Rheumatoid ArthritisNCT07170033
The Effect of the DASH Diet on Treatment Outcomes in Adults Diagnosed With Rheumatoid Arthritis
A study testing Dietary Approach to Stop Hypertension (DASH) Diet in people with Rheumatoid Arthritis, run by Istanbul Health and Technology University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, it is aimed to determine the effect of the DASH diet model on the treatment of patients with seropositive rheumatoid arthritis, by evaluating its potential impact on inflammatory markers, disease activity scores, patients' functional status in daily life, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Dietary Approach to Stop Hypertension (DASH) Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 May 2024to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntary acceptance to participate in the study, Being within the age range of 18-64 years, Having a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria and belonging to the seropositive rheumatoid arthritis subgroup, Being in the active phase of rheumatoid arthritis according to the DAS-28 CRP or DAS-28 ESR disease activity score, Having a disease duration of at least 1 year, Not having previously undergone any dietary treatment specific to rheumatoid arthritis, Not using any dietary supplements other than calcium and vitamin D3 supplementation (e.g., 1000 mg calcium, 880 IU vitamin D3) recommended by the physician for patients using glucocorticoids and folic acid supplementation (10 mg weekly) recommended for patients using methotrexate, Having stable use of disease-modifying anti-rheumatic drugs (≥3 months), corticosteroids (≥4 weeks), and nonsteroidal anti-inflammatory drugs (≥10 days) before starting the DASH diet treatment, with a daily oral corticosteroid dose not exceeding 12.5 mg of prednisolone, Not having a diagnosis of eating disorders, Not being pregnant or breastfeeding, Not using banned substances, Having no intellectual disability, Having no allergy and/or intolerance to the foods included in the DASH diet
Who cannot join
- Not voluntarily agreeing to participate in the study, Not being within the age range of 18-64 years, Not having a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and not belonging to the seropositive rheumatoid arthritis subgroup, Being in remission according to the DAS-28 CRP and DAS-28 ESR disease activity scores, Having a disease duration of less than 1 year, Having previously undergone any dietary treatment specific to rheumatoid arthritis, Using any dietary supplements other than calcium and vitamin D3 supplementation (e.g., 1000 mg calcium, 880 IU vitamin D3) recommended by the physician for patients receiving glucocorticoid therapy and folic acid supplementation (10 mg weekly) recommended for patients using methotrexate, Having changes in disease-modifying anti-rheumatic drugs usage within less than 3 months, corticosteroids within less than 4 weeks, and nonsteroidal anti-inflammatory drugs within less than 10 days before starting the DASH diet treatment, having a daily oral corticosteroid dose exceeding 12.5 mg of prednisolone, Having a diagnosis of eating disorders, Being pregnant or breastfeeding, Using banned substances, Having intellectual disability, Having any allergy and/or intolerance to the foods included in the DASH diet.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Başakşehir Çam and Sakura City Hospital
Istanbul, 34480
Istanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul
About this study
Official title: A New Approach to Nutritional Therapy in Rheumatoid Arthritis: Evaluation of the Effect of the DASH Diet Through a Randomized Controlled Clinical Trial
In this study, it is aimed to determine the effect of the DASH diet model on the treatment of patients with seropositive rheumatoid arthritis, by evaluating its potential impact on inflammatory markers, disease activity scores, patients' functional status in daily life, and quality of life.
"This study is being conducted as part of a doctoral dissertation, and due to insufficient initial awareness regarding the requirement for prior registration, the registration process was completed after data collection had already begun. However, data collection is still ongoing, and the study has not yet been completed. We remain committed to full compliance with clinical trial reporting standards and transparency."
Read the detailed description
Prior to the commencement of the study, participants will be informed about the research, and those who voluntarily agree to participate will be asked to sign an informed consent form. This study, designed to determine the effect of the DASH diet on treatment outcomes in patients diagnosed with seropositive rheumatoid arthritis (RA), will collect data through a questionnaire including participants' demographic characteristics (gender, age, marital status, education level, occupation, income status), health status (duration of treatment, RA symptoms, presence of RA in relatives, use of medications and nutritional supplements, history of any RA-specific nutritional or diet therapy, presence of any chronic diseases other than RA, pregnancy/lactation status in RA patients), dietary habits (number of main and snack meals, reasons for meal skipping, foods consumed during snacks, average daily water intake, smoking and alcohol consumption), functional status in daily life, quality of life, food consumption frequency, and a 3-day dietary record. Additionally, numerical data including patients' 24-hour physical activity level, DAS-28 disease activity score, VAS general health assessment, VAS pain score, anthropometric measurements (body weight, height, and BMI), and basal metabolic rate (BMR) will be obtained.The DASH diet prescribed to patients in the intervention group will be planned according to their 24-hour physical activity level and BMR. The DASH diet adherence score will be calculated using the "Nutrition Information System (BeBiS)" program, based on the patients' dietary intake records including average daily intake of total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium, and potassium. Biochemical findings of the patients will be obtained from the patient information system with physician approval.This randomized controlled trial is planned to implement the DASH diet intervention for 3 months (12 weeks), considering similar studies in the literature, to observe the expected differences in patients with seropositive rheumatoid arthritis in the intervention group. Patients in the control group will continue their usual diet without any specific dietary intervention. Relevant data from individuals in both the intervention and control groups will be collected again at the end of weeks 4, 8, and 12 following the dietary intervention.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Dietary Approach to Stop Hypertension (DASH) Diet
- Keywords
- Diet Therapy, Inflammation, Dietary Approaches To Stop Hypertension, Randomized Controlled Trial
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Approach to Stop Hypertension (DASH) DietOther
"Dietary intervention: DASH diet" Participants in the intervention group will follow the Dietary Approaches to Stop Hypertension (DASH) diet for 12 weeks. The diet plan will be personalized based on each participant's 24-hour physical activity level and basal metabolic rate. Dietary adherence will be monitored through 3-day dietary intake records and DASH diet scores calculated using the Nutrition Information System (BeBiS). The intervention aims to assess the effect of the DASH diet on inflammatory markers, disease activity scores, functional status, and quality of life in adults diagnosed with seropositive rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| DASH Diet Group | Experimental | Participants in this group will follow the DASH diet for 12 weeks. The diet will be tailored according to individual physical activity levels and basal metabolic rate. Dietary adherence will be monitored through dietary intake records and DASH diet scores calculated using the Nutrition Information System (BeBiS). Receives: Other: Dietary Approach to Stop Hypertension (DASH) Diet |
| Control Group | No intervention | Participants in this group will continue their usual diet without any dietary intervention. They will be monitored for the same outcomes as the intervention group during the 12-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score-28 (DAS-28)
Disease activity will be assessed using the Disease Activity Score-28 (DAS-28), calculated with both C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). DAS-28 scores will be recorded at baseline, and at Weeks 4, 8, and 12. The change over time will be used to evaluate the effectiveness of the DASH diet intervention in patients with rheumatoid arthritis. According to the calculated DAS-28 score, a value of ≤3.2 indicates low disease activity; a score between >3.2 and ≤5.1 indicates moderate disease activity; and a score >5.1 indicates high disease activity. A DAS-28 score of <2.6 is defined as remission.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (4)
Change in Pain Score Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain). The change in VAS pain scores will be recorded at baseline, Week 4, Week 8, and Week 12 to evaluate the effect of the DASH diet intervention on pain levels in patients with rheumatoid arthritis. Pain intensity is classified as mild for scores <3; moderate for scores between 3 and 6; and severe for scores >6.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Biochemical Parameters
Changes in biochemical parameters (such as inflammatory markers including CRP and ESR) will be monitored at baseline, Week 4, Week 8, and Week 12 to evaluate the biochemical response to the DASH diet intervention in patients with rheumatoid arthritis.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Scores from Health Assessment Questionnaire
Scores obtained from the Health Assessment Questionnaire (HAQ) will be recorded at baseline, Week 4, Week 8, and Week 12 to assess changes in patients' functional status and overall health following the DASH diet intervention. The scale score ranges from 0 to 3, with higher scores indicating poorer health status.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Scores from the Short Form-36 (SF-36) Health Survey
Scores obtained from the Short Form-36 (SF-36) Health Survey will be recorded at baseline, Week 4, Week 8, and Week 12 in patients with rheumatoid arthritis to evaluate changes in quality of life. An increase in the scores on the scale indicates an improvement in health-related quality of life.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start6 May 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- This is a randomized, controlled, parallel-group trial in which participants diagnosed with seropositive rheumatoid arthritis will be assigned to either a DASH diet intervention group or a control group maintaining their habitual dietary intake. The study duration is 12 weeks.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Health and Technology University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gokcen Ozupek, Istanbul Health and Technology University
- Investigators
- Gökçen ÖZÜPEK, Principal investigator, Istanbul Health and Technology Universityİkbal S ALTAY, AsstProf, Study chair, Istanbul Health and Technology UniversityZeynep B KALYONCU ATASOY, AsstProf, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170033
- Sponsor's protocol ID
- ISTUN-GO-01
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozupek G, Altay IS, Kalyoncu Atasoy ZB, Torun ES. A 12-week randomized controlled trial of the dietary approaches to stop hypertension (DASH) diet in seropositive rheumatoid arthritis: Effects on disease activity and outcomes. Clin Nutr. 2026 Oct 1;66:106811. doi: 10.1016/j.clnu.2026.106811. Online ahead of print.
PubMed 42863421
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Nutritional Therapy in Rheumatoid Arthritis: Evaluation of the Effect of the DASH Diet Through a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07170033
- Acronym / sponsor ID
- ISTUN-GO-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Diet Therapy, Inflammation, Dietary Approaches To Stop Hypertension, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul Health and Technology UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 6 May 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 12 Sep 2025 (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.
In this study, it is aimed to determine the effect of the DASH diet model on the treatment of patients with seropositive rheumatoid arthritis, by evaluating its potential impact on inflammatory markers, disease activity scores, patients' functional status in daily life, and quality of life.
"This study is being conducted as part of a doctoral dissertation, and due to insufficient initial awareness regarding the requirement for prior registration, the registration process was completed after data collection had already begun. However, data collection is still ongoing, and the study has not yet been completed. We remain committed to full compliance with clinical trial reporting standards and transparency."
Detailed description
Prior to the commencement of the study, participants will be informed about the research, and those who voluntarily agree to participate will be asked to sign an informed consent form. This study, designed to determine the effect of the DASH diet on treatment outcomes in patients diagnosed with seropositive rheumatoid arthritis (RA), will collect data through a questionnaire including participants' demographic characteristics (gender, age, marital status, education level, occupation, income status), health status (duration of treatment, RA symptoms, presence of RA in relatives, use of medications and nutritional supplements, history of any RA-specific nutritional or diet therapy, presence of any chronic diseases other than RA, pregnancy/lactation status in RA patients), dietary habits (number of main and snack meals, reasons for meal skipping, foods consumed during snacks, average daily water intake, smoking and alcohol consumption), functional status in daily life, quality of life, food consumption frequency, and a 3-day dietary record. Additionally, numerical data including patients' 24-hour physical activity level, DAS-28 disease activity score, VAS general health assessment, VAS pain score, anthropometric measurements (body weight, height, and BMI), and basal metabolic rate (BMR) will be obtained.The DASH diet prescribed to patients in the intervention group will be planned according to their 24-hour physical activity level and BMR. The DASH diet adherence score will be calculated using the "Nutrition Information System (BeBiS)" program, based on the patients' dietary intake records including average daily intake of total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium, and potassium. Biochemical findings of the patients will be obtained from the patient information system with physician approval.This randomized controlled trial is planned to implement the DASH diet intervention for 3 months (12 weeks), considering similar studies in the literature, to observe the expected differences in patients with seropositive rheumatoid arthritis in the intervention group. Patients in the control group will continue their usual diet without any specific dietary intervention. Relevant data from individuals in both the intervention and control groups will be collected again at the end of weeks 4, 8, and 12 following the dietary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, parallel-group trial in which participants diagnosed with seropositive rheumatoid arthritis will be assigned to either a DASH diet intervention group or a control group maintaining their habitual dietary intake. The study duration is 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| DASH Diet Group | Experimental | Other: Dietary Approach to Stop Hypertension (DASH) DietParticipants in this group will follow the DASH diet for 12 weeks. The diet will be tailored according to individual physical activity levels and basal metabolic rate. Dietary adherence will be monitored through dietary intake records and DASH diet scores calculated using the Nutrition Information System (BeBiS). |
| Control Group | No intervention | –Participants in this group will continue their usual diet without any dietary intervention. They will be monitored for the same outcomes as the intervention group during the 12-week study period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Voluntary acceptance to participate in the study, Being within the age range of 18-64 years, Having a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria and belonging to the seropositive rheumatoid arthritis subgroup, Being in the active phase of rheumatoid arthritis according to the DAS-28 CRP or DAS-28 ESR disease activity score, Having a disease duration of at least 1 year, Not having previously undergone any dietary treatment specific to rheumatoid arthritis, Not using any dietary supplements other than calcium and vitamin D3 supplementation (e.g., 1000 mg calcium, 880 IU vitamin D3) recommended by the physician for patients using glucocorticoids and folic acid supplementation (10 mg weekly) recommended for patients using methotrexate, Having stable use of disease-modifying anti-rheumatic drugs (≥3 months), corticosteroids (≥4 weeks), and nonsteroidal anti-inflammatory drugs (≥10 days) before starting the DASH diet treatment, with a daily oral corticosteroid dose not exceeding 12.5 mg of prednisolone, Not having a diagnosis of eating disorders, Not being pregnant or breastfeeding, Not using banned substances, Having no intellectual disability, Having no allergy and/or intolerance to the foods included in the DASH diet
Key exclusion criteria (1 listed)
- Not voluntarily agreeing to participate in the study, Not being within the age range of 18-64 years, Not having a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and not belonging to the seropositive rheumatoid arthritis subgroup, Being in remission according to the DAS-28 CRP and DAS-28 ESR disease activity scores, Having a disease duration of less than 1 year, Having previously undergone any dietary treatment specific to rheumatoid arthritis, Using any dietary supplements other than calcium and vitamin D3 supplementation (e.g., 1000 mg calcium, 880 IU vitamin D3) recommended by the physician for patients receiving glucocorticoid therapy and folic acid supplementation (10 mg weekly) recommended for patients using methotrexate, Having changes in disease-modifying anti-rheumatic drugs usage within less than 3 months, corticosteroids within less than 4 weeks, and nonsteroidal anti-inflammatory drugs within less than 10 days before starting the DASH diet treatment, having a daily oral corticosteroid dose exceeding 12.5 mg of prednisolone, Having a diagnosis of eating disorders, Being pregnant or breastfeeding, Using banned substances, Having intellectual disability, Having any allergy and/or intolerance to the foods included in the DASH diet.
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 |
|---|---|---|
| Dietary Approach to Stop Hypertension (DASH) Diet"Dietary intervention: DASH diet" Participants in the intervention group will follow the Dietary Approaches to Stop Hypertension (DASH) diet for 12 weeks. The diet plan will be personalized based on each participant's 24-hour physical activity level and basal metabolic rate. Dietary adherence will be monitored through 3-day dietary intake records and DASH diet scores calculated using the Nutrition Information System (BeBiS). The intervention aims to assess the effect of the DASH diet on inflammatory markers, disease activity scores, functional status, and quality of life in adults diagnosed with seropositive rheumatoid arthritis. | Other | DASH Diet Group |
Primary outcome
Change in Disease Activity Score-28 (DAS-28)
Time frame: Baseline, Week 4, Week 8, and Week 12
Disease activity will be assessed using the Disease Activity Score-28 (DAS-28), calculated with both C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). DAS-28 scores will be recorded at baseline, and at Weeks 4, 8, and 12. The change over time will be used to evaluate the effectiveness of the DASH diet intervention in patients with rheumatoid arthritis. According to the calculated DAS-28 score, a value of ≤3.2 indicates low disease activity; a score between >3.2 and ≤5.1 indicates moderate disease activity; and a score >5.1 indicates high disease activity. A DAS-28 score of <2.6 is defined as remission.
4 secondary outcomes
Change in Pain Score Measured by Visual Analog Scale (VAS)
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Biochemical Parameters
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Scores from Health Assessment Questionnaire
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Scores from the Short Form-36 (SF-36) Health Survey
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42863421Ozupek G, Altay IS, Kalyoncu Atasoy ZB, Torun ES. A 12-week randomized controlled trial of the dietary approaches to stop hypertension (DASH) diet in seropositive rheumatoid arthritis: Effects on disease activity and outcomes. Clin Nutr. 2026 Oct 1;66:106811. doi: 10.1016/j.clnu.2026.106811. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gökçen ÖZÜPEK principal investigator
Istanbul Health and Technology University
İkbal S ALTAY, AsstProf study chair
Istanbul Health and Technology University
Zeynep B KALYONCU ATASOY, AsstProf study director
Saglik Bilimleri Universitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Approach to Stop Hypertension (DASH) Diet in people with Rheumatoid Arthritis, run by Istanbul Health and Technology University at 2 sites 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score-28 (DAS-28) (time frame: Baseline, Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07170033, which also lists 1 linked publication.
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 27 Mar 2026.