventions and study procedures Ability to provide informed consent
Key exclusion criteria (1 listed)
- Pregnancy or lactation Presence of other autoimmune or inflammatory diseases (e.g., SLE, IBD) Severe comorbidities (e.g., advanced cardiovascular, renal, or hepatic disease) Use of special diets (e.g., gluten-free diet) in the last 3 months Recent change in biologic or corticosteroid therapy (<3 months) Food allergies or intolerances affecting dietary intervention adherence Inability to comply with dietary protocol or follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten-Free Diet GroupParticipants will follow a gluten-free diet in which all wheat, barley, rye, and their derivatives are eliminated for 12 weeks. The diet focuses on naturally gluten-free foods such as fruits, vegetables, legumes, meat, fish, rice, and corn. | Behavioural | Gluten-Free Diet Group |
| Mediterranean DietParticipants will follow a Mediterranean dietary pattern characterized by high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with moderate consumption of dairy and low intake of red meat and processed foods for 12 weeks. | Behavioural | Mediterranean Diet Group |
| Control DietParticipants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period. | Behavioural | Control Diet Group |
Primary outcome
Disease Activity (DAS28)
Time frame: 12 weeks
Change in Disease Activity Score 28 (DAS28) from baseline to 12 weeks. Disease activity will be assessed using the DAS28 scoring system to evaluate changes in rheumatoid arthritis activity following dietary interventions.
1 secondary outcome
Quality of Life (SF-12)
Time frame: Baseline 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be publicly shared due to privacy and ethical restrictions.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mine Yurttagül, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-Free Diet Group and Mediterranean Diet in people with Rheumatoid Arthritis (RA, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilüfer Gürsel, PhD (+90 506 379 73 42, nilufergursell@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity (DAS28) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.